Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center of University of Southern California, Los Angeles, California, USA.
Heart and Vascular Center, Dartmouth Health, Lebanon, New Hampshire, USA.
Catheter Cardiovasc Interv. 2024 Jul;104(1):84-91. doi: 10.1002/ccd.31053. Epub 2024 Apr 19.
Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.
心血管设备对于治疗心血管疾病至关重要，包括脑血管、冠状动脉、瓣膜、先天性、周围血管和心律失常疾病。然而，在每个产品的生命周期中，实际应用中的血管设备的监管和监测都带来了挑战。四个例子说明了最近在实际应用中使用的经过 FDA 批准的设备在安全性、合理使用和疗效方面出现的安全、适当使用和疗效方面出现的挑战和问题。我们概述了提供者、监管者和支付者如何提供高质量的心血管护理、识别安全信号、确保设备公平获得以及研究实际应用中设备潜在问题的潜在途径。
