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.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: United States Food and Drug Administration, ACC Advocacy, Polymers, Atrial Fibrillation, Thrombosis, Anticoagulants, Inflammation

< Back to Listings