First Patient in Tendyne’s U.S. Transcatheter Mitral Valve Replacement Trial

Clinical stage medical device company, Tendyne Holdings, Inc., tells us its Tendyne Bioprosthetic Mitral Valve was successfully implanted in a first patient in the United States.

Background

Left untreated, mitral regurgitation can lead to heart failure and death. Yet for some sick patients the option of conventional surgical approach is not available. Hence the momentum behind efforts to follow the successful introduction of transcatheter aortic va;ve replacements, with a mitral option as we’ve covered recently on our pages.

Tendyne says its eponymous Bioprosthetic Mitral Valve System is designed to give physicians total control during the procedure with a device that is fully repositionable and retrievable. The valve itself is comprised of a tri-leaflet porcine pericardial valve sewn onto a Nitinol frame that is tethered to the apex of the heart.

 

The freshly-announced implantation was part of a multi-center global feasibility study that aims to provide early insights into the safety and performance of the system in patients with symptomatic mitral regurgitation of degenerative or functional etiology.

The implantation was performed by Interventional Cardiologist and Principal Investigator, Dr. Wesley Pederson, and Dr. R. Saeid Farivar, a Cardiothoracic Surgeon and Co-Principal Investigator, of the Minneapolis Heart Institute® and Abbott Northwestern Hospital.

Investigator comments

Dr. Pederson said, “We are proud to be the first center in the US 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 post procedural 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.”

Company comments

Tendyne CEO Jeff Franco said, “Enrolling the first patient in the US into our global feasibility trial is an important milestone for Tendyne and the physician community. We are dedicated to helping physicians deliver excellent care to their patients and we are excited to partner with Minneapolis Heart Institute Foundation and Abbott Northwestern Hospital.”

Source: PR Newswire

 

 

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