JC Medical TAVR System Implanted for First Time Outside China

February 25, 2016—JC Medical, Inc. announced the successful implantation of its J-Valve bioprosthesis using the Ausper transapical delivery device in a patient in Canada. The J-Valve Ausper system is a next-generation transcatheter aortic valve replacement (TAVR) system, which is designed to treat aortic regurgitation, as well as aortic stenosis.

The company noted that the procedure is the first implantation of the J-Valve Ausper system outside of China, where the device has been used in more than 100 patients. JC Medical is currently pursuing market approval of the J-Valve Ausper TAVR system in China.

According to the company, the procedure was performed by Jian Ye, MD, Clinical Professor of Surgery and Director of Cardiac Surgery Research, and John Webb, MD, Director of Interventional Cardiology, at St. Paul’s Hospital in Vancouver, British Columbia. The patient had debilitating heart failure symptoms caused by severe aortic regurgitation and was considered to be at a high risk for open heart aortic valve replacement surgery.

In JC Medical’s press release, Dr. Ye commented, "The J-Valve is a unique valve designed for both aortic regurgitation (noncalcified valves) and aortic stenosis (severe calcification). Most TAVR devices are designed for aortic stenosis. Up to date, there are no transcatheter valves approved for the treatment of pure aortic regurgitation in North America. The J-Valve is relatively easier to implant compared with other valves and provides true anatomical positioning. Furthermore, no rapid ventricular pacing is required during the entire procedure, which reduces myocardial stress. The clinical trial in China has showed good early outcomes.”