Abbott Begins U.S. Pivotal Trial for the Tendyne Mitral Valve Replacement System to Treat Patients with Heart Valve Disease
ABBOTT PARK, Ill.,
The study, called SUMMIT, will enroll up to 1,010 patients at 80 sites in the U.S., EU and
Mitral regurgitation is a debilitating, progressive and life-threatening disease in which the heart's mitral valve does not close completely, causing blood to flow backward and leak into the left atrium of the heart. The condition can raise the risk of irregular heartbeats and stroke, and if left untreated, could ultimately lead to heart failure and death. Nearly one in 10 people over the age of 75 have moderate to severe MR1, which is often difficult to diagnose. Abbott's MitraClip is the leading approved device to repair a leaking mitral valve, but there are currently no approved minimally invasive therapies to replace the mitral valve.
The Tendyne valve may provide a life-saving treatment option for MR patients by replacing their native mitral valve without open-heart surgery to reduce their heart failure symptoms. The device is a tri-leaflet, bioprosthetic valve available in multiple sizes, and is stabilized by a pad and a tether mechanism that holds the pad in place where it's been implanted inside the native valve. As the first and only repositionable and fully retrievable replacement valve, Tendyne can conform to a broad range of anatomies, which may allow for better outcomes and procedural ease-of-use.
"The mitral valve is known for its complex anatomy and, as a result, managing mitral regurgitation can be challenging, especially in elderly or frail patients for whom there are limited to no treatment options," said
Abbott recently shared data at EuroPCR, the annual meeting of the
"Transcatheter mitral valve replacement represents a new frontier in treating people whose valve does not close properly and who would benefit from a replacement valve instead of repair," said
In addition to the U.S. pivotal trial, Abbott will initiate a separate feasibility study of the Tendyne system in patients with severe mitral annular calcification (MAC), a condition in which calcium accumulates along and beneath the mitral valve annulus, a ring-like structure that separates the top and bottom chambers of the left side of the heart.
Abbott is a global leader in the treatment of mitral regurgitation with the MitraClip device, which has been on the market in the EU since 2008 and in the U.S. since 2013 to repair the mitral valve. More than 65,000 patients have been treated with this first-of-its-kind minimally invasive therapy, that is delivered to the heart through a blood vessel in the leg. Abbott has continued to innovate the treatment of mitral regurgitation to ensure patients have minimally invasive options to open-heart surgery.
For U.S. Important Safety Information on MitraClip, visit http://mitraclippossibilities.com/#isi-sec.
The Tendyne Transcatheter Mitral Valve Replacement system is an investigational device only.
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1 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG,
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SOURCE Abbott
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