Medical equipment manufacturer Boston Scientific has received approval from the US Food and Drug Administration (FDA) for its Watchman Left Atrial Appendage Closure (LAAC) Device.
The new stroke risk reduction device has been developed as an alternative to long-term warfarin therapy for high-risk patients with non-valvular atrial fibrillation (AF).
The company has designed the catheter-delivered heart implant to close the left atrial appendage (LAA) in a bid to avoid the migration of blood clots from the LAA, thereby allowing to decrease the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.
Boston Scientific rhythm management president and executive vice president Joe Fitzgerald said: "Today marks a defining moment in the company’s journey towards establishing left atrial appendage closure therapy in the US.
"Boston Scientific is proud to offer this potentially life-changing stroke risk treatment option to high-risk patients with AF who have a reason to seek a non-drug alternative to warfarin."
Watchman LAAC Device will be used to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular AF based on CHADS2 or CHA2DS2-VASc scores, seeking a non-pharmacologic alternative to warfarin.
The approval was based on the Watchman clinical trial that comprised multiple studies with about 2,400 patients and nearly 6,000 patient-years of follow-up.
According to the company, the clinical program demonstrated that the device can be implanted safely and reduce the risk of stroke in eligible patients while enabling most patients to discontinue warfarin.
Watchman LAAC Device will be provided to US centers that are involved in firm’s clinical trials, in addition to specialized centers, where physicians are trained on the implant procedure.
Image: Watchman Left Atrial Appendage Closure Device. Photo: courtesy of Boston Scientific Corporation.