Boston Scientific receives FDA approval for latest generation Watchman…
Boston Scientific has gained approval from the U.S. Food and Drug Administration for the latest iteration of their Watchman FLX Pro Left Atrial Appendage Closure (LAAC) device.
This advanced device is designed to enhance the procedural safety and effectiveness of the Watchman technology, specifically for patients with non-valvular atrial fibrillation (NVAF) who require an alternative to oral anticoagulation therapy to reduce the risk of stroke. The latest version of the device incorporates a polymer coating, visual markers, and an expanded size range, enabling treatment for a broader spectrum of patients.
The Watchman FLX Pro builds upon the proven safety and performance of its predecessor, the Watchman FLX LAAC device, which received approval in July 2020 and has been used in nearly 190,000 out of the over 300,000 successful Watchman procedures conducted worldwide to date. The latest iteration of the Watchman FLX Pro features a coating designed to reduce device-related clot formation and promote quicker, controlled healing and tissue coverage on the device's surface. Additionally, new visual markers have been added to facilitate precise device placement for effective sealing around the left atrial appendage (LAA). This new version also introduces a 40mm size option, enabling physicians to treat a wider range of anatomies with the Watchman technology.
Joe Fitzgerald, group president, cardiology, Boston Scientific, said: "We are pleased to introduce U.S. clinicians to our newest LAAC technology, which is designed to enhance post-procedural healing, improve the precision of Watchman FLX Pro implants, and expand the size range of treatable appendages. These enhancements to our Watchman FLX technology will enable efficiency during implant procedures and allow physicians to optimise treatment for their patients."
Preclinical research on this new technology has yielded promising results, including faster, more controlled healing around the device surface. Data from several preclinical studies show an 86% reduction in inflammation three days post-procedure, a 70% reduction in clot formation at 14 days, and a 50% increase in tissue coverage of the device's surface at 45 days post-procedure.
Dr. Kenneth Stein, senior vice president and global chief medical officer, Boston Scientific, said: "There is a rich history of safe use and low thrombosis rates in cardiovascular devices that utilise 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 gives promise for a future with less thrombosis risk, which may eventually enable a simpler post-implant drug regimen for patients."
The Watchman FLX Pro device retains key features of the Watchman FLX, such as its fully rounded design for safe access and maneuverability within the left atrial appendage. It can also be fully retrieved, repositioned, and re-deployed for precise placement. Its frame design ensures optimal device engagement with tissue for long-term stability and a faster, more complete seal.
The Watchman FLX Pro device is currently under investigation in the Watchman FLX Pro CT study, a pre-market study conducted at a single center using various imaging techniques to evaluate post-procedural tissue coverage of the device and its potential impact on clinical outcomes. Additionally, it will undergo further assessment in the post-market HEAL-LAA study, commencing in the coming weeks, which will monitor outcomes in around 1,000 NVAF patients who have received the technology at 60 sites across the U.S.