Abbott announces pivotal trial for its mitral valve replacement system

Abbott announced it will conduct a clinical study in the U.S. of its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of mitral regurgitation (MR).

Dubbed SUMMIT, the trial will enroll up to 1,010 patients at 80 study sites across the U.S., the European Union (EU) and Canada, to test the device’s safety and efficacy, which allows physicians to replace damaged mitral heart valves without open heart surgery.

The device, Abbott said, is the first and only repositionable and fully retrievable mitral valve replacement. Results from the global study, which tested the device on 100 patients, showed patients treated with Tendyne had a significant reduction in symptoms of MR and low mortality rates at 30 days.

"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 Bassem M. Chehab, MD, medical director of Via Christi's structural heart program, who implanted the first patient in the study with the Tendyne valve in a prepared statement. "I'm encouraged by promising early results from the global study and excited about the potential for the Tendyne device to advance the field of transcatheter mitral valve replacement in the U.S. by providing another option for MR patients needing a minimally invasive alternative."

Abbott first entered into the minimally invasive mitral valve repair market with MitraClip, which has been on the market since 2008 in the EU and 2013 in the U.S. More than 65,000 patients have been treated with the minimally invasive therapy that is delivered to the heart through a blood vessel in the leg.