nach oben

Digestive Diseases and Sciences

Erschienen in:

22.03.2016 | Review

Overview of High-Risk Medical Device Innovation in Gastroenterology from 2000 to 2014: Enhancing the Pipeline

verfasst von: Nasir Saleem, Shuai Xu

Erschienen in: Digestive Diseases and Sciences | Ausgabe 8/2016

Einloggen, um Zugang zu erhalten

Abstract

Medical devices are a critical component in the diagnosis and treatment of diseases of the alimentary tract. The United States Food and Drug Administration database was mined for high-risk medical device development via the pre-market approval (PMA) pathway from 2000 to 2014. In total, there were only nine GI (gastrointestinal) devices approved during this period. Furthermore, only one GI device was granted expedited review. The clinical studies leading to approval were mostly limited to non-blinded, non-randomized studies. Only a minority of pivotal studies defined and met their primary endpoints (27 %). Eight out of nine devices were required to undergo post-marketing studies. Ultimately, cardiology led with 157 total approvals in the time period studied. GI ranked 12 out of 18 across various medical and surgical specialties and accounted for <2 % of total PMA approvals. Future efforts should focus on spurring more high-risk device innovation in the field.

Visiongain. Gastrointestinal Devices: World Market 2013–2023; 2013.

Guha K, Sharma R. The era of modern medicine: implants and all. Frontline Gastroenterol. 2012;3:84–85.CrossRef

Corbett GBP, Pugh P, et al. Endoscopy and implantable electronic devices. Frontline Gastroenterol.. 2012;3:72–75.CrossRef

Curfman GD, Redberg RF. Medical devices—balancing regulation and innovation. N Engl J Med. 2011;365:975–977.CrossRefPubMed

Krucoff MW, Brindis RG, Hodgson PK, Mack MJ, Holmes DR Jr. Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective. JACC Cardiovasc Interv. 2012;5:790–796.CrossRefPubMed

Avorn J, Kesselheim AS. The 21st century cures act—will it take us back in time? N Engl J Med. 2015;372:2473–2475.CrossRefPubMed

Premarket approval (PMA) database Rockville, MD: FDA; 2015 [updated 1/5/2014]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.

Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. BMJ. 1999;318:593–596.CrossRefPubMedPubMedCentral

Sorenson C, Drummond M. Improving medical device regulation: the United States and Europe in perspective. Milibank Q.. 2014;92:114–150.CrossRef

10.

Heneghan C, Langton D, Thompson M. Ongoing problems with metal-on-metal hip implants. BMJ. 2012;344:e1349.CrossRefPubMed

11.

FDA. Should take steps to ensure that high-risk device types are approved through the most stringent premarket review process. In: Office USGA, ed. 2009: 1–53.

12.

Medical devices and the public’s health: the FDA 510(k) clearance process at 35 years. In: Medicine Io, ed. 2011.

13.

Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979–2012. JAMA. 2014;311:385–391.CrossRefPubMedPubMedCentral

14.

Rome BN, Kramer DB, Kesselheim AS. Approval of high-risk medical devices in the US: implications for clinical cardiology. Curr Cardiol Rep. 2014;16:489.CrossRefPubMedPubMedCentral

15.

Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European union? A systematic review. PLoS Med. 2012;9:e1001276.CrossRefPubMedPubMedCentral

16.

Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302:2679–2685.CrossRefPubMed

17.

Nieuwenhuijse MJ, Nelissen RGHH, Schoones JW, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ. 2014;349:g5133.CrossRefPubMedPubMedCentral

18.

Graf W, Mellgren A, Matzel KE, et al. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011;377:997–1003.CrossRefPubMed

19.

Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011;4:165–171.CrossRefPubMed

20.

Zannad F, Stough WG, Pina IL, et al. Current challenges for clinical trials of cardiovascular medical devices. Int J Cardiol. 2014;175:30–37.CrossRefPubMed

21.

Hall RF. Hearing on “impact of medical device regulation on jobs and patients”. US House of Representatives Energy and Commerce Subcommittee on Health [Internet]. 2011:1–14.

22.

Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009;136:376–386.CrossRefPubMed

23.

Peery AF, Dellon ES, Lund J, et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012;143:e3.CrossRef

24.

Mensah GA, Brown DW. An overview of cardiovascular disease burden in the United States. Health Aff (Millwood). 2007;26:38–48.CrossRef

25.

Wong WD, Congliosi SM, Spencer MP, et al. The safety and efficacy of the artificial bowel sphincter for fecal incontinence: results from a multicenter cohort study. Dis Colon Rectum. 2002;45:1139–1153.CrossRefPubMed

26.

Rutala WA, Weber DJ. Gastrointestinal endoscopes: a need to shift from disinfection to sterilization? JAMA. 2014;312:1405–1406.CrossRefPubMed

27.

FDA. Learn if a medical device has been cleared by FDA for marketing [cited 2015 5/25]. http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm.

28.

Xu S, Kesselheim AS. Medical innovation then and now: perspectives of innovators responsible for transformative drugs. J Law Med Ethics. 2014;42:564–575.CrossRefPubMed

29.

Santos IC, Gazelle GS, Rocha LA, Tavares JM. Medical device specificities: opportunities for a dedicated product development methodology. Expert Rev Med Devices. 2012;9:299–311.CrossRefPubMed

30.

Santos IC, Tavares JM. Additional peculiarities of medical devices that should be considered in their development process. Expert Rev Med Devices. 2013;10:411–420.CrossRefPubMed

31.

Santos IC, Gazelle GS, Rocha LA, Tavares JM. Modeling of the medical device development process. Expert Rev Med Devices. 2012;9:537–543.CrossRefPubMed

32.

Nimgaonkar A, Yock PG, Brinton TJ, Krummel T, Pasricha PJ. Gastroenterology and biodesign: contributing to the future of our specialty. Gastroenterology. 2013;144:258–262.CrossRefPubMed

33.

AGA. 2014 [cited 2015 5/27]. http://www.gastro.org/press_releases/2014/12/22/aga-s-gerd-registry-enrolls-first-patients.

34.

Laupland KB, Valiquette L. The dollars and sense of chronic hepatitis C infection management. Can J Infect Dis Med Microbiol. 2015;26:119–121.PubMedPubMedCentral

35.

Vanbiervliet G, Gonzalez J-M, Barthet M. Endoscopy innovations. Gastrointest Endosc. 2014;80:380–383.CrossRefPubMed

36.

Chamberlain RS, Sakpal SV. A comprehensive review of single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy. J Gastrointest Surg. 2009;13:1733–1740.CrossRefPubMed

37.

Kesselheim AS, Xu S, Avorn J. Clinicians’ contributions to the development of coronary artery stents: a qualitative study of transformative device innovation. PLoS ONE. 2014;9:e88664.CrossRefPubMedPubMedCentral

38.

Xu S, Avorn J, Kesselheim AS. Origins of medical innovation: the case of coronary artery stents. Circ Cardiovasc Qual Outcomes. 2012;5:743–749.CrossRefPubMed

Titel: Overview of High-Risk Medical Device Innovation in Gastroenterology from 2000 to 2014: Enhancing the Pipeline
verfasst von: Nasir Saleem
Shuai Xu
Publikationsdatum: 22.03.2016
Verlag: Springer US
Erschienen in: Digestive Diseases and Sciences / Ausgabe 8/2016
Print ISSN: 0163-2116
Elektronische ISSN: 1573-2568
DOI: https://doi.org/10.1007/s10620-016-4117-2

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

^{Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag}

Kostenlos registrieren

Neu im Fachgebiet Innere Medizin

Echinokokkose medikamentös behandeln oder operieren?

06.05.2024 DCK 2024 Kongressbericht

Die Therapie von Echinokokkosen sollte immer in spezialisierten Zentren erfolgen. Eine symptomlose Echinokokkose kann – egal ob von Hunde- oder Fuchsbandwurm ausgelöst – konservativ erfolgen. Wenn eine Op. nötig ist, kann es sinnvoll sein, vorher Zysten zu leeren und zu desinfizieren.

Umsetzung der POMGAT-Leitlinie läuft

03.05.2024 DCK 2024 Kongressbericht

Seit November 2023 gibt es evidenzbasierte Empfehlungen zum perioperativen Management bei gastrointestinalen Tumoren (POMGAT) auf S3-Niveau. Vieles wird schon entsprechend der Empfehlungen durchgeführt. Wo es im Alltag noch hapert, zeigt eine Umfrage in einem Klinikverbund.

Proximale Humerusfraktur: Auch 100-Jährige operieren?

01.05.2024 DCK 2024 Kongressbericht

Mit dem demographischen Wandel versorgt auch die Chirurgie immer mehr betagte Menschen. Von Entwicklungen wie Fast-Track können auch ältere Menschen profitieren und bei proximaler Humerusfraktur können selbst manche 100-Jährige noch sicher operiert werden.

Die „Zehn Gebote“ des Endokarditis-Managements

30.04.2024 Endokarditis Leitlinie kompakt

Worauf kommt es beim Management von Personen mit infektiöser Endokarditis an? Eine Kardiologin und ein Kardiologe fassen die zehn wichtigsten Punkte der neuen ESC-Leitlinie zusammen.

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen

Springer Medizin

Abstract

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 8/2016

APOC3 rs2070666 Is Associated with the Hepatic Steatosis Independently of PNPLA3 rs738409 in Chinese Han Patients with Nonalcoholic Fatty Liver Diseases

Gastric Variceal Bleeding Caused by an Arterioportal Fistula Formation After TIPS and Related Complications

IVF in IBD: Initial Validation For Success?

GI-Safer Aspirin: Sometimes Sugar Coating Helps

Insulin Resistance as a Novel Risk Factor for Post-ERCP Pancreatitis: A Pilot Study