Don’t Have a Stroke: Boston Scientific’s WATCHMAN Gains FDA Approval

Boston Scientific Corporation has achieved a significant milestone with the FDA's recent approval of the WATCHMAN FLX ProTM Left Atrial Appendage Closure (LAAC) Device. This cutting-edge technology represents the latest evolution in the WATCHMAN series and is designed to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) who require an alternative to oral anticoagulation therapy.

The WATCHMAN FLX Pro device builds upon the success of its predecessor, the WATCHMAN FLXTM LAAC device, which received certification in July 2020 and has been utilized in approximately 190,000 procedures worldwide out of the 300,000 WATCHMAN procedures conducted thus far. The key advancements include a polymer coating, visualization markers, and an expanded matrix, allowing for the treatment of a broader range of patients.

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One of the most notable improvements is the introduction of a polymer coating on the device's surface, which facilitates faster healing and endothelization, reducing the risk of device-related thrombus formation. Furthermore, visualization markers have been incorporated to enhance precise device placement for sealing the left atrial appendage (LAA). With an increased size of 40mm, physicians can now employ WATCHMAN technology on a wider range of anatomies, providing more patients with this life-saving solution.

Joe Fitzgerald, the Group President of Cardiology at Boston Scientific, expressed enthusiasm about these advancements, emphasizing how they will enhance post-procedural healing, implant precision, and the range of treatable appendage sizes. Dr. Kenneth Stein, the Senior Vice President and Global Chief Medical Officer, highlighted the potential for reduced thrombosis risk and simplified post-implant drug regimens thanks to the innovative polymer coating.

The WATCHMAN FLX Pro device's rounded form allows for safe access and maneuverability within the left atrial appendage. It is designed for full retrieval, repositioning, and redeployment,. ensuring precise placement. The frame design optimizes interaction with the surrounding tissue for long-term stability and a swifter, more complete closure.

To further validate the device's efficacy, a single-center premarket study is underway, evaluating post-procedural device tissue coverage and its correlation with clinical outcomes. Additionally, the post-market HEAL-LAA trial will monitor 1,000 NVAF patients implanted with the device across 60 U.S. sites in the coming weeks.

This latest accomplishment serves as a reminder of Boston Scientific's commitment to advancing global health through cutting-edge medical solutions. With over 40 years of experience as a global medical technology pioneer, the company continues to address unmet patient needs and lower healthcare costs.

This innovative device represents a testament to Boston Scientific's commitment to revolutionizing healthcare through cutting-edge medical solutions.