The U.S. Food and Drug Administration (FDA) on March 13 approved the WATCHMAN Left Atrial Appendage (LAA) Closure Device, a first-of-its kind treatment that gives patients with non-valvular atrial fibrillation (AF) an alternative option to long-term warfarin therapy.

According to the device developer, Boston Scientific Corporation, Watchman is “indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS₂ or CHA₂DS₂-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.”

"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 PROTECT AF and PREVAIL studies. "We know that up to 40 percent 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."  

The PROTECT AF trial concluded that use of the watchman device for LAA ligation is feasible among patients with nonvalvular AF. The trial demonstrated a noninferior rate of cardiovascular death, stroke or systemic embolism, compared with warfarin alone, which was sustained to five years of follow-up. The PREVAIL trial found that percutaneous closure of the LAA is feasible in patients with AF. Compared with the PROTECT AF trial, there was improved procedural implant success with reduced device-related complications.

While Watchman was just approved for the U.S. market, 10,000 patients around the world have received the device and it is registered in 75 countries.

Now that Watchman has approved, the ACC will work with stakeholders to secure appropriate coverage of LAA closure.

Keywords: United States Food and Drug Administration, Device Approval, Atrial Appendage, Atrial Fibrillation

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