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Confirmed: Watchman FLX LAAC device safe for nonvalvular AFib patients - Cardiovascular Business

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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.

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Confirmed: Watchman FLX LAAC device safe for nonvalvular AFib patients - Cardiovascular Business
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