Abbott’s TMVR system provides a minimally invasive replacement option for the leaky or narrowed valve. Credit: Sundry Photography / Shutterstock.

The US Food and Drug Administration (FDA) has granted approval for Abbott’s Tendyne transcatheter mitral valve replacement (TMVR) system for individuals with mitral valve disease.

This device claims to be the first of its kind to replace the mitral valve without the need for open-heart surgery.

It is now available for those whose mitral valves are not working properly due to severe mitral annular calcification (MAC), a condition characterised by calcium buildup within the annulus supporting this valve.

Abbott noted that for severe MAC patients at elevated risk for open-heart surgery, as well as those whose mitral valves could not be repaired with the company’s MitraClip device, the TMVR system provides a minimally invasive replacement option for the leaky or narrowed valve.

Tendyne is indicated for treating symptomatic severe mitral valve dysfunction in patients unsuitable for traditional surgical or transcatheter edge-to-edge repair.

Designed to accommodate various patient anatomies, Tendyne is available in several sizes and features a self-expanding valve that can be delivered via a small chest incision and progressed into the heart for mitral valve replacement.

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The valve is retrievable and repositionable during implantation, optimising patient outcomes.

According to Abbott, the health circumstances and requirements of patients, along with the intricate nature of mitral valve disease, present a challenge for surgical intervention.

Abbott’s structural heart business senior vice-president Sandra Lesenfants said: “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.

“This approval builds on our more than two decades of mitral valve leadership, which includes developing first-of-their-kind devices that truly change – and save – people’s lives.”

Abbott’s recent REFLECT studies on its FreeStyle Libre continuous glucose monitoring (CGM) technology have cut the risk of hospitalisation for heart complications in individuals with diabetes.

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