US-based medical device firm Tendyne Holdings has started patient enrolment in its multi-centre global feasibility trial of its Tendyne Bioprosthetic Mitral Valve (TMVR) system in patients with symptomatic mitral regurgitation of degenerative or functional etiology.
As part of the trial, the Tendyne Bioprosthetic Mitral Valve was successfully implanted in the first patient in the US.
The trial is designed to provide early insights into the safety and performance of the Tendyne Bioprosthetic Mitral Valve system in these patients.
The implantation was conducted by principal investigator Dr Wesley Pederson and co-principal investigator Dr Saeid Farivar.
Dr Pederson said: "We are proud to be the first centre 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."
The TMVR system is designed to offer physicians total control during the procedure with a device that is fully repositionable and retrievable.
The device comprises of a trileaflet porcine pericardial valve sewn onto a nitinol frame that is tethered to the apex of the heart.
Dr Farivar said: "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."