This article is more than 5 years old. Information may no longer be current.
Pivotal trial to evaluate repositionable, fully retrievable mitral valve replacement system
Click Here to Manage Email Alerts
A new pivotal trial is underway to examine efficacy and safety of a repositionable, fully retrievable transcatheter mitral valve replacement system for the treatment of mitral regurgitation.
The SUMMIT trial will enroll up to 1,010 patients at 80 sites in the United States, Europe and Canada to investigate the Tendyne transcatheter mitral valve replacement system. The primary composite endpoint is death, CV hospitalization, stroke or reoperation at 1 year. The trial will be led by co-principal investigators Jason Rogers, MD, professor and director of interventional cardiology at UC Davis Medical Center in Sacramento, and Gorav Ailawadi, MD, professor of surgery and chief of cardiac surgery at the University of Virginia. Several patients have been enrolled and treated thus far at Via Christi Hospital St. Francis in Wichita, Kansas, and the West Virginia University Heart and Vascular Institute in Morgantown, West Virginia, according to a press release from Abbott Vascular.
The Tendyne device is used to replace the native mitral valve. The device is a tri-leaflet, bioprosthetic valve that is available in multiple sizes. It is stabilized by a pad and a tether mechanism that holds the pad in place upon implantation inside the native valve. The device can confirm to a range of anatomies, according to the release.
Data from a global study of the Tendyne device were reported in May at the EuroPCR meeting in Paris. In 97 of the first 100 patients implanted with the Tendyne device, mitral regurgitation at 30 days was significantly reduced, health status improved and mortality was low, according to a press release.
“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,” Bassem M. Chehab, MD, medical director of Via Christi’s structural heart program, stated in the release. “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 [mitral regurgitation] patients needing a minimally invasive alternative.” Chehab implanted the first patient in the study with the Tendyne device.
In other news, Abbott announced that it also plans to initiate a feasibility study of the Tendyne system in patients with severe mitral annular calcification.
Disclosure: Chehab reports financial relationships with Abbott Vascular.