title: Overview of High-Risk Medical Device Innovation in Gastroenterology from 2000 to 2014: Enhancing the Pipeline.
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.
authors.affiliation: Department of Internal Medicine, Presence Saint Joseph Hospital in Affiliation with University of Illinois College of Medicine, 2900 N. Lake Shore Dr., Chicago, IL, 60657, USA. nasirsaleemmd@gmail.com.
authors.forename: Nasir
authors.identifier: http://orcid.org/0000-0001-6831-2674
authors.initials: N
authors.lastname: Saleem
authors.affiliation: Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Shuai
authors.initials: S
authors.lastname: Xu
mesh_terms: D050110:Bariatric Surgery / Q000295:instrumentation*; D016208:Databases, Factual; D018795:Device Approval; D004864:Equipment and Supplies; D005242:Fecal Incontinence / Q000628:therapy; D042882:Gallstones / Q000628:therapy; D005762:Gastroenterology; D005764:Gastroesophageal Reflux / Q000628:therapy; D006801:Humans; D062069:Inventions; D008096:Lithotripsy / Q000295:instrumentation*; D009765:Obesity / Q000601:surgery; D061848:Optical Imaging / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration
keywords: Device approval; FDA; Gastroenterology; Medical devices