Abbott's Investigational Tendyne™ Device for Mitral Valve Replacement Demonstrates Positive Outcomes at 30 Days in Global Study
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.
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
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.
In these early results from the study, investigators successfully implanted the Tendyne system in 97 of the first 100 patients. Treated patients experienced a significant reduction in mitral regurgitation at 30 days, as well as improvements in symptoms based on
At baseline, 99.0 percent of patients enrolled had a MR grade of ≥ 3+, which at 30 days was reduced to none or trace in 98.7 percent of patients. Data showed a 97 percent implant success rate with no associated deaths or strokes. The 30 day results demonstrated low rates of serious adverse events and low mortality (6 percent (6/100) vs. 7.9 percent STS-predicted mortality for surgical valve replacement, or the
Tendyne is currently under clinical investigation in
By securing a portion of the leaflets of the mitral valve with a clip, the heart can pump blood more efficiently throughout the body, thereby relieving the symptoms of severe MR and improving patient quality of life.2 For MR patients who are not candidates for traditional open-heart surgery or a minimally invasive mitral valve repair, Tendyne may offer a new valve replacement treatment option.
"Tendyne was specifically designed to address the functional, degenerative and mixed causes of mitral regurgitation that cannot be addressed through minimally invasive valve repair or open-heart surgery," said
For U.S. important safety information on MitraClip, visit https://mitraclip.com/#isi.
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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