Valcare developed The Amend™ Mitral Valve Repair Annuloplasty ring, a semi-rigid, a ‘D’ shaped ring that emulates the current gold standard for patients who suffer from Mitral Valve Regurgitation (the valve that controls blood flow between the left atrium and left ventricle). In a series of cases, the ring was successfully Trans apically delivered through an advanced, catheter-based delivery system, and was secured to the annulus by a series of novel integral anchors.
Valcare Medical, an Accelmed portfolio company, the developer of novel medical devices for minimally invasive treatment of Mitral Valve Regurgitation, announced today the successful completion of first phase of the its First-In-Human (FIH) multi-center clinical trial, taking place in Israel and Europe.
System was implanted successfully by the heart team at Shaare Zedek Medical Center Interventional Cardiology laboratories in Jerusalem (Dr. Almagor & Dr. Mirkeen) and in a compassionate care procedure performed in April by Professor Gino Gerosa and Dr. Andrea Colli, Cardiac Surgeons from the Padova University Hospital in Italy.
“The procedure was performed on a high surgical risk patient, in a minimally-invasive transapical approach and in a relatively short time”, stated Prof. Amit Segev, Director, Cardiac Catheterization Services at The Heart Center at Sheba Medical Center, Israel and Prof. Ehud Ra’anani, Head of the Cardiothoracic Surgery Department who performed one of the procedures. “Using the Valcare system we were able to repair the patient’s mitral valve and significantly reduce valvular incompetence, reducing MR from sever (4+) to trace (1). We are excited to be one the first centers in the world to use this novel technology to help our patients.”
The Amend™ system is expected to address the $5 Billion market ($3 Billion in the US alone) for medical devices geared towards minimally invasive treatment of Mitral Valve disease. A recently granted US patent on the Valve in Ring enables Valcare to use the Amend™ device also for the replacement of the mitral valve and for tricuspid vale repair.
Report from globes.co.il