Boston Scientific’s Watchman FLX Pro LAAC Device Receives FDA Approval

September 6, 2023—Boston Scientific Corporation announced it has received FDA approval for the latest-generation Watchman FLX Pro left atrial appendage closure (LAAC) device.

Boston Scientific stated that the Watchman FLX Pro device is built upon the proven safety and procedural performance of the Watchman FLX LAAC device, which was approved in July 2020.

According to the company, the new device is designed to advance the procedural performance and safety of the Watchman technology, which is indicated to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy.

The Watchman FLX Pro device is enhanced with a polymer coating, visualization markers, and a broader size matrix to treat a wider range of patients. The company outlined these features as follows:

• The coating is designed to reduce device-related thrombus and enable faster, controlled healing and endothelization of the device surface.
• The newly added visualization markers are intended to enhance device placement for optimal sealing around the LAA.
• The new 40-mm size option will enable physicians to treat a broader range of anatomies with the Watchman technology.

Boston Scientific stated that preclinical research for the new technology has shown positive results for faster, more controlled healing around the device surface. Data across several of these preclinical studies demonstrated that the polymer coating provided an 86% reduction in inflammation at 3 days after the procedure; a 70% reduction of thrombus at 14 days; and a 50% increase in endothelial tissue coverage at 45 days post procedure.

The Watchman FLX Pro device maintains key characteristics of the Watchman FLX device, including a fully rounded design that enables physicians to safely enter and maneuver within the left atrial appendage. It can also be fully recaptured, repositioned, and redeployed for precise placement. The frame design allows for optimal device engagement with the tissue for long-term stability and a faster, more complete seal, noted the company.

Finally, the company advised that the Watchman FLX Pro device is currently being studied in the WATCHMAN FLX Pro CT study, which is a single-center premarket study using multiple imaging modalities to assess postprocedural device tissue coverage and the relationship, if any, to clinical outcomes. It will be further evaluated in the postmarket HEAL-LAA study, which will commence over the coming weeks and follow outcomes from approximately 1,000 patients with NVAF implanted with the technology at 60 sites in the United States.

Kenneth Stein, MD, senior Vice President and Global Chief Medical Officer, Boston Scientific, commented in the company’s press release, “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 gives promise for a future with less thrombosis risk, which may eventually enable a simpler postimplant drug regimen for patients.”