Tendyne Announces First Patient Enrolled in US Trans-Catheter Mitral Valve Replacement Trial
ROSEVILLE, Minn., April 13, 2015 -- Tendyne Holdings, Inc. ("Tendyne") a privately held clinical stage medical device company, announced today the Tendyne Bioprosthetic Mitral Valve was successfully implanted in the first patient in the United Statesas part of a multi-center global feasibility study that aims to provide early insights into the safety and performance of the Tendyne Bioprosthetic Mitral Valve System in patients with symptomatic mitral regurgitation of degenerative or functional etiology.
Dr. Wesley Pederson, an Interventional Cardiologist and Principal Investigator, and Dr. R. Saeid Farivar, a Cardiothoracic Surgeon and Co-Principal Investigator, performed the implantation together with Drs. Paul Sorajja, Benjamin Sun, Richard Bae, and Nurse Sara Olson, also of the Minneapolis Heart Institute® and Abbott Northwestern Hospital.
Commenting on the procedure 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."
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."
The Tendyne 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 is comprised of a tri-leaflet porcine pericardial valve sewn onto a Nitinol frame that is tethered to the apex of the heart. Left untreated, mitral regurgitation can lead to heart failure and death.
Tendyne Holdings, Inc., Roseville, Minnesota, USA, is a private clinical stage medical device company developing the Tendyne Bioprosthetic Mitral Valve System for Transcatheter Mitral Valve Replacement (TMVR). The Tendyne Bioprosthetic Mitral Valve System is an investigational device, not available for sale. All rights reserved. CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.