Abbott’s Tendyne Device Receives FDA Approval for Minimally Invasive Mitral Valve Replacement

The newly approved system targets mitral regurgitation or stenosis in patients with severe MAC, offering a viable solution where few options previously existed.

Abbott has recently received the US Food and Drug Administration (FDA) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system.

The device is specifically approved for patients with severe mitral annular calcification (MAC), which involves calcium buildup in the mitral valve's supporting ring. This makes traditional surgical intervention extremely risky or unviable.

Tendyne provides a minimally invasive alternative for patients who are not candidates for open-heart surgery or mitral valve repair using Abbott's MitraClip device.

Further, the newly approved system targets mitral regurgitation or stenosis in patients with severe MAC, offering a viable solution where few options previously existed.

This FDA approval expands Abbott’s portfolio of less invasive cardiovascular therapies in the US.

According to the company, Mitral annular calcification stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupt the heart's ability to pump blood effectively. These conditions can have a significant impact on a patient's quality of life, causing symptoms such as chest pains, shortness of breath and dizziness.

The Tendyne system is designed to adapt to various patient anatomies due to its availability in multiple sizes and self-expanding valve technology.

Delivered through a small incision in the chest, the valve can be repositioned or retrieved during implantation, increasing the likelihood of successful outcomes and enhancing patient safety.

"Tendyne is a much-needed addition to our comprehensive US 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.

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