Boulle Medtech Ltd., a Jean Boulle Group private company focusing on medical technology, and founding investor of Tendyne Holdings, Inc. (Tendyne), has announce that Tendyne's Transcatheter Mitral Valve device has been successfully implanted in three patients.
The procedures are the first in a series to be performed at various hospitals worldwide. Tendyne reports that the patients had severe mitral regurgitation that was eliminated after the procedure was performed via a trans-apical approach without cardio-pulmonary bypass (known as a trans-catheter mitral valve implantation, or "TMVI").
These first three procedures were conducted at the Royal Brompton Hospital in London, England by Dr. Neil Moat, a leading expert in mitral valve and trans-catheter mitral valve implantation. Tendyne further reports that all three patients had no major in-hospital complications and have been discharged from hospital.
The Tendyne TMVI is a fully-retrievable and repositionable, apically tethered tri-leaflet porcine pericardial valve sewn onto a nickel-titanium frame specifically designed to address the complex mitral anatomy of functional, degenerative and mixed etiology mitral regurgitation. Left untreated, mitral regurgitation can lead to heart failure and death. Implanted in a beating heart in a hybrid operating room, the Tendyne valve has proprietary and patented features that permit a significantly less invasive procedure to mitral valve treatment than open heart surgery.