Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA 510(k) clearance for its Visual Ice cryoablation system. Visual Ice’s approval came just weeks after the FDA approved the company’s POLARx cryoablation system for treating paroxysmal AFib.
Watchman FLX Pro, the company’s latest left atrial appendage closure (LAAC) device, further advances Watchman’s performance and safety. It’s indicated for reducing stroke risk in patients with non-valvular AFib (NVAF) who need an alternative to oral anticoagulation therapy.
Boston Scientific designed its next-generation device with a polymer coating, visualization markers and a broader size matrix. The company says this design helps to treat a wider range of patients.
“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,” said Joe Fitzgerald, group president, Cardiology, Boston Scientific. “These enhancements to our Watchman FLX technology will enable efficiency during implant procedures and allow physicians to optimize treatment for their patients.”
More about the latest Boston Scientific Watchman technology
Marlborough, Massachusetts-based Boston Scientific says it built Watchman FLX Pro upon the performance of the original Watchman FLX. The company reported positive data for the previous-generation device as recently as May, with the FDA expanding its labeling in September 2022.
Watchman FLX originally received approval in July 2020. Doctors have used it in nearly 190,000 of the more than 300,000 Watchman procedures completed to date globally.
The new device maintains key characteristics of the previous one, including a fully rounded design for safe entry and maneuvering in the LAA. Doctors can fully recapture, reposition and redeploy the device for precise placement. Its frame enables optimal device engagement with tissue for long-term stability and a faster, more complete seal.
Boston Scientific’s latest design — enhanced with the new coating — reduces device-related thrombus. It also enables faster, controlled healing and endothelialization of the device surface. The company says newly added visualization markers enhance device placement for optimal sealing around the LAA. Boston Scientific also offers it in a new 40 mm size option, broadening the range of anatomies treatable by the device.
Backed by clinical data with more to come
Preclinical research demonstrated an 86% reduction in inflammation three days post-procedure, thanks to the polymer coating. Watchman FLX Pro also produced a 70% reduction of thrombus at 14 days. It led to a 50% increase in endothelial tissue coverage at 45 days after the procedure.
Boston Scientific says it currently has the Watchman FLX Pro CT study evaluating the new device. The single-center, premarket study uses multiple imaging modalities. It aims to assess post-procedural device tissue coverage and its relationship — if any — to clinical outcomes.
The company also plans to evaluate it further in the post-market HEAL-LAA study. It said it expects that study to commence in the coming weeks. HEAL-LAA follows approximately 1,000 patients with NVAF implated across 60 sites throughout the U.S.
“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,” said Dr. Kenneth Stein, SVP and global chief medical officer, Boston Scientific. “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.”
