Next-generation LAA closure device for patients with nonvalvular AF gains FDA approval
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Key takeaways:
- A next-generation LAA closure device gained FDA approval to reduce risk for stroke in patients non-valvular AF.
- The device is indicated for patients needing an alternative to oral anticoagulation.
Boston Scientific announced it received FDA approval for its next-generation left atrial appendage closure device indicated to reduce risk for stroke in certain patients with nonvalvular atrial fibrillation.
The device (Watchman FLX Pro), indicated for patients needing an alternative to oral anticoagulation, features a polymer coating designed to reduce device-related thrombus risk and expedite healing and endothelization and visualization markers to guide device placement and improve the LAA seal, according to a company press release.
In addition, the device is also available in a 40-mm size option, which will enable treatment of a wider range of patients, according to the release.
As Healio previously reported, the company’s second-generation LAA closure device (Watchman FLX) was approved in July 2020 for the reduction of stroke risk in patients with nonvalvular AF who required LAA closure as an alternative to oral anticoagulation.
Preclinical studies indicated that the polymer coating was associated with an 86% reduction in inflammation 3 days after LAA closure; a 70% reduction of thrombus at 14 days; and a 50% increase in endothelial tissue coverage at 45 days, according to the 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 LAA [closure]," Kenneth Stein, MD, senior vice president and global chief medical officer at Boston Scientific, said in the release. "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 next-generation device is currently being studied in the WATCHMAN FLX Pro CT study and will be further evaluated in the postmarket HEAL-LAA study, which will commence over the coming weeks, according to the release.
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