Boston Scientific Receives FDA Approval for Lotus Edge TAVR System
April 23, 2019—Boston Scientific Corporation announced that it has received FDA approval for its Lotus Edge aortic valve system for transcatheter aortic valve replacement (TAVR). The device is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement.
According to the company, the Lotus Edge system gives physicians the option to reposition and completely recapture the valve once it has been fully deployed. It also features a braided valve frame and an adaptive seal that minimizes paravalvular regurgitation or leaking by conforming to the patient’s native aortic valve.
In March, the company commenced a controlled launch of the Lotus Edge valve system in Europe. A controlled launch in the United States is expected to begin in the coming weeks, advised Boston Scientific.