Early data from Abbott’s Tendyne TMVR trial indicates reduced MR, low mortality rates
Abbott (NYSE:ABT) today released outcome data from the first patients treated in a study of its Tendyne transcatheter mitral valve replacement system, claiming significant reductions in mitral regurgitation symptoms and low mortality rates.
The company touted the ongoing study as the largest of a transcatheter mitral valve replacement device to date, and said that the Tendyne TMVR system is the first and only mitral valve replacement that is repositionable and fully retrievable.
“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. 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,” principal investigator Dr. David Muller of Sydney, Australia’s St Vincent’s Hospital said in a prepared statement.
The trial is slated to enroll 350 adult patients with symptomatic mitral regurgitation who are not eligible for open-heart surgery to repair or replace the mitral valve. The study will include primary endpoints of safety as defined by device success and freedom from device and procedure-related serious adverse events, and of performance as indicated by reduced mitral regurgitation severity.
Early results from the trial come from 97 of the first 100 patients, and indicated significant reductions in mitral regurgitation at 30 days and improvements based on the New York heart Association grade severity and the Kansas City Cardiomyopathy Questionnaire.
At baseline, 99% of patients already enrolled had an MR grade of greater than or equal to 3+, which was reduced to none or trace amounts in 98.7% of patients at 30 days. Data also indicated a 97% implant success rate with no associated deaths or strokes. The rate of serious adverse events and mortality was 6%, better than the 7.9% STS-predicted mortality for surgical valve replacements.
“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. 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,” Abbott structural heart biz VP Michael Dale said in a press release.
The Tendyne valve is currently under clinical investigation in Europe, though Abbott is hopeful it will begin enrollment in its US Pivotal trial in the coming months.