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Abbott's investigational Tendyne device for mitral valve replacement demonstrates positive outcomes at 30 days in global study

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PARIS, May 23, 2018 /PRNewswire/ -- Abbott (NYSE: ABT) today announced favorable outcomes from the first 100 patients treated in a global study of its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system, the first and only mitral replacement valve that is repositionable and fully retrievable to allow for more precise implantation, helping improve patient outcomes. The trial is the largest study of a transcatheter mitral valve replacement device to date. Results at 30 days demonstrated that Tendyne is associated with a significant reduction of mitral regurgitation symptoms and low mortality rates. The data were presented during a late-breaking session at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in Paris.

Mitral regurgitation (MR) 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, stroke and heart failure. Nearly one in 10 people over the age of 75 have moderate to severe MR1, which is often difficult to diagnose.

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Tendyne is a first-of-its-kind device that offers patients with severe MR a life-saving treatment option, replacing their native mitral valve without open heart surgery to reduce their heart failure symptoms. As the first and only repositionable, fully retrievable and minimally invasive replacement option, Tendyne's unique features help physicians correctly implant the device for improved patient outcomes.

"Treating people with severe mitral regurgitation can be challenging because of advanced age, frailty or other complicating factors, and alternative treatments to surgery are needed," said principal investigator David Muller, MBBS, M.D., St Vincent's Hospital, Sydney, Australia. "These new data on the Tendyne replacement valve offer early hope for patients who are not eligible for transcatheter valve repair or surgery to relieve symptoms."

The global study plans to enroll up to 350 adult patients with symptomatic MR who are not eligible for open-heart surgery to repair or replace the mitral valve. The primary endpoints of the study are safety – defined as device success and freedom from device- and procedure-related serious adverse events – and performance assessed by reduction in mitral regurgitation severity. Left untreated, MR may result in a variety of symptoms, heart failure, and ultimately death.
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