Boston Scientific receives new FDA approval for Stroke Reduction Device
New England Council member, Boston Scientific, has received approval from the U.S. Food and Drug Administration (FDA) for its WATCHMAN FLX™ Left Atrial Appendage Closure Device.
This groundbreaking technology is designed to further enhance the procedural performance and safety of the WATCHMAN system, which aims to reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) who seek an alternative to oral anticoagulation therapy. Built on the design of its predecessor, the WATCHMAN FLX Pro device introduces key features, including a polymer coating to reduce device-related thrombus, visualization markers for precise placement, and an expanded size matrix, allowing for a broader range of patients to be treated. Preclinical research has yielded encouraging results, with an 86% reduction in inflammation observed three days post-procedure, a 70% reduction in thrombus at 14 days, and a 50% increase in endothelial tissue coverage 45 days after the procedure.
“These enhancements to our WATCHMAN FLX technology will enable efficiency during implant procedures and allow physicians to optimize treatment for their patients,” Joe Fitzgerald, group president of Cardiology at Boston Scientific said in a statement.
The New England Council commends Boston Scientific for this advancement in atrial fibrillation treatment.
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