Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia, USA.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1152-1158. doi: 10.1002/ccd.29730. Epub 2021 Apr 24.
Refractory angina is considered a devastating condition with limited medical and therapeutic options. The Neovasc Reducer device, when implanted in the coronary sinus, is designed to alleviate anginal symptoms. However, the available clinical data are sparse. The US Food and Drug Administration (FDA) assembled the Circulatory Systems Devices Panel to discuss the Reducer's safety and effectiveness. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we detail the deliberation and discussion among the circulatory panel members, including their final vote.
难治性心绞痛被认为是一种破坏性的疾病，其治疗方法有限。Neovasc Reducer 装置被设计用于缓解心绞痛症状，当植入冠状窦时。然而，现有的临床数据很少。美国食品和药物管理局 (FDA) 召集了循环系统设备小组来讨论 Reducer 的安全性和有效性。由于 2019 冠状病毒病大流行，这次会议是虚拟举行的。在本文中，我们详细介绍了循环系统小组成员的审议和讨论，包括他们的最终投票。
