Abbott’s MitraClip implant just got a new sibling. The FDA has approved the company’s Tendyne system, as a minimally invasive heart replacement for patients with mitral valve disease that would otherwise make them ineligible for the top-selling device.
That includes patients whose mitral valves have severe annular calcification, or a buildup of hardened deposits around the valve’s ring-like base, causing backward-flowing leaks in the valve or a narrowing that hampers blood flow.
This condition can also complicate open surgery, and many affected patients also have co-morbidities that may bar them from undergoing a major procedure.
“Tendyne is a much-needed addition to our comprehensive U.S. structural heart portfolio that offers less invasive treatment options for a range of heart diseases,” Sandra Lesenfants, senior VP of Abbott’s structural heart business, said in a statement.
While the MitraClip transcatheter repair device works by holding together the valve’s leaflets, drawing them tight to form a better seal, Tendyne’s self-expanding valve replacement includes a dual-frame design—an inner bioprosthetic, plus an outer ring that contours to the shape of the patient’s natural mitral valve—and is available in multiple sizes.
The implant is also attached to a permanent tether linked to an anchoring pad, which also helps seal the small hole made in the heart wall to access its inner chambers. The company said this tether also allows clinicians to confidently control its placement, including the ability to retrieve and reorient the implant during the procedure.
The Tendyne system previously received a European approval in January 2020. Abbott acquired the valve through the $225 million acquisition of its eponymously named Minnesota developer in 2015.
More recently, Edwards Lifesciences picked up a CE Mark on the continent for its own transcatheter mitral valve replacement—one that it describes as the first that can be routed through the femoral vein in the leg, instead of implanted through an incision in the chest.
Boston Scientific is starting to lay a path in this space as well, backing 4C Medical in a $175 million funding round as the startup works to complete the pivotal development of its globe-shaped AltaValve.