Today, Boston Scientific Corporation (NYSE: BSX) announced that it has received approval from the U.S. Food and Drug Administration for its latest-generation WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device. This innovative device is designed to enhance the performance and safety of the WATCHMAN technology, which is intended to reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) who require an alternative to oral anticoagulation therapy. The device now incorporates a polymer coating, visualization markers, and an expanded size matrix to cater to a broader range of patients.

The WATCHMAN FLX Pro device builds upon the established safety and procedural effectiveness of the WATCHMAN FLX™ LAAC device, which received approval in July 2020 and has been used in nearly 190,000 of the over 300,000 WATCHMAN procedures successfully conducted worldwide to date. The latest WATCHMAN FLX Pro device features a special coating designed to reduce the formation of device-related thrombus and promote faster, controlled healing and endothelization of the device surface. Additionally, new visualization markers have been incorporated to improve device placement for optimal sealing around the left atrial appendage (LAA). This device is also available in a new 40mm size option, enabling physicians to treat a wider range of anatomical variations with the WATCHMAN technology.

Joe Fitzgerald, group president of Cardiology at Boston Scientific, expressed enthusiasm, stating, "We are pleased to introduce our latest LAAC technology to U.S. clinicians. This technology is designed to enhance post-procedural healing, improve the precision of WATCHMAN FLX Pro implants, and expand the range of treatable appendages. These enhancements to our WATCHMAN FLX technology will enhance the efficiency of implant procedures and allow physicians to optimize treatment for their patients."

Preclinical research on this new technology has demonstrated positive outcomes, including faster, more controlled healing around the device surface. Data from several preclinical studies showed an 86% reduction in inflammation three days after the procedure, a 70% reduction in thrombus at 14 days, and a 50% increase in endothelial tissue coverage 45 days post-procedure.

Dr. Kenneth Stein, M.D., senior vice president and global chief medical officer at Boston Scientific, noted, "There is a rich history of safe use and low thrombosis rates in cardiovascular devices that utilize this thromboresistant polymer coating, and we have adapted that model to provide a more streamlined healing process that begins immediately following LAAC. We believe this evolution of the WATCHMAN device also holds promise for a future with less thrombosis risk, potentially enabling a simpler post-implant drug regimen for patients."

The WATCHMAN FLX Pro device retains key features of the WATCHMAN FLX device, including a fully rounded design for safe entry and maneuverability within the left atrial appendage. It can also be fully recaptured, repositioned, and redeployed for precise placement, and its frame design ensures optimal device engagement with the tissue for long-term stability and a faster, more complete seal.

The WATCHMAN FLX Pro device is currently undergoing evaluation in the WATCHMAN FLX Pro CT study, a single-center premarket study utilizing multiple imaging techniques to assess post-procedural device tissue coverage and its potential impact on clinical outcomes. Furthermore, it will be examined in the post-market HEAL-LAA study, which will commence in the coming weeks and follow outcomes for approximately 1,000 NVAF patients who have been implanted with the technology at 60 sites across the United States.

 

Source: prnewswire.com

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