Following the first implants of metallic stents into coronary arteries more than 3 decades ago, iterations in coronary stent technology have been rapidly progressive. However, before they are introduced into clinical practice, new coronary stents undergo a sequence of testing to establish safety and efficacy. This typically consists of extensive bench testing and preclinical evaluations, first-in-man and smaller (typically prospective observational) studies with surrogate end points, and finally a randomized clinical trial against established comparator devices. If a device can sufficiently generate evidence of safety and efficacy through that testing sequence, regulatory bodies will then typically approve the device conditional on performance of postmarket surveillance.
Kirtane AJ, Mehran R. When Can Strut Thickness Really Matter in Percutaneous Coronary Intervention? JAMA Cardiol. Published online May 21, 2019. doi:10.1001/jamacardio.2019.1902
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