First-in-Human Procedures Conducted for Valcare Medical's Amend Annuloplasty Ring

June 20, 2016—Valcare Medical announced the successful completion of the initial phase of its first-in-human (FIH) multicenter clinical trial for the company’s Amend mitral valve repair annuloplasty ring. The trial is being conducted in Israel and Europe. Valcare is an Accelmed portfolio company, which is an Israel-based investment firm.

According to the company, the Amend device is a semirigid, D-shaped ring that emulates the current gold standard for patients with mitral valve regurgitation. In a series of cases, the ring was successfully delivered via transapical access through an advanced, catheter-based delivery system and was secured to the annulus by a series of novel integral anchors.

Prof. Amit Segev, MD, and Prof. Ehud Ra'anani, MD, performed one of the procedures in the study. Prof. Segev is Director, Cardiac Catheterization Services at The Heart Center and Prof. Ra’anani is Head of the Cardiothoracic Surgery Department at Sheba Medical Center in Ramat Gan, Israel.

In the company’s announcement, Professors Segev and Ra’anani stated, “The procedure was performed on a high surgical risk patient, in a minimally invasive transapical approach and in a relatively short time. Using the Valcare system, we were able to repair the patient's mitral valve and significantly reduce valvular incompetence, reducing [mitral regurgitation] from severe (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.”

Additionally, the Amend system was implanted successfully at Shaare Zedek Medical Center in Jerusalem, Israel, and in a compassionate care procedure at the Padova University Hospital in Padova, Italy.