Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN™ Left Atrial Appendage Closure Therapy

The WATCHMAN (Boston Scientific Corp, Maple Grove, MN) left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with non-valvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a “Not Approvable” letter was issued by the US Food and Drug Administration (FDA) based on safety concerns.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research