FDA approves LOTUS Edge Aortic Valve System to treat severe aortic stenosis

Boston Scientific Corporation announced it has received FDA approval for the LOTUS Edge Aortic Valve System. Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.

The LOTUS Edge valve system is the only FDA-approved aortic valve that 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 (PVL) by conforming to the patient’s native aortic valve.

The FDA approval of the LOTUS Edge valve system adds to the Boston Scientific suite of Structural Heart product solutions – including the SENTINEL Cerebral Protection System and the WATCHMAN Left Atrial Appendage Closure Device – available in the U.S., as well as the ACURATE neo Aortic Valve System* in Europe. The company commenced a controlled launch of the valve system in Europe in March and expects to begin a controlled launch in the U.S. in the coming weeks.