Approved/cleared anti-obesity medical devices in the USA ranked by approval date.
\\n\\n
IntechOpen was founded by scientists, for scientists, in order to make book publishing accessible around the globe. Over the last two decades, this has driven Open Access (OA) book publishing whilst levelling the playing field for global academics. Through our innovative publishing model and the support of the research community, we have now published over 5,700 Open Access books and are visited online by over three million academics every month. These researchers are increasingly working in broad technology-based subjects, driving multidisciplinary academic endeavours into human health, environment, and technology.
\\n\\nBy listening to our community, and in order to serve these rapidly growing areas which lie at the core of IntechOpen's expertise, we are launching a portfolio of Open Science journals:
\\n\\nAll three journals will publish under an Open Access model and embrace Open Science policies to help support the changing needs of academics in these fast-moving research areas. There will be direct links to preprint servers and data repositories, allowing full reproducibility and rapid dissemination of published papers to help accelerate the pace of research. Each journal has renowned Editors in Chief who will work alongside a global Editorial Board, delivering robust single-blind peer review. Supported by our internal editorial teams, this will ensure our authors will receive a quick, user-friendly, and personalised publishing experience.
\\n\\n"By launching our journals portfolio we are introducing new, dedicated homes for interdisciplinary technology-focused researchers to publish their work, whilst embracing Open Science and creating a unique global home for academics to disseminate their work. We are taking a leap toward Open Science continuing and expanding our fundamental commitment to openly sharing scientific research across the world, making it available for the benefit of all." Dr. Sara Uhac, IntechOpen CEO
\\n\\n"Our aim is to promote and create better science for a better world by increasing access to information and the latest scientific developments to all scientists, innovators, entrepreneurs and students and give them the opportunity to learn, observe and contribute to knowledge creation. Open Science promotes a swifter path from research to innovation to produce new products and services." Alex Lazinica, IntechOpen founder
\\n\\nIn conclusion, Natalia Reinic Babic, Head of Journal Publishing and Open Science at IntechOpen adds:
\\n\\n“On behalf of the journal team I’d like to thank all our Editors in Chief, Editorial Boards, internal supporting teams, and our scientific community for their continuous support in making this portfolio a reality - we couldn’t have done it without you! With your support in place, we are confident these journals will become as impactful and successful as our book publishing program and bring us closer to a more open (science) future.”
\\n\\nWe invite you to visit the journals homepage and learn more about the journal’s Editorial Boards, scope and vision as all three journals are now open for submissions.
\\n\\nFeel free to share this news on social media and help us mark this memorable moment!
\\n\\n\\n"}]',published:!0,mainMedia:{caption:"",originalUrl:"/media/original/237"}},components:[{type:"htmlEditorComponent",content:'
After years of being acknowledged as the world's leading publisher of Open Access books, today, we are proud to announce we’ve successfully launched a portfolio of Open Science journals covering rapidly expanding areas of interdisciplinary research.
\n\n\n\nIntechOpen was founded by scientists, for scientists, in order to make book publishing accessible around the globe. Over the last two decades, this has driven Open Access (OA) book publishing whilst levelling the playing field for global academics. Through our innovative publishing model and the support of the research community, we have now published over 5,700 Open Access books and are visited online by over three million academics every month. These researchers are increasingly working in broad technology-based subjects, driving multidisciplinary academic endeavours into human health, environment, and technology.
\n\nBy listening to our community, and in order to serve these rapidly growing areas which lie at the core of IntechOpen's expertise, we are launching a portfolio of Open Science journals:
\n\nAll three journals will publish under an Open Access model and embrace Open Science policies to help support the changing needs of academics in these fast-moving research areas. There will be direct links to preprint servers and data repositories, allowing full reproducibility and rapid dissemination of published papers to help accelerate the pace of research. Each journal has renowned Editors in Chief who will work alongside a global Editorial Board, delivering robust single-blind peer review. Supported by our internal editorial teams, this will ensure our authors will receive a quick, user-friendly, and personalised publishing experience.
\n\n"By launching our journals portfolio we are introducing new, dedicated homes for interdisciplinary technology-focused researchers to publish their work, whilst embracing Open Science and creating a unique global home for academics to disseminate their work. We are taking a leap toward Open Science continuing and expanding our fundamental commitment to openly sharing scientific research across the world, making it available for the benefit of all." Dr. Sara Uhac, IntechOpen CEO
\n\n"Our aim is to promote and create better science for a better world by increasing access to information and the latest scientific developments to all scientists, innovators, entrepreneurs and students and give them the opportunity to learn, observe and contribute to knowledge creation. Open Science promotes a swifter path from research to innovation to produce new products and services." Alex Lazinica, IntechOpen founder
\n\nIn conclusion, Natalia Reinic Babic, Head of Journal Publishing and Open Science at IntechOpen adds:
\n\n“On behalf of the journal team I’d like to thank all our Editors in Chief, Editorial Boards, internal supporting teams, and our scientific community for their continuous support in making this portfolio a reality - we couldn’t have done it without you! With your support in place, we are confident these journals will become as impactful and successful as our book publishing program and bring us closer to a more open (science) future.”
\n\nWe invite you to visit the journals homepage and learn more about the journal’s Editorial Boards, scope and vision as all three journals are now open for submissions.
\n\nFeel free to share this news on social media and help us mark this memorable moment!
\n\n\n'}],latestNews:[{slug:"webinar-introduction-to-open-science-wednesday-18-may-1-pm-cest-20220518",title:"Webinar: Introduction to Open Science | Wednesday 18 May, 1 PM CEST"},{slug:"step-in-the-right-direction-intechopen-launches-a-portfolio-of-open-science-journals-20220414",title:"Step in the Right Direction: IntechOpen Launches a Portfolio of Open Science Journals"},{slug:"let-s-meet-at-london-book-fair-5-7-april-2022-olympia-london-20220321",title:"Let’s meet at London Book Fair, 5-7 April 2022, Olympia London"},{slug:"50-books-published-as-part-of-intechopen-and-knowledge-unlatched-ku-collaboration-20220316",title:"50 Books published as part of IntechOpen and Knowledge Unlatched (KU) Collaboration"},{slug:"intechopen-joins-the-united-nations-sustainable-development-goals-publishers-compact-20221702",title:"IntechOpen joins the United Nations Sustainable Development Goals Publishers Compact"},{slug:"intechopen-signs-exclusive-representation-agreement-with-lsr-libros-servicios-y-representaciones-s-a-de-c-v-20211123",title:"IntechOpen Signs Exclusive Representation Agreement with LSR Libros Servicios y Representaciones S.A. de C.V"},{slug:"intechopen-expands-partnership-with-research4life-20211110",title:"IntechOpen Expands Partnership with Research4Life"},{slug:"introducing-intechopen-book-series-a-new-publishing-format-for-oa-books-20210915",title:"Introducing IntechOpen Book Series - A New Publishing Format for OA Books"}]},book:{item:{type:"book",id:"9815",leadTitle:null,fullTitle:"Cystic Fibrosis - Facts, Management and Advances",title:"Cystic Fibrosis",subtitle:"Facts, Management and Advances",reviewType:"peer-reviewed",abstract:"Cystic fibrosis, a genetic disorder in children and young adults, is a multisystemic disease that mainly affects the lungs. Advances and improvements in the diagnosis and management of this condition have led to increased overall and symptom-free survival in cystic fibrosis patients. This book examines recent advances in the field and presents an evidence-based approach to the management of cystic fibrosis.",isbn:"978-1-83881-074-0",printIsbn:"978-1-83881-073-3",pdfIsbn:"978-1-83881-075-7",doi:"10.5772/intechopen.87623",price:119,priceEur:129,priceUsd:155,slug:"cystic-fibrosis-facts-management-and-advances",numberOfPages:124,isOpenForSubmission:!1,isInWos:null,isInBkci:!1,hash:"69745423f00df1a6b73be06d7ae13601",bookSignature:"Prashant Mohite, Anna Reed and André R. Simon",publishedDate:"June 9th 2021",coverURL:"https://cdn.intechopen.com/books/images_new/9815.jpg",numberOfDownloads:2046,numberOfWosCitations:0,numberOfCrossrefCitations:0,numberOfCrossrefCitationsByBook:0,numberOfDimensionsCitations:1,numberOfDimensionsCitationsByBook:0,hasAltmetrics:1,numberOfTotalCitations:1,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"November 6th 2019",dateEndSecondStepPublish:"March 2nd 2020",dateEndThirdStepPublish:"May 1st 2020",dateEndFourthStepPublish:"July 20th 2020",dateEndFifthStepPublish:"September 18th 2020",currentStepOfPublishingProcess:5,indexedIn:"1,2,3,4,5,6",editedByType:"Edited by",kuFlag:!1,featuredMarkup:null,editors:[{id:"286049",title:"Dr.",name:"Prashant",middleName:null,surname:"Mohite",slug:"prashant-mohite",fullName:"Prashant Mohite",profilePictureURL:"https://mts.intechopen.com/storage/users/286049/images/system/286049.png",biography:"Prashant Mohite is trained as a cardiac surgeon in India and works as a Locum Consultant in Cardiac Retrieval at Golden Jubilee National Hospital. He was involved in the development of several programs at Harefield Hospital, England, including Organ Care Systems for heart and lungs, ex vivo lung perfusion, awake extracorporeal life support (ECLS), ECLS as a bridge to lung transplant, and donation after cardiac death (DCD) heart transplantation. He is an avid researcher having published in well-known journals and presented at multiple national and international meetings as an invited speaker as well as through voluntary abstract submissions.",institutionString:"Royal Brompton and Harefield NHS Foundation Trust",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"3",totalChapterViews:"0",totalEditedBooks:"1",institution:{name:"Royal Brompton & Harefield NHS Foundation Trust",institutionURL:null,country:{name:"United Kingdom"}}}],equalEditorOne:null,equalEditorTwo:null,equalEditorThree:null,coeditorOne:{id:"313411",title:"Dr.",name:"Anna",middleName:null,surname:"Reed",slug:"anna-reed",fullName:"Anna Reed",profilePictureURL:"https://mts.intechopen.com/storage/users/313411/images/system/313411.png",biography:"Dr. Anna Reed is a consultant in respiratory and transplant medicine, based at Harefield Hospital, England. She graduated from Leeds University in 1998 and obtained a Ph.D. in Pulmonary Vascular Pharmacology from Imperial College London in 2011. She maintains an active research interest in areas such as surfactant flux in primary graft dysfunction, ECMO bridging to lung transplant, pharmacokinetic and pharmacodynamic alterations of commonly used anti-infectives on extracorporeal life support, Aspergillus disease and the immunological impact on the transplanted lung, and more. She has authored multiple manuscripts in high-profile journals and has reviewed numerous journal articles.",institutionString:"Royal Brompton and Harefield NHS Foundation Trust",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"1",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Royal Brompton & Harefield NHS Foundation Trust",institutionURL:null,country:{name:"United Kingdom"}}},coeditorTwo:{id:"301441",title:"Dr.",name:"André",middleName:"R.",surname:"Simon",slug:"andre-simon",fullName:"André Simon",profilePictureURL:"https://mts.intechopen.com/storage/users/301441/images/system/301441.jpg",biography:"André R. Simon is a consultant cardiac surgeon and director of heart and lung transplantation and ventricular assist devices at Harefield Hospital, England. He is also an honorary senior lecturer at Imperial College London. He has written more than 100 peer-reviewed papers, reviews, and editorials. He has also contributed chapters to several textbooks. He has raised more than £2 million in funding for research into transplantation immunology, cardiac imaging, and ventricular assist devices. Dr. Simon is the founder and president of HeartHelp, a charitable non-government organization.",institutionString:"Royal Brompton and Harefield NHS Foundation Trust",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"2",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"Royal Brompton & Harefield NHS Foundation Trust",institutionURL:null,country:{name:"United Kingdom"}}},coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"1047",title:"Pulmonology",slug:"pulmonology"}],chapters:[{id:"76709",title:"Introductory Chapter: Basics of Cystic Fibrosis",doi:"10.5772/intechopen.97537",slug:"introductory-chapter-basics-of-cystic-fibrosis",totalDownloads:202,totalCrossrefCites:0,totalDimensionsCites:0,hasAltmetrics:0,abstract:null,signatures:"Prashant N. Mohite and Vicky Gerovasili",downloadPdfUrl:"/chapter/pdf-download/76709",previewPdfUrl:"/chapter/pdf-preview/76709",authors:[{id:"286049",title:"Dr.",name:"Prashant",surname:"Mohite",slug:"prashant-mohite",fullName:"Prashant Mohite"},{id:"416266",title:"Dr.",name:"Vicky",surname:"Gerovasili",slug:"vicky-gerovasili",fullName:"Vicky Gerovasili"}],corrections:null},{id:"72407",title:"Cystic Fibrosis-Related Diabetes (CFRD)",doi:"10.5772/intechopen.92767",slug:"cystic-fibrosis-related-diabetes-cfrd-",totalDownloads:373,totalCrossrefCites:0,totalDimensionsCites:0,hasAltmetrics:0,abstract:"Cystic fibrosis-related diabetes (CFRD) is the most frequent comorbidity in CF. The prevalence is age-dependent and abnormalities in/of glucose homeostasis start early in life. As CFRD has an impact on pulmonary function and life expectancy, early diagnosis and treatment is mandatory. Screening is needed because initially, most patients with CFRD do not show any typical symptoms of diabetes. The question of which screening method gets the best results is still under discussion. For treatment insulin is recommended but a relevant percentage of patients do not use it, and even if insulin is used, there is no consensus on what the best insulin regime in the case of CFRD is. Recently, oral antidiabetic drugs were shown to be as effective and safe as insulin in the initial treatment of CFRD. This treatment might reduce the additional treatment burden for patients with CFRD. The best way to monitor CFRD is also under discussion (HbA1c and/or continuous glucose monitoring; CGM). The threshold of HbA1c might be lower than for other types of diabetes. As patients with CF become older, the duration of CFRD will also increase and typical diabetes complications will occur. So far, these are mainly microvascular complications. The new CFTR modulators might influence not only pulmonary function but potentially also glucose homeostasis.",signatures:"Manfred Ballmann",downloadPdfUrl:"/chapter/pdf-download/72407",previewPdfUrl:"/chapter/pdf-preview/72407",authors:[{id:"314947",title:"Prof.",name:"Manfred",surname:"Ballmann",slug:"manfred-ballmann",fullName:"Manfred Ballmann"}],corrections:null},{id:"72572",title:"Detection and Management of Early Glucose Abnormalities in Cystic Fibrosis",doi:"10.5772/intechopen.92847",slug:"detection-and-management-of-early-glucose-abnormalities-in-cystic-fibrosis",totalDownloads:483,totalCrossrefCites:0,totalDimensionsCites:0,hasAltmetrics:1,abstract:"With advances in technology, it is now possible to detect the emergence of glucose abnormalities in cystic fibrosis with improved sensitivity, and from a very early age. These abnormalities are increasingly recognized as predictors of clinical decline, raising the possibility that early intervention may slow or prevent this deterioration. In this chapter, we will review the available literature on methods of detecting glucose abnormalities in cystic fibrosis (random and fasting glucose, HbA1c, oral glucose tolerance testing, and continuous glucose monitoring), and detail their advantages and possible limitations in the interpretation of glycemic data. We will also discuss treatment outcomes of early intervention, prior to the diagnosis of diabetes as currently defined.",signatures:"Katerina Theocharous, Bernadette Prentice, Charles F. Verge, Adam Jaffé and Shihab Hameed",downloadPdfUrl:"/chapter/pdf-download/72572",previewPdfUrl:"/chapter/pdf-preview/72572",authors:[{id:"196333",title:"Dr.",name:"Bernadette",surname:"Prentice",slug:"bernadette-prentice",fullName:"Bernadette Prentice"},{id:"197023",title:"Dr.",name:"Shihab",surname:"Hameed",slug:"shihab-hameed",fullName:"Shihab Hameed"},{id:"197024",title:"Dr.",name:"Charles F.",surname:"Verge",slug:"charles-f.-verge",fullName:"Charles F. Verge"},{id:"320031",title:"Ms.",name:"Katerina",surname:"Theocharous",slug:"katerina-theocharous",fullName:"Katerina Theocharous"},{id:"320928",title:"Prof.",name:"Adam",surname:"Jaffe",slug:"adam-jaffe",fullName:"Adam Jaffe"}],corrections:null},{id:"71325",title:"Microbial Cystic Fibrosis",doi:"10.5772/intechopen.91628",slug:"microbial-cystic-fibrosis",totalDownloads:319,totalCrossrefCites:0,totalDimensionsCites:0,hasAltmetrics:0,abstract:"Cystic fibrosis (CF) is the most common genetic disease in Caucasians that increases the mortality rate. This disease retards the passage of water and salt through the cells and therefore affects the vital functions of different organs. Pulmonary cystic fibrosis is the most common and responsible for the majority of symptoms, burden of care, and mortality. The gene that causes the disease has now been identified and sequenced. The lung diseases with CF are usually have three pathological elements; mucus obstruction, inflammation, and infection. In the last century, the relationship between CF, respiratory microbiology, and inflammation has been understood with increased longevity and development of new treatments and laboratory techniques. In this chapter, we will illustrate causes of CF lung diseases and modern therapeutic strategies.",signatures:"Waleed Mohamed Abdulkhair and Mousa Abdullah Alghuthaymi",downloadPdfUrl:"/chapter/pdf-download/71325",previewPdfUrl:"/chapter/pdf-preview/71325",authors:[{id:"175713",title:"Dr.",name:"Waleed Mohamed Hussain",surname:"Abdulkhair",slug:"waleed-mohamed-hussain-abdulkhair",fullName:"Waleed Mohamed Hussain Abdulkhair"},{id:"315906",title:"Dr.",name:"Mousa",surname:"Alghuthaymi",slug:"mousa-alghuthaymi",fullName:"Mousa Alghuthaymi"}],corrections:null},{id:"74734",title:"Lung Transplantation in Patients with Cystic Fibrosis",doi:"10.5772/intechopen.94523",slug:"lung-transplantation-in-patients-with-cystic-fibrosis",totalDownloads:334,totalCrossrefCites:0,totalDimensionsCites:0,hasAltmetrics:0,abstract:"Cystic fibrosis (CF) is one of the most common indications for lung transplant (LTx) and nearly one-third of the LTx worldwide are performed in people with CF (PwCF). Due to vast developments in diagnostic modalities, antibiotic therapies, and management of associated comorbidities in dedicated and experienced centres, over the past few decades, more PwCF are reaching adulthood than ever before. This has increased the burden on transplant programs particularly in a universal donor shortage scenario. To improve the donor pool a diligent and proactive donor care management, acceptance of marginal organs and utilisation of ex-vivo lung perfusion systems for organ preservation, assessment, and improvement is being advocated widely. LTx is not a readily available therapy and the average waiting time is 18 months in the UK. Therefore, it is essential that PwCF are referred for LTx assessment when their disease is stable, before respiratory deterioration leads to overall deconditioning of the patients. Once listed for LTx, it is crucial to control waiting list mortality by prioritising rapidly deteriorating patients through schemes like the lung allocation score, national urgent and super-urgent waiting lists, and institutional highlighting of deteriorating patients that do not meet other urgent criteria. LTx in PwCF is challenging due to colonisation of the respiratory tract with multi-drug resistant organisms, associated comorbidities such as diabetes, liver disease, gastro-oesophageal reflux, and distal intestinal obstruction syndrome (DIOS) and CF-specific technical difficulties (adhesions due to prior pneumothoraces or pleurodesis, or bronchial collaterals that increase surgical time). Hilar lymphadenopathy and bronchial collaterals may increase surgical time, organ ischemia time, intra and post-operative bleeding, and blood transfusions. Advances in immunosuppression, prophylactic anti-viral and anti-fungal therapies, early ambulation and rigorous physiotherapy, and meticulous postoperative follow up with spirometry, x-rays, and bronchoscopies to detect rejection at the early stage followed by its efficient treatment have helped to improve post-LTx survival in the CF patients. Constant development in the surgical field with adoption of off-pump transplantation, sternal sparing bilateral thoracotomy approach, and utilisation of mechanical circulatory assist as a bridge to transplant and as a support for primary graft failure strives for better outcomes. However, chronic lung allograft dysfunction, chronic refractory infections, malignancies, and CF associated comorbidities remain major determinants of post-LTx long term survival. Despite this, CF patients are often good candidates for re-do LTx with improving survival outcomes. In this chapter, we are compiling the different aspects of LTx in PwCF emphasising the advances in bridge to transplantation, the surgical approach, management of primary graft failure, and immunosuppression as well as complications post-transplant.",signatures:"Prashant N. Mohite, Kavita Dave, Anna Reed and André R. Simon",downloadPdfUrl:"/chapter/pdf-download/74734",previewPdfUrl:"/chapter/pdf-preview/74734",authors:[{id:"286049",title:"Dr.",name:"Prashant",surname:"Mohite",slug:"prashant-mohite",fullName:"Prashant Mohite"},{id:"313411",title:"Dr.",name:"Anna",surname:"Reed",slug:"anna-reed",fullName:"Anna Reed"},{id:"301441",title:"Dr.",name:"André",surname:"Simon",slug:"andre-simon",fullName:"André Simon"},{id:"329517",title:"Dr.",name:"Kavita",surname:"Dave",slug:"kavita-dave",fullName:"Kavita Dave"}],corrections:null},{id:"72305",title:"Recent Advances in Targeted Genetic Medicines for Cystic Fibrosis",doi:"10.5772/intechopen.92434",slug:"recent-advances-in-targeted-genetic-medicines-for-cystic-fibrosis",totalDownloads:335,totalCrossrefCites:0,totalDimensionsCites:1,hasAltmetrics:0,abstract:"The cystic fibrosis transmembrane conductance regulator (CFTR) gene was discovered just over 30 years ago, and soon after, gene therapy for cystic fibrosis (CF) has been rapidly and continually developing. Recently, novel gene therapy strategies have been developed, including mRNA delivery, genome editing, and mRNA repair; all these strategies are collectively named “genetic medicines.” The last quarter of the century showed a significant boost in the development of viral and nonviral vectors to deliver genetic treatment. This chapter will provide a brief overview of the CFTR gene and its different classes of mutations as well as a review of the different genetic therapeutic options that are under research. Later in this chapter, drugs that target different CFTR mutation classes and are currently approved to treat CF patients will be briefly presented.",signatures:"Salsabil Elboraie, Konstantinos N. Kafetzis, Rajeev Shrivastava and Aristides D. 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\r\n\tThis book is intended to serve as a guide and support to those undergraduate, postgraduate students, and researchers interested in understanding the process of dynamical evaluation of discrete and continuous systems with behavior from fixed points to chaos and vice-versa, and also to those who are interested in the most recent knowledge about fixed points evolution to chaos. Some dynamical systems are designated to have well-defined behavior but under certain not previewed conditions, the behavior of those systems could evolve into a very complex dynamical response. By the use of adequate mathematical tools, the complex behavior produced by unstable fixed points could be studied, characterized, and in most cases controlled. Moreover, it is well known that systems evaluated from fractional calculus models are capable to present stable, and unstable fixed points, and variations of them under parametric modification or variation in the integration order, which also could be controlled under different control mechanisms.
",isbn:"978-1-83768-436-6",printIsbn:"978-1-83768-435-9",pdfIsbn:"978-1-83768-437-3",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!0,isSalesforceBook:!1,isNomenclature:!1,hash:"256aaeeb2cfa765c6a37c73e4fe7402f",bookSignature:"Dr. Guillermo Huerta-Cuellar",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/12020.jpg",keywords:"Stability of Fixed Points, Banach Fixed Points Theorem, Fractional Calculus, Discontinuity of Fixed Points, Stability of Systems, Route to Chaos, Multistability, Perturbations Theory, Unstable Fixed Points, Adaptive Control, Control of Discrete-Time Chaotic Systems, Pseudo-Random Bit Generator",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:null,numberOfDimensionsCitations:null,numberOfTotalCitations:null,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"June 17th 2022",dateEndSecondStepPublish:"July 15th 2022",dateEndThirdStepPublish:"September 13th 2022",dateEndFourthStepPublish:"December 2nd 2022",dateEndFifthStepPublish:"January 31st 2023",dateConfirmationOfParticipation:null,remainingDaysToSecondStep:"18 days",secondStepPassed:!1,areRegistrationsClosed:!1,currentStepOfPublishingProcess:2,editedByType:null,kuFlag:!1,biosketch:"Dr. Guillermo Huerta Cuellar is a researcher in the area of nonlinear dynamics and chaotic systems, with experimental and theoretical results. Has been an author of more than 40 high-level papers, and academic editor in 4 journals, and 3 books.",coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"237167",title:"Dr.",name:"Guillermo",middleName:null,surname:"Huerta-Cuellar",slug:"guillermo-huerta-cuellar",fullName:"Guillermo Huerta-Cuellar",profilePictureURL:"https://mts.intechopen.com/storage/users/237167/images/system/237167.jpg",biography:"Guillermo Huerta Cuellar received a B.Sc. degree from Instituto de Investigación en\r\nComunicaciones Ópticas (IICO), from the Universidad Autónoma de San Luis Potosí, San Luis\r\nPotosí in 2004. After, he received a Ph.D. degrees from Centro de Investigaciones en Óptica\r\n(CIO), León Guanajuato, Mexico, in 2009. During 2010 to present he have been working at the\r\nExact Sciences and Technology Department in Centro Universitario de los Lagos, Universidad de\r\nGuadalajara. He has been Visiting Researcher in the department of Applied Mathematics at\r\nInstituto Potosino de Investigación Científica y Tecnológica, San Luis Potosí, México (2012-\r\n2014), in Department of Theory of Oscillations and Automatic Control, Faculty of Radiophysics,\r\nLobachevsky State University of Nizhny Novgorod, Russia (2016), sabbatical stay in the\r\nDepartment of Physics and Environmental Science at St. Mary's University, San Antonio, TX, US\r\n(2018-2019), and in División de Matemáticas Aplicadas, Instituto Potosino de Investigación\r\nCientífica y Tecnológica (IPICYT), in San Luis Potosí, S. L. P., México (2019-2020). He has\r\neditor of 3 books, and coauthor of 6 book chapters, international journals and conferences, and\r\nmore of 40 high impact publications. He is member in the National System for Researchers (SNI-\r\nCONACyT-México). He participates as Academic Editor in the Journal Complexity (2021),\r\nFrontiers in Applied Mathematics and Statistics (2022), and Axioms (2022). He has participations\r\nas a reviewer in high impact-factor journals. His research interests include study, characterization,\r\ndynamical behavior and design in nonlinear dynamical systems as lasers, electronics, and in\r\nnumerical models.",institutionString:"University of Guadalajara",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"2",totalChapterViews:"0",totalEditedBooks:"2",institution:{name:"University of Guadalajara",institutionURL:null,country:{name:"Mexico"}}}],coeditorOne:null,coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"15",title:"Mathematics",slug:"mathematics"}],chapters:null,productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"},personalPublishingAssistant:{id:"478197",firstName:"Veronika",lastName:"Radosavac",middleName:null,title:"Dr.",imageUrl:"//cdnintech.com/web/frontend/www/assets/author.svg",email:"veronika@intechopen.com",biography:null}},relatedBooks:[{type:"book",id:"1591",title:"Infrared Spectroscopy",subtitle:"Materials Science, Engineering and Technology",isOpenForSubmission:!1,hash:"99b4b7b71a8caeb693ed762b40b017f4",slug:"infrared-spectroscopy-materials-science-engineering-and-technology",bookSignature:"Theophile Theophanides",coverURL:"https://cdn.intechopen.com/books/images_new/1591.jpg",editedByType:"Edited by",editors:[{id:"37194",title:"Dr.",name:"Theophile",surname:"Theophanides",slug:"theophile-theophanides",fullName:"Theophile Theophanides"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"3161",title:"Frontiers in Guided Wave Optics and Optoelectronics",subtitle:null,isOpenForSubmission:!1,hash:"deb44e9c99f82bbce1083abea743146c",slug:"frontiers-in-guided-wave-optics-and-optoelectronics",bookSignature:"Bishnu Pal",coverURL:"https://cdn.intechopen.com/books/images_new/3161.jpg",editedByType:"Edited by",editors:[{id:"4782",title:"Prof.",name:"Bishnu",surname:"Pal",slug:"bishnu-pal",fullName:"Bishnu Pal"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"3092",title:"Anopheles mosquitoes",subtitle:"New insights into malaria vectors",isOpenForSubmission:!1,hash:"c9e622485316d5e296288bf24d2b0d64",slug:"anopheles-mosquitoes-new-insights-into-malaria-vectors",bookSignature:"Sylvie Manguin",coverURL:"https://cdn.intechopen.com/books/images_new/3092.jpg",editedByType:"Edited by",editors:[{id:"50017",title:"Prof.",name:"Sylvie",surname:"Manguin",slug:"sylvie-manguin",fullName:"Sylvie Manguin"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"371",title:"Abiotic Stress in Plants",subtitle:"Mechanisms and Adaptations",isOpenForSubmission:!1,hash:"588466f487e307619849d72389178a74",slug:"abiotic-stress-in-plants-mechanisms-and-adaptations",bookSignature:"Arun Shanker and B. 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In these networks, data are transmitted over all‐optical WDM channels called lightpaths. A connection is established by utilizing a lightpath, which is determined by choosing a path between the source and the destination and allocating a wavelength on all the links of the path. The selection of the path and wavelength is an important optimization problem and is known as the routing and wavelength assignment (RWA) problem [1].
\nIn WDM optical networks, transparent optical cross‐connects (OXCs) are used in order to provide efficient space and wavelength switching functions [2]. An OXC takes as input signals at multiple wavelengths and some of these wavelengths can be dropped locally, while others pass through by switching them to the appropriate output ports. For the implementation of OXCs, wavelength selective switch (WSS) technology is used for the deployment of cost‐effective and dynamic wavelength‐switched networks [3].
\nIn transparent optical networks, where data signals remain in the optical domain until they reach their destinations, connections are vulnerable to physical layer attacks. An attack is defined as an intentional action against the ideal and secure functioning of the network. One type of attack in optical networks is high‐power jamming which can affect the signal through in‐band jamming that is the result of intra‐channel crosstalk or out‐of‐band jamming that is the result of inter‐channel crosstalk and nonlinearities [4]. This type of attack propagates through the transparent network affecting several connections, and as a consequence, the localization of this kind of attack is a difficult problem. Due to the high bit rates of optical networks and the interaction of the connections, a jamming attack can potentially cause a huge amount of information loss. Therefore, the limitation of attack propagation is a crucial consideration in optical network planning. An overview of security challenges in communication networks can be found in Ref. [5].
\nPhysical layer attacks in optical networks have been studied by several researchers [6–10]. In these works, the concept of attack‐aware routing and wavelength assignment (Aa‐RWA) is analyzed. Specifically, in Ref. [6], authors proposed an integer linear program (ILP) formulation and a tabu search heuristic algorithm for the routing sub‐problem in optical networks in order to minimize the effect of out‐of‐band jamming and the gain competition caused in optical fibers and optical amplifiers, respectively. In Ref. [7], authors proposed ILP formulation and heuristic algorithms for the wavelength assignment sub‐problem in optical networks in order to minimize the in‐band jamming attack caused in optical nodes. In Ref. [8], authors proposed ILP and heuristic algorithms based on simulated annealing techniques in order to minimize the in‐band and out‐of‐band jamming attacks. Moreover, in Ref. [9, 10], authors proposed a greedy randomized adaptive search procedure (GRASP) heuristic and an ILP formulation, respectively, for the placement of power equalizers in order to limit the jamming attack propagation in transparent optical networks.
\nAnother important aspect in network planning that usually is not taken into account is the uncertainty of the connection requests. In most cases, the demands are considered to be known before network planning; however, in some cases, network planning must be performed for a period of time where the demand requests can only be forecasted with uncertainty. One approach to deal with demand uncertainty is by overprovisioning, essentially allocating many resources that can satisfy any traffic demand. However, this approach requires a high cost investment (capital expenditure—capex) from the network operators [11]. More sophisticated approaches to deal with demand uncertainty are necessary in order to achieve a cost‐effective network investment strategy [12].
\nStochastic programming (SP) [13] and robust optimization (RO) [14] are the main alternative techniques to deal with uncertain data both in a single period and in a multi‐period decision making process. In SP, the probability distribution functions of the underlying stochastic parameters must be known. On the other hand, RO addresses the uncertain nature of the problem without making specific assumptions on probability distributions. The uncertain parameters are assumed to belong to a deterministic uncertainty set. RO adopts an approach that addresses uncertainty by guaranteeing the feasibility and optimality of the solution against all instances of the parameters within the uncertainty set.
\nIn Ref. [15], authors apply robust optimization in order to incorporate the uncertainty of demands into the network upgrade problem. Under the robust network upgrade model, the network planning can be performed by tuning the trade‐off between network cost and robustness level. Further, in Ref. [16], authors propose multi‐period network planning approaches based on SP, where the demands are forecasted over periods of time and the network investments are performed based on these forecasts.
\nIn this chapter, novel Aa‐RWA algorithms are proposed to address the problem of multi‐period network planning under demand uncertainty with the objective to minimize the impact of possible physical layer attacks and at the same time to minimize the network infrastructure investment cost. Physical layer attacks are modeled as interactions among connections through in‐band and out‐of‐band channel crosstalk. Moreover, the investment cost is taken into account in this formulation via the number of WSSs required in order to minimize the impact of a possible physical layer attack.
\nThe simulation results show that when the distribution of demands for all the time periods is taken into account in advance, better results can be obtained in terms of the number of WSSs required to be placed in the network nodes so as to minimize the impact of a jamming attack, compared to the case where the distribution is known only for the period under consideration.
\nThe chapter is organized as follows. Section 2 describes the network architecture, while Section 3 describes the planning approaches for demand uncertainty. In Section 4, the physical layer attacks in optical networks are presented, and in Section 5, the problem of attack‐aware RWA with given traffic demands is solved. This is followed in Section 6 by the attack‐aware RWA under demand uncertainties. Performance results are presented in Section 7, while Section 8 presents some concluding remarks.
\nAn optical network topology is represented by a connected graph
BS‐based nodes (Figure 1) include a splitter first stage (1 × N) that implicitly provides a broadcast capability toward all outputs. In a BS‐based architecture, the WSS functionality (second stage) resembles a multiplexer (it switches each individual wavelength to a certain output). Although this is a simple and popular architecture, the loss introduced by the power splitters limits its scalability and can only be utilized in network nodes with small degrees.
\nBroadcast‐and‐select‐based node architecture.
RS architecture nodes (Figure 2) on the other hand have a WSS first stage (1 × N) that provides on‐demand routing to the required output. The basic advantage of the RS‐based architecture with respect to the BS‐based architecture is that the through loss is not dependent on the degree of the node. However, it requires additional WSSs at the input stage, which makes it more costly to be implemented.
\nRoute‐and‐select‐based node architecture.
Both implementations have a WSS second stage (N × 1) that provides the selection of the wavelengths at the output fibers, allowing full switching flexibility (any wavelength from any incoming fiber can pass through or any wavelength from the add/drop terminals can be added/dropped).
\nIn order to deal with the losses introduced by the power splitters of the BS‐based architecture and the high cost of the RS‐based architecture, a hybrid architecture can also be used (Figure 3). This architecture contains either splitters (1 × N) or WSSs (1 × N) at the input ports as can be seen in Figure 3. In essence, hybrid nodes are constructed by replacing splitters with WSSs at the input stage of the BS‐based nodes.
\nHybrid node architecture.
Depending on the network traffic, it is envisioned that a fraction of the network nodes will be BS‐based, other nodes will be RS‐based and the rest will be hybrid nodes. The objective of the proposed algorithms of this chapter is to use hybrid nodes in order to minimize the lightpath interactions and at the same time to minimize the network cost. This means that WSSs are placed only in some of the input ports and specifically only at the locations that are necessary in order to allow only the necessary wavelengths to pass through the WSS and avoid all crosstalk interactions. Thus, by using hybrid nodes and not RS‐based nodes, we can minimize the network cost while at the same time eliminating crosstalk interactions and consequently protecting the network against jamming attacks.
\nIn order to provide cost‐efficient network solutions, it is necessary to plan optical networks over a long‐time horizon. When dealing with optical networks, where the cost to build the network is high and the investment that takes place should last for a long time, sophisticated planning decisions must take place to ensure that the network infrastructure will not require any major upgrades over a predetermined amount of time. The problem becomes more involved in the case of future traffic demand forecasts that include uncertainty, as network planning decisions must be taken without the exact knowledge of future traffic demands. In this case, these decisions will be based on estimations. In the remaining of this chapter, the proposed multi‐period network planning approaches with uncertain traffic demands are discussed. The planning approaches assume that for the first period, the demands follow a known distribution and for the periods that follow the demands are increased based on a multiplicative factor.
\nThe multi‐period network planning problem in this chapter will be investigated for two different period‐planning types as detailed below.
\nThis approach considers the demands of the next period and optimizes the investment cost in each period. Therefore, the solution is calculated sequentially for each period. The solution can be optimal for each period but not jointly for all the periods under consideration. Once the solution is provided for one period, then this solution affects the solution of the periods that follow. This is due to the fact that the solution of one period is assumed to be fixed and the solutions of the periods that follow are now based upon the previously found solutions.
\nThis approach considers the demands of all periods and optimizes the investment cost from the beginning of the planning period, that is the multi‐period approach minimizes the network cost over all periods at once. Therefore, the demand distribution for every time period is necessary. This approach can calculate an optimal overall solution and provide decisions for the investment strategy of network operators.
\nIn general, the physical layer attacks in transparent optical networks can be grouped in two main categories: eavesdropping and service disruption.
\nIn eavesdropping, the purpose of an attacker is to passively analyze the traffic in the network after gaining access to the information through an unauthorized observation method. To gain mid‐span access to the fiber, the eavesdropper has to cut through and strip away the cable’s outer jacket to access the individual fibers in its center.
\nService disruption can be performed through high‐power jamming attacks and can be classified into three sub‐categories based on the effects it inflicts on the signal:
\nin‐band jamming which is the result of intra‐channel crosstalk,
out‐of‐band jamming that is the result of inter‐channel crosstalk and nonlinearities, and
gain competition in optical amplifiers, where a high‐power jamming signal can increase its own power, thus resulting in reduction in the gain of the rest of the co‐propagating channels on the same fiber.
These types of attacks propagate through the transparent network affecting several connections, and as a consequence, the localization of an attack is a difficult problem. Due to the high bit rates of optical networks and the interaction of the connections, a jamming attack can cause a huge amount of information loss. Therefore, the limitation of attack propagation is a crucial consideration in designing transparent WDM optical networks.
\nThe focus of this study is to deal with service disruption and especially with in‐band and out‐of‐band jamming attacks.
\nHigh‐power in‐band jamming attack is an attack that can be performed through the intra‐channel crosstalk effect. Intra‐channel crosstalk is the effect of power leakage between lightpaths crossing the same switch and using the same wavelength due to non‐ideal isolation of the inputs/output ports of the switching fabric. Intra‐channel crosstalk cannot be filtered out, since the interfering signal is on the same wavelength as the one affected. Thus, a high‐power jamming signal can cause significant leakage inside the switches between lightpaths that are on the same wavelength as the attacking signal.
\nFigure 4 illustrates an example of a high‐power jamming attack in node
High‐power in‐band jamming attack propagation.
High power out‐of‐band jamming attack is an attack that can be performed through the inter‐channel crosstalk effect. Inter‐channel crosstalk results due to the power leakage between adjacent channels.
\nFigure 5 illustrates the high‐power out‐of‐band signal propagation through the inter‐channel crosstalk effect. In this case, lightpath (
High‐power out‐of‐band jamming attack propagation.
In this section, a heuristic algorithm is presented for the Aa‐RWA with given demands in order to minimize the propagation of physical layer attacks. The algorithm aims at minimizing the interactions among lightpaths in order to avoid the propagation of high‐power jamming attacks, in terms of affected lightpaths through intra‐ and inter‐channel crosstalk. As discussed above, with these types of attacks, an affected lightpath can also affect other lightpaths, thus spreading the attack to other parts of the network. The goal of the Aa‐RWA techniques is then to minimize as much as possible the spread of any attack that can occur in the network.
\nThe proposed heuristic approach solves the problem by sequentially serving one‐by‐one the connections and consists of two phases. In the first phase,
In the first phase,
This section describes the heuristic algorithm for establishing the connections, one‐by‐one, in some particular order with the objective to minimize the lightpath interactions through the crosstalk effect.
\nEach link
Each path
Thus, the element
The aim of the heuristic algorithm is to establish
The wavelength utilization
After establishing the lightpath (
As emphasized above, multi‐period network planning is crucial in avoiding overprovisioning WSSs within hybrid nodes. As such, the aforementioned Aa‐RWA algorithm is extended in this section to consider the demand forecasts of future time periods and in doing so to ensure that the WSS placement considers the changing network characteristics. In line with the most popular period‐planning types available in the literature, the Aa‐RWA algorithm is applied for both the incremental network planning case as well as the multi‐period planning approach. In the former case, the Aa‐RWA algorithm is applied in each step, the WSS placement for that step is decided, and the subsequent period considers the presence of those WSSs in the network when running the Aa‐RWA algorithm for the next time period. In the multi‐period approach on the other hand, the in‐band and out‐of‐band interactions in each node are calculated for all time periods by the Aa‐RWA algorithm and then statistical measures are used to assess the level of interaction and the extent to which a WSS is needed at a specific node.
\nIn either case, the level of in‐band and out‐of‐band interactions (and the subsequent decision on WSS placement) is strongly governed by the demand uncertainties and the assumptions made on growth year after year. The growth factor is assumed to be the mean value around a normally distributed random variable of the actual traffic growth between source destination pairs and thus Monte Carlo simulations are conducted to investigate the overall performance under independent trials. Details of the network setup and the exact values considered are detailed in Section 7.
\nIn incremental Aa‐RWA network planning, there is knowledge for the demand distribution for only one period at a time (the period under consideration). For this reason, decisions are taken only for the current period. The flowchart of the proposed algorithm is given in Figure 6. The algorithm takes as input
A flowchart of the incremental Aa‐RWA algorithm.
In multi‐period Aa‐RWA network planning, there is a priori knowledge for the demand distribution for all the time periods under consideration. Therefore, decisions are taken based on the traffic estimate for all time periods. The flowchart of the proposed algorithm is given in Figure 7. The algorithm takes as input
A flowchart of the multi-period Aa‐RWA algorithm.
The network topology used in our simulations was the Geant‐2 network topology [17] that has 34 nodes and 54 bidirectional links (108 fibers; shown in Figure 8). Each fiber is able to support 80 wavelengths. The capacity of each wavelength was assumed equal to 10 Gbps. Initially, 50 different traffic matrices were produced with uniform distribution between source destination pairs and mean value equal to 1.35 Tbs of total requested capacity. Both algorithms (multi‐period Aa‐RWA and incremental Aa‐RWA) were studied for five periods. The growth factor for each period was assumed to be equal to 1.5. The demand increase for each period applies for the source destination pairs that have a non‐zero value at the initial traffic matrix. The algorithms for each source destination pair computed
Geant‐2 network topology: 34 nodes, 54 links.
In Figure 9, results for the multi‐period Aa‐RWA algorithm are depicted. Specifically, in Figures 9(a), (b), the mean values for inter‐channel and intra‐channel crosstalk for a horizon of five periods are presented, respectively. The mean values are the result of the 50 different traffic matrices. The inter‐channel and intra‐channel crosstalk per link (input port of a node) are the number of the interactions at this port. In Figure 9, the central mark of each box is the median, and the edges of the box are the 25th and 75th percentiles, the whiskers extend to the most extreme data points that are not considered outliers, and outliers are plotted individually.
\nMean values of multi‐period Aa‐RWA algorithm for (a) inter‐channel crosstalk and (b) intra‐channel crosstalk for a horizon of five periods.
Both inter‐ and intra‐channel crosstalk increase exponentially with increasing traffic demands. However, as shown in Figures 9(a), (b), specific links experience significantly higher crosstalk than others. Therefore, the required WSSs can be placed only at the input ports of the nodes that experience high crosstalk.
\nIncremental Aa‐RWA algorithm follows the same trend as the multi‐period Aa‐RWA algorithm (as illustrated in Figure 10). Note that the trend would be completely different in the case where an attack‐unaware RWA algorithm was used. In that case, all the periods would experience high values of crosstalk as can be found from the results of [8]. These results are not presented here, since the scope of this chapter is to plan an optical network in order to deal with physical layer attacks and therefore an attack‐unaware RWA algorithm is out of the scope of this study.
\nMean values of incremental Aa‐RWA algorithm for (a) inter‐channel crosstalk and (b) intra‐channel crosstalk for a horizon of five periods.
In Figure 11, the mean value of inter‐ and intra‐channel crosstalk that the links experience during time period 5 is presented for the multi‐period Aa‐RWA algorithm. The results are presented in the form of histograms, where each column represents the number of links that have crosstalk between the ranges that are depicted in the x‐axis of the histograms. From Figure 11, it is clear that a very small number of links have very high crosstalk, while the majority of links experience only a small crosstalk effect. This result offers a good indication that an addition of a small number of WSSs at the specific nodes where high crosstalk is experienced will significantly improve the performance of the network, thus minimizing the effect of a jamming attack. Note that the larger the number of links that appear in the leftmost bar, the smaller the crosstalk effect at the input ports of these nodes. Therefore, the best algorithms will be those where their histograms are more left shifted.
\nHistogram for link (input ports of nodes) distribution related to (a) inter‐channel and (b) intra‐channel crosstalk interactions for multi‐period Aa‐RWA algorithm for the fifth period.
In Figure 12, the same histograms are presented for the case of the incremental Aa‐RWA algorithm. Compared to the previous results of the multi‐period case, the crosstalk effect of the incremental updating results to slightly increased inter‐channel crosstalk and comparable intra‐channel crosstalk. Nevertheless, the same crosstalk trends are observed here as well, where a small number of links experience significant crosstalk, while the rest of the links experience significantly lower crosstalk.
\nHistogram for link (input ports of nodes) distribution related to (a) inter‐channel and (b) intra‐channel crosstalk interactions for incremental Aa‐RWA algorithm for the fifth period.
In Figure 13, the total number of required WSSs in order to minimize the impact of crosstalk effect per period is presented for the two proposed algorithms. For each period, the algorithms decide to place a WSS at the input port of a link when the mean values of the inter‐ and intra‐channel crosstalk are above a certain threshold. Based on these decisions, the multi‐period Aa‐RWA algorithm requires less number of WSSs per period as compared to the incremental Aa‐RWA algorithm. This is due to the fact the routing and wavelength assignment of the multi‐period algorithm takes into account the future traffic demands, and the decisions are more appropriate. On the other hand, the incremental algorithm may decide to place a WSS in one period, and in future periods, there will be demands that would not be able to be established over already placed WSSs due to insufficient number of wavelengths. Thus, there would be not enough choices for efficient routing and wavelength assignment.
\nNumber of required WSSs per period for the incremental Aa‐RWA and the multi-period Aa‐RWA algorithms.
This chapter proposed new attack‐aware RWA algorithms for the multi‐period planning of optical networks under demand uncertainty. These algorithms decide on the placement of wavelength selective switches at the input ports of network nodes and the period that the placement should be performed. The decisions are taken based on the distribution of the demands with the objective to minimize the impact of physical layer attacks over all periods. The algorithm that takes into account jointly all the time periods has a better performance than the algorithm that takes into account the periods in a sequential manner, resulting in a smaller number of required WSSs to be placed in the network so as to minimize the effect of a jamming attack.
\nThis chapter is based upon work from COST Action CA15127 (”Resilient communication services protecting end user applications from disaster‐based failures: RECODIS”) supported by COST (European Cooperation in Science and Technology). This work has received funding from the People Program (Marie Curie Actions) of the European Union’s Seventh Framework Program (FP7/2007–2013) under REA Grant Agreement n° 630853.
\nObesity is excess body weight for a given height, defined by a body mass index (BMI) ≥ 30 kg/m2. In some Asian countries (e.g., Japan), the threshold to define obesity is lower (25 kg/m2). Obesity is a major health problem worldwide associated with increased morbidity/mortality and high cost for the society. The prevalence of obesity has doubled in more than 70 countries since 1980. The number of adult subjects with obesity is around 700 million worldwide. Nearly 4 million subjects die each year from the consequences of obesity. The annual cost of obesity is more than $2 trillion [1, 2, 3].
Management of obesity requires multidisciplinary approaches including diet, food supplement, exercise, behavior change, drug, medical device, gut microbiome manipulation, and surgery [1, 4, 5, 6, 7, 8, 9]. The annual obesity treatment market is around $6 billion. In the USA, among subjects with obesity, only 2% receive drug therapy and less than 1% who are eligible for bariatric surgery benefits from it. The reasons for these undertreatment rates are mainly related to adverse effects/complications and cost of drugs and bariatric surgery.
Medical devices available 100 years ago were limited to stethoscope, original medical X-ray imaging device, and electrocardiograph [10]. Over the past several decades, the number of medical devices has increased exponentially. Anti-obesity medical devices are positioned to bridge the gap between more conservative treatments (e.g., lifestyle) and more aggressive interventions (e.g., bariatric surgery). Compared to bariatric surgery, they have the advantage of being less invasive, easier to perform, and reversible. Anti-obesity medical devices are available upon prescription or as over-the-counter products.
Anti-obesity medical devices represent a heterogeneous family of devices in terms of presentation, usage/administration, mechanism of action, effectiveness, safety, regulation, availability, and cost [8, 11, 12, 13, 14]. The devices can be as different as an intragastric balloon, a stomach aspiration system, or particles administered orally in capsule.
Unlike anti-obesity drugs that act chemically through specific receptors, anti-obesity medical devices act rather mechanically. They do not have systemic absorption, specific metabolism, or receptors. Their research and development pattern follow specific models. The terminology used for medical devices differs slightly from that used for drugs (e.g., sham instead of placebo, effectiveness instead of efficacy). With some medical devices, it is not possible to use a sham for ethical and/or technical reasons. Compared to drugs, medical devices have different effectiveness dynamics. Unlike drugs, for some anti-obesity medical devices, there is no compliance issue with the device use since the device is placed in the body for several months and there is no need for repeated administration that might be affected by the subject’s discipline. Because there is no systemic absorption, there are no side effects related to the impact of medical devices on different organs through the bloodstream. The regulatory systems ruling anti-obesity medical devices are based on short product life cycles. The marketing and sales of anti-obesity medical devices are based on different models as compared to drugs.
Anti-obesity medical devices can cause weight loss through different mechanisms by acting at different levels.
Although the primary impact of the anti-obesity medical devices is mechanical, the final effect may be achieved through changes in several factors controlling appetite and food intake, especially the gastrointestinal hormones (e.g., decrease in ghrelin, increase in glucagon-like peptide-1).
An anti-obesity medical device can decrease the food intake by limiting the bite size in the oral cavity.
An anti-obesity medical device can decrease the food intake by reducing the available stomach volume.
Other levels of impact to achieve food intake reduction are possible and have been or will be investigated.
An anti-obesity medical device can decrease the amount of available nutrient by removing part of the gastric contents.
An anti-obesity medical device can decrease the absorbed nutrient by bypassing part of the intestine.
The main challenges in the development of anti-obesity medical devices are due to lack of unique regulatory guidance and disparities in time and cost of approval processes in different countries.
The regulation of anti-obesity medical devices varies by countries or group of countries. There are important differences in the regulatory processes, cost, and time to approval between the USA and Europe [15].
Over-the-counter anti-obesity medical devices may or may not need regulation and approval/clearance depending on the devices and countries.
In the USA, the regulation of medical devices is centralized since 1976 through the FDA. This centralized process allows a better coordination and enforcement of rules. The CDRH is in charge of approval/clearance of anti-obesity medical devices. There are three regulatory classes of medical devices: Class I (low risk), Class II (moderate risk), and Class III (high risk). Based on the expected weight loss, two categories of anti-obesity medical devices have been defined: weight-loss devices (“more” weight loss) and weight-management devices (“less” weight loss). The approval/clearance is through premarket notification process [510(k)] or premarket approval (PMA) process and is based on safety and effectiveness.
A new guidance using benefit-risk approaches is in preparation by the CDRH taking into account the weight loss (extent and duration), the rate of responders (≥ 5% weight loss), the reduction of comorbidities (e.g., hypertension, dyslipidemia, type 2 diabetes), and the safety [rate and severity of adverse events (AEs)].
Since its formation in 1993, the European Union (EU), currently a group of 27 countries (after the recent removal of the United Kingdom), has established rules for the approval of medical devices. Anti-obesity medical devices are regulated under directive 93/42/EC. There are four regulatory classes of medical devices: Class I (low risk), Class IIa (low-moderate risk), Class IIb (moderate-high risk), and Class III (high risk). Each member country has a regulatory entity called Competent Authority (CA). The CA certifies/notifies entities called Notified Bodies (NBs) in each country. The NBs are private, for-profit companies responsible for conformity assessment and CE (Conformité Européenne) mark. There are over 50 NBs in the EU. The NBs contract with the manufacturers to supply the CE mark and the approval is based on safety and performance. Clinical effectiveness is not a requirement. An anti-obesity medical device with a CE mark can be marketed in any EU member country.
In the EU, the approval process is more flexible, faster, and less expensive in comparison to the USA.
Other countries have different regulatory procedures. The approval process has varying degrees of sophistication and challenges. In Japan for example, the application is processed by the Pharmaceutical and Medical Device Agency (PMDA). Although the Japanese market is very attractive for foreign manufacturers, the approval process is complicated, long, and expensive due to multiple factors (e.g., lack of translated documents from Japanese, need to perform specific and costly studies in the Japanese population).
Several countries accept the FDA approval/clearance or the CE mark.
Several anti-obesity medical devices have been approved/cleared in the USA, in the EU, and in other countries. Some devices have been approved first in the EU before being approved several years later in the USA. This section focuses on anti-obesity medical devices regulated in the USA.
Below are the anti-obesity medical devices approved/cleared in the USA (Table 1). Their use should always be in conjunction with lifestyle recommendations on diet and exercise.
Lap-Band® (BioEnterics Corporation) is an adjustable silicone band placed laparoscopically around the proximal stomach immediately below the gastro-esophageal junction and attached to a subcutaneous reservoir (Figure 1). The level of pressure is adjusted by varying the amount of fluid that is inserted into the band. The technique is reversible, has low procedural risk, and can be performed in an outpatient setting. Lap-Band® can be revised and/or replaced as needed. The pressure imposed to the proximal stomach causes early satiety and a decrease in food intake with subsequent weight loss [8].
Lap-Band® (BioEnterics Corporation—Picture downloaded from the internet).
In the pivotal study, 292 subjects (247 females, 45 males, mean BMI = 47.4 kg/m2) were implanted with Lap-Band® and had follow-up evaluations for 36 months. The primary effectiveness endpoint, assessed in the per protocol population at Month 36, was the excess weight loss. Safety analysis also included an additional seven subjects who previously received a similar device. At Month 36, the excess weight loss was 36.2%, relatively stable over the previous 18 months (the weight loss was 18.0%). AEs were observed in 266 subjects (89.0%). Most AEs were of gastrointestinal origin (mainly nausea/vomiting, gastroesophageal reflux, and abdominal pain, mild in the majority of cases). Serious AEs (SAEs) were observed in 16 subjects (5.4%), mainly port leakage and 2 deaths (unrelated to device).
Overall, Lap-Band® is relatively safe and has a strong effectiveness. The device was approved by the FDA in June 2001. It is indicated for weight loss in severe obesity with BMI ≥ 40 kg/m2 or obesity with BMI ≥ 35 kg/m2 in the presence of one or more severe comorbidities, in conjunction with lifestyle recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, inflammatory diseases of the gastrointestinal tract, upper gastrointestinal bleeding conditions, portal hypertension, and severe cardiopulmonary diseases (non-exhaustive list). Complications include proximal gastric enlargement, erosion or migration of the band, and leaks of the band system (non-exhaustive list).
Orbera™ Intragastric Balloon System (Apollo Endosurgery, Inc.) is a balloon made of silicone placed endoscopically in the stomach (Figure 2). The balloon is filled with saline mixed with methylene blue (450–700 mL). The methylene blue is a marker for balloon dysfunction. In case of balloon rupture, the methylene blue will be systematically absorbed and change the color of urine to blue. The procedure is minimally invasive and can be performed in an outpatient setting. The balloon is removed endoscopically after 6 months. By occupying gastric volume, Orbera™ Intragastric Balloon System causes early satiety and a decrease in food intake with subsequent weight loss [8, 11, 13, 14].
Orbera™ Intragastric Balloon System (Apollo Endosurgery, Inc.—Picture downloaded from the internet).
In the pivotal study, 255 subjects (229 females, 26 males, mean BMI = 35.3 kg/m2) were randomized into Orbera™ Intragastric Balloon System (n = 125) or control (no intragastric intervention, n = 130) arms for 6 months and 6 months follow-up after Orbera™ Intragastric Balloon System removal. Safety analysis also included an additional 35 run-in, non-randomized subjects who received Orbera™ Intragastric Balloon System. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the modified intention-to-treat (mITT) population at Month 9, were the excess weight loss in Orbera™ Intragastric Balloon System arm and a significantly greater weight loss in Orbera™ Intragastric Balloon System arm compared to control arm. At Month 9, the excess weight loss was 26.5% in Orbera™ Intragastric Balloon System arm, and the weight losses were 9.1 and 3.4% in Orbera™ Intragastric Balloon System and control arms, respectively. The study did not meet the first co-primary effectiveness endpoint but met the second co-primary effectiveness endpoint. At Month 6, the weight losses were 10.2 and 3.3% in Orbera™ Intragastric Balloon System and control arms, respectively. A total of 810 device-related AEs was observed (mainly nausea/vomiting, gastroesophageal reflux, and abdominal pain, mild or moderate in the majority of cases). Fourteen device- or procedure-related SAEs were observed, mainly device intolerance but no death.
Overall, Orbera™ Intragastric Balloon System is relatively safe and has a strong effectiveness. The device was approved by the FDA in August 2015. It is indicated for weight loss in obesity with BMI between 30 and 40 kg/m2, in conjunction with lifestyle recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, prior bariatric surgery, inflammatory diseases of the gastrointestinal tract, upper gastrointestinal bleeding conditions, and liver deficiency (non-exhaustive list). Complications include balloon migration, intestinal obstruction, gastric ulcer, and gastric perforation (non-exhaustive list).
Obalon Balloon System (Obalon Therapeutics, Inc.) is a swallowable balloon made of nylon and polyethylene contained within a gelatin capsule (attached to a thin inflation catheter) that is taken orally. The correct position of the capsule is confirmed with fluoroscopy. The capsule disintegrates in the stomach and releases the balloon. The balloon is filled with air (250 cc of nitrogen and sulfur hexafluoride gas mixture). Up to three balloons can be placed in the same session or sequentially over a 6-month period (Figure 3). The procedure is minimally invasive and can be performed in an outpatient setting without endoscopy. The balloon is removed endoscopically after 6 months. By occupying gastric volume, Obalon Balloon System causes early satiety and a decrease in food intake with subsequent weight loss [8, 13, 14].
Obalon Balloon System (Obalon Therapeutics, Inc.—Picture downloaded from the internet).
In the pivotal study, 387 subjects (341 females, 46 males, mean BMI = 35.2 kg/m2) were randomized into Obalon Balloon System (n = 198) or control (sham capsule, n = 189) arms for 6 months. At Month 6, the eligible control arm subjects were permitted to crossover and receive Obalon Balloon System for 6 months. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the mITT population at Month 6, were a significantly greater weight loss in Obalon Balloon System arm compared to control arm (super-superiority) and the responder rate at 5% weight loss in Obalon Balloon System arm. Device-related safety analysis also included 138 subjects who switched at Month 6 from control to Obalon Balloon System. At Month 6, the weight losses were 6.6 and 3.4% in Obalon Balloon System and control arms, respectively, and the responder rate at 5% weight loss in Obalon Balloon System arm was 62.1%. The study met both co-primary effectiveness endpoints. Most device-related AEs were of gastrointestinal origin (mainly abdominal pain and nausea/vomiting, mild in the majority of cases), observed in 300 subjects (89.3%). Device- or procedure-related SAEs were observed in one subject (0.3%), a case of peptic ulcer disease.
Overall, Obalon Balloon System is relatively safe and has a modest effectiveness. The device was approved by the FDA in September 2016. It is indicated for weight loss in obesity with BMI between 30 and 40 kg/m2, in conjunction with lifestyle recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, prior bariatric surgery, inflammatory diseases of the gastrointestinal tract, gastric diseases, and eating disorders (non-exhaustive list). Complications include balloon migration, intestinal obstruction, gastric ulcer, and gastric perforation (non-exhaustive list).
TransPyloric Shuttle (BAROnova, Inc.) is a device placed endoscopically in the stomach (Figure 4). It is not strictly a balloon but functions like a balloon. It has two asymmetrical bulbs made of silicone connected by a flexible catheter. The procedure is minimally invasive and can be performed in an outpatient setting. The shuttle is removed endoscopically after 12 months. By creating intermittent obstruction to gastric outflow that delays gastric emptying, TransPyloric Shuttle causes early satiety and a decrease in food intake with subsequent weight loss [8, 13].
TransPyloric Shuttle (BAROnova, Inc.—Picture downloaded from the internet).
In the pivotal study, 270 subjects (252 females, 18 males, mean BMI = 36.6 kg/m2) were randomized into TransPyloric Shuttle (n = 181) or control (sham endoscopic procedure, n = 89) arms for 12 months. The TransPyloric Shuttle was successfully placed in 171 subjects. The study also included an additional 32 open-label subjects who received TransPyloric Shuttle. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the per protocol population at Month 12, were a significantly greater weight loss in TransPyloric Shuttle arm compared to control arm and the responder rate at 5% weight loss in TransPyloric Shuttle arm. At Month 12, the weight losses were 9.5 and 2.8% in TransPyloric Shuttle and control arms, respectively, and the responder rate at 5% weight loss in TransPyloric Shuttle arm was 66.8%. The study met both co-primary effectiveness endpoints. Most device-related AEs were of gastrointestinal origin (mainly nausea/vomiting, abdominal pain, and dyspepsia, mild or moderate in the majority of cases), observed in 200 subjects (98.5%). Device- or procedure-related SAEs were observed in six subjects (3.0%), mainly device impaction but no death.
Overall, TransPyloric Shuttle is relatively safe and has a strong effectiveness. The device was approved by the FDA in April 2019. It is indicated for weight loss in obesity with BMI between 35 and 40 kg/m2 or obesity with BMI between 30 and < 35 kg/m2 in the presence of one or more comorbidities, in conjunction with lifestyle recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, prior bariatric surgery, inflammatory diseases of the gastrointestinal tract, gastric diseases, and eating disorders (non-exhaustive list). Complications include device impaction and gastric ulcer (non-exhaustive list).
AspireAssist® (Aspire Bariatrics, Inc.) is a device attached to a percutaneous endoscopic gastrostomy tube implanted endoscopically (Figure 5). It allows the aspiration of gastric contents 20–30 minutes after each major meal (a meal containing more than 200 calories). Thorough chewing of food is required to facilitate aspiration with the 6-mm-diameter tube. The procedure is minimally invasive and can be performed in an outpatient setting. The device is removed when the desired body weight is reached. By allowing the removal of approximately 30% of ingested calories over 5–10 minutes, AspireAssist® causes decreased absorption of gastrointestinal nutrients with subsequent weight loss [8, 11, 12, 13, 14].
AspireAssist® (Aspire Bariatrics, Inc.—Picture downloaded from the internet).
In the pivotal study, 171 subjects (149 females, 22 males, mean BMI = 41.6 kg/m2) were randomized into AspireAssist® (n = 111) or control (no intragastric intervention, n = 60) arms for 12 months. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the mITT population at Month 12, were a significantly greater excess weight loss in AspireAssist® arm compared to control arm (super-superiority) and the responder rate at 25% excess weight loss in AspireAssist® arm. At Month 12, the excess weight losses were 31.5 and 9.8% in AspireAssist® and control arms, respectively, and the responder rate at 25% excess weight loss in AspireAssist® arm was 56.8%. The study met the first co-primary effectiveness endpoint but not the second co-primary effectiveness endpoint. At Month 12, the weight losses were 12.1 and 3.6% in AspireAssist® and control arms, respectively. Device- or procedure-related AEs were observed in 93 subjects (83.8%, mainly peristomal granulation tissue, abdominal pain, and nausea/vomiting, mild in the majority of cases). Device- or procedure-related SAEs were observed in four subjects (3.6%), including peritonitis but no death.
Overall, AspireAssist® is relatively safe and has a strong effectiveness. The device was approved by the FDA in June 2016. It is indicated for weight loss in obesity with BMI between 35 and 55 kg/m2, in conjunction with lifestyle recommendations, in subjects who failed to respond to non-surgical weight-loss therapy. It is contraindicated in several conditions including pregnancy, non-adult subjects, upper gastrointestinal bleeding conditions, chronic abdominal pain, severe cardiopulmonary diseases, and eating disorders (non-exhaustive list). Complications include skin irritation, infection, and electrolyte abnormalities (non-exhaustive list).
SmartByte Device (Scientific Intake) is an oral device occupying space on the upper palate. It includes a temperature-recording sensor to monitor usage (Figure 6). It is worn in mouth during meal consumption. The device is renewed every 12 months. By creating limited bite size and slower eating, SmartByte Device causes a decrease in food intake with subsequent weight loss [16].
SmartByte Device (Scientific Intake—Picture downloaded from the internet).
In the pivotal study, 173 subjects (BMI between 26 and 36 kg/m2) were randomized into SmartByte Device (n = 102) or control (no oral intervention, n = 71) arms for 4 months. All subjects were given lifestyle recommendations. The primary effectiveness endpoint, assessed in the ITT population at Month 4, was a greater responder rate at 5% weight loss in SmartByte Device arm compared to control arm. At Month 4, the responder rates at 5% weight loss were 20.6 and 5.6% in SmartByte Device and control arms, respectively. The study did not meet the primary effectiveness endpoint. At Month 4, the weight losses were 1.7 and 0.4% in SmartByte Device and control arms, respectively. Device-related AEs were observed in five subjects (4.9%, including two episodes of transient choking on food). No device-related SAEs were observed.
Overall, SmartByte Device is safe and has a weak effectiveness. The device was cleared by the FDA in May 2017. It is indicated to aid in weight management in overweight and obesity with BMI between 27 and 35 kg/m2, in conjunction with lifestyle recommendations. It is contraindicated in pregnancy and eating disorders. Complications include choking on food and mouth soreness (non-exhaustive list).
Plenity™ (Gelesis, Inc.) is a superabsorbent hydrogel (cellulose and citric acid, forming a three-dimensional matrix) administered orally in capsules with 500 mL of water (three capsules, 20–30 minutes before lunch and dinner). The hydrogel particles hydrate up to 100 times their initial weight in the stomach and intestine (Figure 7). The particles mix with ingested food and create a larger volume with higher elasticity and viscosity. The particles degrade in the colon and are eliminated in the feces. By creating a larger volume with higher elasticity in the stomach and intestine, Plenity™ causes early satiety and a decrease in food intake with subsequent weight loss [17].
Plenity™ (Gelesis, Inc.—Picture downloaded from the internet).
In the pivotal study, 436 subjects (245 females, 191 males, mean BMI = 33.8 kg/m2) were randomized into Plenity™ (n = 223) or control (sham capsule, n = 213) arms for 6 months. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the ITT population (multiple imputation) at Month 6, were a significantly greater weight loss in Plenity™ arm compared to control arm (super-superiority) and the responder rate at 5% weight loss in Plenity™ arm. At Month 6, the weight losses were 6.4 and 4.4% in Plenity™ and control arms, respectively, and the responder rate at 5% weight loss in Plenity™ arm was 58.6%. The study did not meet the first co-primary effectiveness endpoint but met the second co-primary effectiveness endpoint. Most device-related AEs were of gastrointestinal origin (mainly abdominal distension, diarrhea, infrequent bowel movements, and flatulence, mild in the majority of cases), observed in 84 subjects (37.7%). No device-related SAEs were observed.
Overall, Plenity™ is safe and has a modest effectiveness. The device was cleared by the FDA in April 2019. It is indicated to aid in weight management in overweight and obesity with BMI between 25 and 40 kg/m2, in conjunction with lifestyle recommendations. It is contraindicated in pregnancy, non-adult subjects, and history of allergic reaction to the components of Plenity™ capsule. No relevant complications have been reported.
Comparative effectiveness of the above anti-obesity medical devices is reported in Table 2.
Medical device | Approval date | Indication |
---|---|---|
Lap-Band® | June 5, 2001 | Weight-loss device (BMI ≥ 35 kg/m2) |
Orbera™ Intragastric Balloon System | August 5, 2015 | Weight-loss device (BMI 30–40 kg/m2) |
AspireAssist® | June 14, 2016 | Weight-loss device (BMI 35–55 kg/m2) |
Obalon Balloon System | September 8, 2016 | Weight-loss device (BMI 30–40 kg/m2) |
SmartByte Device | May 18, 2017 | Weight-management device (BMI 27–35 kg/m2) |
Plenity™ | April 12, 2019 | Weight-management device (BMI 25–40 kg/m2) |
TransPyloric Shuttle | April 16, 2019 | Weight-loss device (BMI 30–40 kg/m2) |
Approved/cleared anti-obesity medical devices in the USA ranked by approval date.
Medical device | Treatment duration | Total body weight loss |
---|---|---|
Lap-Band® | 36 months | 18.0% |
AspireAssist® | 12 months | 12.1% |
Orbera™ Intragastric Balloon System | 6 months | 10.2% |
TransPyloric Shuttle | 12 months | 9.5% |
Obalon Balloon System | 6 months | 6.6% |
Plenity™ | 6 months | 6.4% |
SmartByte Device | 4 months | 1.7% |
Approved/cleared anti-obesity medical devices in the USA ranked by extent of total body weight loss in pivotal studies.
Relevant complications (non-exhaustive list), some being very rare, of the above anti-obesity medical devices are reported in Table 3.
Medical device | Treatment duration | Relevant complication |
---|---|---|
Lap-Band® | 36 months | Proximal gastric enlargement, band erosion or migration, system leaks |
AspireAssist® | 12 months | Skin irritation, infection, electrolyte abnormalities |
Orbera™ Intragastric Balloon System | 6 months | Balloon migration, intestinal obstruction, gastric ulcer, gastric perforation |
TransPyloric Shuttle | 12 months | Device impaction, gastric ulcer |
Obalon Balloon System | 6 months | Balloon migration, intestinal obstruction, gastric ulcer, gastric perforation |
Plenity™ | 6 months | None |
SmartByte Device | 4 months | Choking on food, mouth soreness |
Relevant complications of the approved/cleared anti-obesity medical devices in the USA in pivotal studies.
Cost of the above anti-obesity medical devices is reported in Table 4.
Medical device | Average cost (Range) |
---|---|
Lap-Band® | $15,000 ($10,000–$30,000) |
AspireAssist® | $10,000 ($7,000–$13,000) |
Orbera™ Intragastric Balloon System | $6,000 ($3,000–$9,000) |
TransPyloric Shuttle | To be determined |
Obalon Balloon System | $8,000 ($6,000–$9,000) |
Plenity™ | $100/month |
SmartByte Device | $500 |
Cost of the approved/cleared anti-obesity medical devices in the USA.
Several anti-obesity medical devices have been withdrawn by the manufacturers from the market in the USA after approval by the FDA (e.g., Maestro Rechargeable System, Realize Adjustable Gastric Band, ReShape Integrated Dual Balloon System, Garren Gastric Bubble).
Several anti-obesity medical devices are currently in development in different countries (e.g., Epitomee Device [18]).
EndoBarrier® has obtained a CE mark in the EU but its approval in the USA has been challenged for safety reasons [8, 11, 12, 13, 14].
A variety of anti-obesity medical devices are available as over-the-counter products (e.g., NozNoz, slow control fork, slipper genie).
Anti-obesity medical devices represent a heterogenous family of devices in terms of presentation, usage/administration, mechanism of action, effectiveness, safety, regulation, availability, and cost. They offer an attractive approach in managing obesity. Anti-obesity medical devices are positioned to bridge the gap between more conservative treatments (e.g., lifestyle) and more aggressive interventions (e.g., bariatric surgery). Their use should always be combined with lifestyle changes.
Considering the large market size of obesity treatment and the small percentage of subjects treated with drugs or bariatric surgery, anti-obesity medical devices can play a major role in the management of obesity.
The author received honorarium for consultancy from Gelesis, Inc.
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This will pose serious problems with food, water and energy supply, particularly in less-developed countries. Considering that the human pressure over natural resources has already reached critical levels, international agencies such as the World Bank and UN Food and Agriculture Organization (FAO) are soliciting scientific research in order to identify innovative solutions to support the primary sector. Nanotechnology is a rapidly evolving field with the potential to take forward the agriculture and food industry with new tools which promise to increase food production in a sustainable manner and to protect crops from pests. Such expectations are coupled with some uncertainties about the fate of nanomaterials in the agro-environment. However, the field application of engineered nanomaterials (ENMs) has not been properly investigated yet, and many aspects have only been considered theoretically or with models, which make it difficult to properly assess the usefulness of ENMs for plant fertilization and protection.",book:{id:"6763",slug:"new-visions-in-plant-science",title:"New Visions in Plant Science",fullTitle:"New Visions in Plant Science"},signatures:"Luca Marchiol",authors:[{id:"163884",title:"Prof.",name:"Luca",middleName:null,surname:"Marchiol",slug:"luca-marchiol",fullName:"Luca Marchiol"}]},{id:"67311",doi:"10.5772/intechopen.86341",title:"Wheat Production in India: Trends and Prospects",slug:"wheat-production-in-india-trends-and-prospects",totalDownloads:2364,totalCrossrefCites:27,totalDimensionsCites:39,abstract:"Trends in Indian wheat production before and after the inception of the All India Coordinated Research Project (AICRP) on wheat have been analyzed to show its significant progress over the years. 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Miscellaneous neglected and underutilized grain legumes (MNUGLs) are crops primarily characterized by inherent features and capabilities to withstand the effects of abiotic stress and climate change, significantly replenish the soil, as well as boost food and protein security. This chapter provides insight into the benefits of MNUGLs as food and nutritional security climate smart crops, capable of growing on marginal lands. Exploring and improving MNUGLs depend on a number of factors among which are concerted research efforts, cultivation and production, as well as utilization awareness across global populace geared toward reawakening the interest on the abandoned legumes. The emergence of the clustered regularly interspaced short palindromic repeat (CRISPR/cas9) technology combined with marker-assisted selection (MAS) offers great opportunities to improve MNUGLs for sustainable utilization. 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As such, crops which are the main food source must be produced at a higher pace in order to cater in tandem with the food demand. In the past, traditional plant breeders practice classical breeding techniques to propagate plants with desirable traits. However, traditional breeding technique lies in that only individuals of the same or closely related species can be crossbred. Moreover, traditional breeders will not be able to obtain traits which are not inherent within the gene pool of their target plants through classical breeding. With recent advancements in the field of genetic engineering, it is now possible to insert beneficial genes from a completely different species or even kingdom into a target plant, yielding transgenic plants with multiple ideal traits. To develop a transgenic plant, parameters such as vector constructions, transformation methods, transgene integration, and inheritance of transgene need to be carefully considered to ensure the success of the transformation event. Hence, this chapter aimed to provide an overview of transgenic plants’ development, its advantages and disadvantages, as well as its application for the betterment of mankind.",book:{id:"6763",slug:"new-visions-in-plant-science",title:"New Visions in Plant Science",fullTitle:"New Visions in Plant Science"},signatures:"Lee-Yoon Low, Shun-Kai Yang, De-Xian Andrew Kok, Janna Ong-\nAbdullah, Ngai-Paing Tan and Kok-Song Lai",authors:[{id:"195386",title:"BSc.",name:"Shun Kai",middleName:null,surname:"Yang",slug:"shun-kai-yang",fullName:"Shun Kai Yang"},{id:"221544",title:"Dr.",name:"Kok-Song",middleName:null,surname:"Lai",slug:"kok-song-lai",fullName:"Kok-Song Lai"},{id:"240035",title:"Ms.",name:"Lee Yoon",middleName:null,surname:"Low",slug:"lee-yoon-low",fullName:"Lee Yoon Low"},{id:"240036",title:"Mr.",name:"Kok",middleName:null,surname:"Andrew-De-Xian",slug:"kok-andrew-de-xian",fullName:"Kok Andrew-De-Xian"},{id:"257891",title:"Dr.",name:"Janna Ong",middleName:null,surname:"Abdullah",slug:"janna-ong-abdullah",fullName:"Janna Ong Abdullah"},{id:"257892",title:"Dr.",name:"Ngai Paing",middleName:null,surname:"Tan",slug:"ngai-paing-tan",fullName:"Ngai Paing Tan"}]},{id:"67311",title:"Wheat Production in India: Trends and Prospects",slug:"wheat-production-in-india-trends-and-prospects",totalDownloads:2364,totalCrossrefCites:27,totalDimensionsCites:39,abstract:"Trends in Indian wheat production before and after the inception of the All India Coordinated Research Project (AICRP) on wheat have been analyzed to show its significant progress over the years. A brief intercountry comparison of productivity, production and area coupled with regional comparison within India has been attempted to give an idea about the contribution of country and regions, respectively, for global and national food security. The milestones in Indian wheat programme and research outcomes were highlighted post-AICRP along with the vision and strategies set for 2050 against diverse production challenges. Regional disparities, zone-wise production constraints and research programmes for achieving the set production target were briefed. The chapter concludes with possible interventions in strengthening the complete wheat value chain for ensuring food security for the future generation.",book:{id:"8168",slug:"recent-advances-in-grain-crops-research",title:"Recent Advances in Grain Crops Research",fullTitle:"Recent Advances in Grain Crops Research"},signatures:"Sendhil Ramadas, T.M. 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Therefore, a full understanding of plant-NP interaction and phytotoxicological mechanism is required for accurate risk assessment to ensure the safe use of nanoparticle. A range of analytical techniques have been developed to detect and characterize the uptake, translocation, cellular internalization and intracellular biotransformation of nanoparticles in plants. Imaging methodologies, including various electron microscopy, spectrometry-based techniques, together with ICP-based techniques such as ICP-OES, ICP-MS and SP-ICP-MS, have been widely used to obtain information about NPs size, morphology, size distribution, cellular localization, elemental speciation, mass concentration and so on. Due to the complexity of biological samples to be analyzed, these techniques are often combined accordingly to provide complementary information regarding plant-NP interaction. This review provides an introduction to the most widely used techniques in the study of interactions between plants and nanoparticles. 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