LOTUS Edge, a Repositionable Transcatheter Aortic Valve, Approved in U.S.

Boston Scientific won FDA approval for its LOTUS Edge Aortic Valve System for transcatheter valve replacements. It’s indicated for people with severe aortic stenosis who are poor candidates for open heart surgery, but as is the case these days with other transcatheter heart valves, it’s bound to be heavily used off-label.

Unlike other transcathether aortic valves, the LOTUS Edge can be repositioned, and removed if necessary, after it has been expanded within the native valve. The metallic frame of the valve is actually braided nitinol, and a novel seal that adapts to the anatomy of the patient helps to prevent leaking and paravalvular regurgitation. The actual leaflets of the valve are made out of decellularized bovine pericardium.

Here’s a Boston Scientific video presenting the LOTUS Edge:

Product page: LOTUS Edge Aortic Valve System…

Via: Boston Scientific…