The Food and Drug Administration has approved Boston Scientific’s Watchman, a device designed to reduce strokes in patients with non-valvular atrial fibrillation.
The device has been available in markets outside the U.S. since 2009, but two previous attempts to get it approved in the U.S. were unsuccessful.
FDA’s Circulatory System Devices Advisory Panel last October recommended that the FDA approve the device, voting 6-5 (with one abstention) that the Watchman’s benefits outweigh the risks. In 2009 the panel split on whether the device should be approved, and in 2013 it approved the device, yet the FDA declined to approve the device and asked for more data before granting approval.
The parachute-shaped device is implanted in the left atrial appendage of the heart—the source for about nine out of every 10 strokes via a catheter. It acts as a filter preventing thrombi from traveling toward the brain.
According to Boston Scientific, the device is indicated for patients who are eligible to use warfarin, but have had trouble tolerating the drug and are seeking an alternative to long-term warfarin therapy.
"The Watchman device is an important step forward in stroke management for patients with AF," said Vivek Reddy, MD., Director of the Cardiac Arrhythmia Service at the Mount Sinai Medical Center and co-principal investigator of the clinical trials involving Watchman. "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. 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."