Tendyne has announced that its bioprosthetic mitral valve was successfully implanted in the first patient in the USA as part of a multicentre global feasibility study that aims to provide early insights into the safety and performance of the device in patients with symptomatic mitral regurgitation of degenerative or functional aetiology.
Wesley Pederson (an interventional cardiologist and principal investigator; Minneapolis Heart Institute, Minneapolis, USA) and R Saeid Farivar (a cardiothoracic surgeon and co-principal investigator), performed the implantation together with Paul Sorajja, Benjamin Sun, and Richard Bae. 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.”
A press release reports that 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.