Boston Scientific’s Watchman FLX device approved by FDA

Boston Scientific has received FDA approval for the latest-generation Watchman FLX Pro Left Atrial Appendage Closure Device. Designed to further advance the procedural performance and safety of the WATCHMAN technology, which is indicated to reduce stroke risk in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy, the device now features a polymer coating, visualization markers and a broader size matrix to treat a wider range of patients. Data across several preclinical studies demonstrated that the polymer coating 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.