29.12.2014 – 13:20
Jean Boulle Group Reports Successful First Clinical Trial Implant of the Tendyne Transcatheter Mitral Valve
Boulle Medtech Ltd, a Jean Boulle Group company focusing on medical technology and a founding investor of Tendyne Holdings, Inc. ("Tendyne"), is pleased to announce that the Tendyne Transcatheter Mitral Valve Implant (TMVI) was successfully placed in the first patient enrolled in a three-continent, multicenter 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.
Drs. 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 5. 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 (see Boulle Medtech release of December 10, 2014).
The Tendyne TMVI 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 etiology mitral regurgitation. Left untreated, mitral regurgitation can lead to heart failure and death.
About Boulle Medtech Ltd.
Boulle Medtech Ltd. is a Jean Boulle Group company focusing on medical technology. Its holdings include Tendyne Holdings, Inc. Boulle Medtech is a founding investor and major shareholder of Tendyne.
About Tendyne Holdings, Inc.
Tendyne Holdings, Inc is headquartered in Roseville, Minnesota and is a privately-held, clinical stage medical device company developing a unique Transcatheter Mitral Valve Implant (TMVI). Implanted in a beating heart in a hybrid operating room, the Tendyne design has proprietary and patented features that can treat a variety of mitral pathologies. With a less invasive approach than open cardiac surgery, TMVI may result in similar outcomes with fewer surgical complications.
For more information about Tendyne, go to http://www.tendyne.com.