US Feasibility Trial of Tendyne's TMVR System Begins Enrollment

April 13, 2015—Tendyne Holdings, Inc. announced the beginning of enrollment in the United States trial evaluating the Tendyne bioprosthetic transcatheter mitral valve system. The trial is part of a multicenter global feasibility study that aims to provide early insights into the safety and performance of the Tendyne system in patients with symptomatic mitral regurgitation of degenerative or functional etiology.

A team led by principal investigator Wesley Pederson, MD, an interventional cardiologist, and coprincipal investigator R. Saeid Farivar, MD, a cardiothoracic surgeon, performed the first procedure in the trial at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minnesota.

According to the company, the Tendyne device is fully repositionable and retrievable to provide total control during the procedure. The valve is comprised of a trileaflet porcine pericardial valve sewn onto a nitinol frame that is tethered to the apex of the heart. 

In the company’s press release, Dr. Pederson commented, “We are proud to be the first center in the United States to implant the Tendyne bioprosthetic mitral valve. The implant was simple and straightforward and the patient is doing well. This milestone marks the beginning of a new era of transcatheter valve replacement for patients with malfunctioning mitral valves.”

Dr. Farivar added, “The Tendyne bioprosthetic mitral valve was implanted in a beating heart, without open heart surgery, without cardiopulmonary bypass, and the device performed as intended with a remarkable absence of postprocedural mitral regurgitation. We believe this device has the potential to offer a safe and effective solution for patients that are not suitable candidates for traditional open heart mitral valve surgery.”