US-based medical device maker Abbott has secured the US Food and Drug Administration (FDA) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system.
Tendyne is a minimally invasive device that addresses mitral valve malfunction due to severe mitral annular calcification (MAC), a condition where calcium builds up in the annulus.
Annulus is a ring-like structure that plays a key role in the function of the heart valves.
The TMVR system provides a vital treatment option for patients with mitral valve disease, those with severe MAC who are ineligible for open-heart surgery or mitral repair.
Abbott said the FDA approval expands its portfolio of minimally invasive structural heart therapies in the US, providing an alternative to traditional surgical procedures.
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 that includes developing first-of-their-kind devices that truly change – and save – people’s lives.”
Tendyne is indicated for patients suffering from symptomatic severe mitral valve dysfunction, including moderate-to-severe or severe mitral regurgitation (MR), severe mitral stenosis (MS), or moderate MR with moderate or greater MS, associated with severe MAC.
The TMVR system is recommended for those deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.
It is contraindicated in patients with anticoagulation or antiplatelet intolerance, sepsis or active endocarditis, left ventricular or left atrial thrombus at risk of embolisation, a fragile apex unsuitable for a transapical procedure, or hypersensitivity to nickel or titanium.
In addition, patients not considered candidates by their local heart team due to clinical or anatomical factors should not undergo the Tendyne procedure.
The Tendyne system comes with an advanced design and is available in multiple sizes, enabling it to accommodate various patient anatomies.
The self-expanding valve is delivered via a small chest incision and advanced into the heart to replace the mitral valve.
Its repositionable and retrievable nature during implantation ensures optimal outcomes for patients requiring valve replacement.
Abbott Northwestern Hospital Minneapolis Heart Institute center for valve and structural heart disease director Paul Sorajja said: “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.
“Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives.”
