Boston Scientific claims FDA approval for latest Watchman heart plug implant

Boston Scientific has obtained an FDA green light for the latest version of its Watchman heart implant, designed to help lower the risk of stroke in patients with atrial fibrillation. 

Compared to its predecessor, the Watchman FLX Pro features a new polymer coating to assist in the natural healing process following the procedure. The updated implant also includes larger size options and additional visualization markers to aid clinicians in its placement.

Known as a left atrial appendage closure device, the Watchman is threaded through the blood vessels into the heart before expanding to fill a small pocket in the cardiac muscle wall. In people with afib, the most common irregular heartbeat, blood can pool in this appendage and form potentially dangerous clots that can exit the heart and become lodged in the brain or other organs.

The Watchman has previously been approved for people with non-valvular afib who need an alternative to blood thinner medications due to bleeding risks, with more than 300,000 procedures completed to date, the company said.

Boston Scientific also received an approval in September 2022 that expanded the range of drug regimens that can be prescribed in the weeks after implantation, allowing physicians to choose 45 days of dual antiplatelet therapy instead of oral anticoagulants plus aspirin for the same time period.

The FLX Pro’s new polymer layer, dubbed Hemocoat, is designed to bind with more albumin in the bloodstream, promoting tissue growth over the implant while tamping down platelet activation. 

In preclinical animal models, the coating showed fewer blood clots and reduced inflammation, according to the company. The new implant is also being studied in pre- and postmarket human clinical trials.

“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 [left atrial appendage closure],” Kenneth Stein, M.D., Boston Scientific’s global chief medical officer, said in a statement. 

“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,” Stein added.