US FDA perspective on regulatory issues affecting circulatory assist devices.
There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.
Sapirstein
Wolf
W
Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US FDA, Rockville, MD 20850, USA. wys@cdrh.fda.gov
Chen
Eric
E
Swain
Julie
J
Zuckerman
Bram
B
D018795:Device Approval; D017408:Guidelines as Topic; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration