FDA approves Abbott mitral valve replacement device that doesn’t require open-heart surgery

 Abbott (NYSE: ABT)

 announced today that it received FDA approval for its Tendyne transcatheter mitral valve replacement (TMVR) system.

The TMVR system offers an option for patients with mitral valves that fail to function properly due to severe mitral annular calcification (MAC). MAC stiffens the annulus ring-like structure that supports the mitral valve. This can  lead to mitral regurgitation or stenosis, disrupting the heart’s ability to effectively pump blood.

Some patients with severe MAC at high risk for open-heart surgery can’t have their valve repaired with Abbott’s MitraClip, according to a news release. For this population, Tendyne delivers an alternative, minimally invasive way to replace the leaky (mitral regurgitation) or narrowed (stenosis) valve.

Dr. Paul Sorajja, director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital, says these conditions can have a significant impact on a patient’s quality of life. Such patients prove difficult to operate on, too, according to Sorajja.

“Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives,” Sorajja said.

Abbott said Tendyne’s unique, innovative design and availability in multiple sizes allows it to adapt to a range of patient anatomies. Delivered through a small incision in the chest, the self-expanding valve replaces the mitral valve. It remains fully repositionable and retrievable during implantation, too.

“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,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “This approval builds on our more than two decades of mitral valve leadership that includes developing first-of-their-kind devices that truly change – and save – people’s lives.”

https://www.massdevice.com/fda-approves-abbott-tendyne-tmvr-device/