BURLINGAME, Calif.--JC Medical, Inc. announced today that it has successfully completed an implantation of its J-Valve bioprosthesis using the Ausper transapical delivery device in Vancouver, Canada. The J-Valve Ausper system represents the next generation transcatheter aortic valve implantation (TAVI) system and has been previously used in more than 100 patients in China. This operation is the first implantation of the J-Valve Ausper system outside of China.
The implantation was performed by Jian Ye, M.D., clinical professor of surgery and director of cardiac surgery research, and John Webb, M.D., director of interventional cardiology at St. Paul's Hospital in Vancouver.
The patient suffered from debilitating heart failure symptoms due to severe aortic regurgitation and was considered to be at a high risk for open-heart aortic valve replacement surgery due to his condition.
"The J-Valve is a unique valve designed for both aortic regurgitation (non-calcified valves) and aortic stenosis (severe calcification)," Ye said. “Most TAVI 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.”
Aortic regurgitation, also known as aortic insufficiency, and aortic stenosis are both potentially life-threatening conditions related to the aortic valve that directs blood out of the heart to the rest of the body. An estimated 12 million people worldwide have heart valve diseases. Currently approved minimally invasive TAVI devices are only indicated for use in patients with aortic stenosis. The J-Valve Ausper TAVI System is designed to treat aortic regurgitation, as well as aortic stenosis.
“We are very pleased that our J-Valve system could help the patient in Canada,” said Ji Zhang, M.D., founder and CEO of JC Medical. “We thank the physician group who has recognized this unique clinical solution.”
JC Medical is currently pursuing market approval of the J-Valve Ausper TAVI System in China.
About JC Medical, Inc.
JC Medical, Inc. is a privately held, venture-backed developer and manufacturer of TAVI systems. The company’s first product is a next generation TAVI system that addresses an unmet need in patients with aortic regurgitation as well as aortic stenosis. The company has operational sites in Burlingame, Calif., and Suzhou, China.