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 New York Heart Association (NYHA) grade severity and the Kansas City Cardiomyopathy Questionnaire (KCCQ), important assessment methods of patients' health status. The KCCQ score is the standard tool used to assess quality of life in patients with MR, and improvements were observed in treated patients.

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 Society of Thoracic Surgeons score used to predict long-term survival. This represented a favorable 0.76 (6/7.9) ratio of observed-to-expected mortality, or a measure of assumed patient deaths due to age or other comorbities beyond a care team's control.


Tendyne is currently under clinical investigation in Europe, and Abbott expects to enroll the first patient in the U.S. pivotal trial in the coming months. Abbott is a global leader in the treatment of MR with the MitraClip® device, which has been on the market in the EU since 2008 and in the U.S. since 2013. More than 60,000 patients have been treated with this first-of-its-kind therapy, a catheter-based, minimally invasive device that is delivered to the heart through a blood vessel in the leg.

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 Michael Dale, vice president of Abbott's structural heart business. "As leaders in transcatheter mitral valve repair, we look forward to advancing another minimally invasive treatment option with unique benefits for people with complex structural heart conditions in need of mitral valve replacement."

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