This article is more than 5 years old. Information may no longer be current.
FDA approves left atrial appendage closure device
Click Here to Manage Email Alerts
Boston Scientific Corporation announced that the FDA has approved the Watchman left atrial appendage closure device.
The device is intended to serve as an alternative to warfarin for the reduction of thromboembolism risk in the left atrial appendage among patients with nonvalvular atrial fibrillation who are at high risk for stroke and systemic embolism, according to a press release. The device functions by closing the left atrial appendage in order to prevent blood clots from migrating.
The approval was based on results from the Watchman clinical program, which included data from more than 2,400 patients over approximately 6,000 patient-years of follow-up. Favorable results from trials including PROTECT AF and PREVAIL suggested that the device was a safe and effective alternative to warfarin. In December 2011, the FDA Circulatory System Devices Panel voted 13-1 that the benefits of the Watchman device outweighed its potential risks.
A second vote in October 2014 resulted in a split: panelists voted 12-0 that the device was safe, 6-7 that it was not effective and 6-5 that its benefits outweighed its risks. However, the panel reached a consensus that the device should only be considered a second-line therapy for certain patients.
With this approval, the device is indicated for patients who are deemed suitable for warfarin but have "an appropriate rationale to seek a non-pharmacologic alternative," according to the release.
Vivek Y. Reddy
"We know that up to 40% of patients who are eligible for oral anticoagulation do not take it for numerous reasons, highlighting the need for additional treatment options," Vivek Y. Reddy, MD, director of the cardiac arrhythmia service at Mount Sinai Medical Center, who served as co-principal investigator of the PROTECT AF and PREVAIL trials, said in the release. "The Watchman device is a breakthrough treatment providing those patients who are suitable for warfarin with an implant-based alternative to long-term warfarin therapy while still reducing the risk of stroke."
The device has been available internationally since 2009. Following this approval, it will be available at U.S. centers that participated in the clinical trial program, and will later be introduced into other specialized facilities as physicians receive training for its implantation, according to the release.