Minimally Invasive Implant Replaces the Mitral Valve

A novel device provides a safe and effective solution for mitral regurgitation (MR) patients who are not candidates for open-heart surgery or transcatheter mitral valve repair.

The Abbott (Abbott Park, IL, USA) Tendyne transcatheter mitral valve Implantation (TMVI) system is based on a self-expanding tri-leaflet, bioprosthetic valve that replaces the native mitral valve without open-heart surgery. The device is stabilized by a pad and tether mechanism that holds it in place inside the native valve. Delivery is via a small left anterior thoracotomy under continuous real-time 3D transesophageal echocardiographic (TEE) guidance. The Tendyne device is repositionable and fully retrievable, and conforms to a broad range of anatomies, allowing for better outcomes and procedural ease-of-use.

The Tendyne TVMI joins Abbott’s MitraClip, a 4 mm-wide cobalt-chromium clip (coated in polyester to promote tissue growth) that clamps to the mitral valve's two edges, holding them together. Among the benefits of the MitraClip are a positive safety profile, reduction in mitral regurgitation, favorable left ventricular remodeling, improvement in patient symptoms, and reduction in hospitalizations for heart failure (HF). Since the heart beats normally during the placement procedure, a heart-lung bypass machine is not required.

“The launch of the Tendyne device builds upon our history of developing groundbreaking therapies that offer new treatment options for people with serious structural heart conditions who have limited treatment options,” said Michael Dale, senior vice president of Abbott's structural heart business. “The availability of Tendyne as a treatment option in Europe provides physicians with an additional tool that has been shown to completely correct MR in very ill patients, and it adds to Abbott's portfolio of life-changing and life-saving treatments.”

“Abbott's Tendyne mitral valve replacement therapy provides the clinical community with a new choice in how we approach correcting a leaking mitral valve,” said professor of cardiac surgery Hendrik Treede, MD, of University Hospital Bonn (Germany). “For the first time outside of clinical trial settings, heart teams now have a minimally invasive valve replacement therapy that is backed by an excellent safety profile and designed to help physicians reposition the device as needed for improved patient outcomes.”

MR is a condition in which the heart's mitral valve leaflets do not close tightly, allowing blood to flow backward from the heart's left ventricle into the left atrium. There are two types of MR: degenerative and functional. Degenerative MR is caused by damage to the mitral valve leaflets; functional MR is caused by enlargement of the heart. MR is the most common type of heart valve insufficiency in the United States.

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