Saleem Nasir, Xu Shuai
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.
Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Dig Dis Sci. 2016 Aug;61(8):2165-2174. doi: 10.1007/s10620-016-4117-2. Epub 2016 Mar 22.
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.
医疗设备是消化道疾病诊断和治疗中的关键组成部分。通过挖掘美国食品药品监督管理局数据库，获取了2000年至2014年期间通过上市前批准（PMA）途径进行的高风险医疗设备研发情况。在此期间，总共仅有九种胃肠道（GI）设备获得批准。此外，只有一种GI设备获得了加速审评。导致批准的临床研究大多限于非盲法、非随机研究。只有少数关键研究明确并达到了其主要终点（27%）。九种设备中有八种需要进行上市后研究。最终，在所研究的时间段内，心脏病学领域的获批总数为157项。在各个医学和外科专业中，GI领域排名第12，占PMA批准总数的比例不到2%。未来的工作应侧重于推动该领域更多的高风险设备创新。
