Chinese device firm JC Medical said today that the 1st implantation of its J-Valve bioprosthesis transcatheter aortic valve implant was performed outside China in Vancouver, Canada.
The patient in the operation suffered from heart failure due to severe aortic regurgitation and was considered high risk for open-heart aortic valve replacement surgery due to the condition.
“The J-Valve is a unique valve designed for both aortic regurgitation and aortic stenosis. 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,” performing surgeon Dr. Jian Ye of Vancouver’s St. Paul’s Hospital said in a press release.
JC Medical said it is pursuing market approval of the J-Valve Ausper TAVI system in China. Currently, Tavi devices are only indicated for use in patients with aortic stenosis, and the company’s J-Valve Ausper 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. We thank the physician group who has recognized this unique clinical solution,” ,” said Ji Zhang, M.D., founder and CEO of JC Medical.