Boulle Medtech has announced that the Tendyne transcatheter mitral valve implant was successfully placed in the first patient enrolled in a three-continent, multicentre trial being conducted as part of the Tendyne feasibility study. The study is to generate insight into the safety and performance of the Tendyne device in inoperable patients suffering from mitral regurgitation.
David Muller and Paul Jansz performed the procedure at St Vincent’s Hospital in Sydney, Australia. Tendyne reports that the device was implanted transapically without cardiopulmonary bypass, performed as intended by completely eliminating mitral regurgitation, and that the patient was released from the hospital on day five. Prior to this, the Tendyne device had been successfully implanted in London in three other persons under a compassionate use protocol in October and early November 2014.
The Tendyne transcatheter mitral valve implant is a fully retrievable and repositionable, apically tethered tri-leaflet porcine pericardial valve sewn onto a Nitinol (nickel/titanium) frame specifically designed to address the mitral anatomy of functional, degenerative and mixed aetiology mitral regurgitation.