FDA Update: WATCHMAN FLX Pro Left Atrial Appendage Closure Device Receives FDA Approval
The U.S. Food and Drug Administration (FDA) has approved the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device, the latest WATCHMAN device designed to reduce stroke risk in patients with non-valvular atrial fibrillation who require an alternative to oral anticoagulation, according to a Boston Scientific press release.
The WATCHMAN FLX Pro device includes several enhancements to the previous WATCHMAN FLX device design, which received FDA approval in July 2020, such as a thromboresistant coating, visualization markers and a larger size option, enabling clinicians to treat patients with larger left atrial appendages.
Results from several preclinical studies found that the polymer coating of the device "provided an 86% reduction in inflammation three days following the procedure, a 70% reduction of thrombus at 14 days and a 50% increase in endothelial tissue coverage 45 days post procedure."
For more details, access the company press release.
Keywords: United States Food and Drug Administration, ACC Advocacy, Polymers, Atrial Fibrillation, Thrombosis, Anticoagulants, Inflammation
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