Boston Scientific’s Watchman FLX left atrial appendage closure (LAAC) device is a safe, effective treatment option for patients with nonvalvular atrial fibrillation (AFib), according to new 2-year data presented at TVT 2021.
The Pinnacle FLX trial, which included 400 patients from the United States with nonvalvular AFib, was designed to assess the Watchman FLX device’s potential as an alternative to long-term oral anticoagulation therapy. This latest analysis represented an update after researchers had previously shared promising 12-month results.
Saibal Kar, MD, the trial’s co-principal investigator and an interventional cardiologist at Los Robles Regional Medical Center, presented his team’s findings July 21. Overall, the group found, the device achieved a rate of ischemic stroke or systemic embolism of 3.4%--much lower than the initial performance goal of 8.7%. Also, no cases of device embolization or pericardial effusion requiring cardiac surgery were reported.
“These findings demonstrate sustained device performance over two years and reinforce the excellent safety and efficacy profile of the Watchman FLX technology,” Kar said in a prepared statement. “Building upon the low complication rates and 100% rate of effective LAA closure seen at 12 months, the 3.4% rate of ischemic stroke and systemic embolism at 24 months is very encouraging in this complex, elderly patient population.”
“The final results of this pivotal study underscore how design advancements of the Watchman FLX device—which allow for improved anchoring, a faster, more effective left atrial appendage closure and compatibility with more complex anatomies—have translated into a safe, effective and durable option for patients with nonvalvular AFib at increased risk for stroke and systemic embolism and an appropriate rationale to seek a non-pharmaceutical alternative," added Ian Meredith, AM, Boston Scientific’s global chief medical officer.
More information on TVT 2021, including details on how to access full presentations, is available here.
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.