Left Atrial Appendage Closure Studies: FDA Offers Tips
This article was originally published in The Gray Sheet
Executive Summary
The clinical path toward FDA approval of a left atrial appendage closure system for preventing stroke in atrial fibrillation patients has not been simple so far, informing the agency’s current expectations.
You may also be interested in...
Will Watchman Prevail With FDA? Boston Scientific’s LAA Closure Trial Raises Questions, Controversy
The PREVAIL study of Boston Scientific’s Watchman left atrial appendage (LAA) closure device was primarily positive, but will it be enough to win FDA approval for the device?
Boston Scientific Says PREVAIL Results Affirm Safety of Watchman LAA Anti-Stroke Device
Inexperienced users had similar results as experienced operators in the PREVAIL trial of Boston Scientific’s Watchman left-atrial appendage closure device. FDA asked the company to conduct the trial after results of the PROTECT AF trial left doubts about the device’s safety and steep learning curve.
Boston Scientific Says PREVAIL Results Affirm Safety of Watchman LAA Anti-Stroke Device
Inexperienced users had similar results as experienced operators in the PREVAIL trial of Boston Scientific’s Watchman left-atrial appendage closure device. FDA asked the company to conduct the trial after results of the PROTECT AF trial left doubts about the device’s safety and steep learning curve.