Peijia Medical’s TaurusOne TAVR System Approved in China

April 26, 2021—Peijia Medical (Suzhou) Co., Ltd. announced that the company’s TaurusOne transcatheter aortic valve replacement (TAVR) system has received regulatory approval from the National Medical Products Administration of the People’s Republic of China.

Gao Runlin, MD, of Fuwai Hospital Chinese Academy of Medical Sciences served as Principal Investigator for the multicenter TaurusOne registration clinical trial supporting approval of the device for commercialization in China.

According to the company, the 1-year clinical study data for TaurusOne definitively confirmed its safety and effectiveness as a treatment for severe aortic stenosis, with no significant difference in clinical results between the bicuspid aortic valve and tricuspid aortic valve.

The company noted that TaurusOne is composed of a prosthetic aortic valve, a delivery catheter, and a compression loading system. The aortic valve leaflet is made of bovine pericardium and is processed with the company’s anticalcification technique. The stent’s inflow end has an enhanced radial force design intended to address the large proportion of patients in China with high aortic valve calcification or bicuspid aortic valves. The delivery catheter has a maximum outer diameter of 18 F and is divided into several segments for easier, more flexible passage and delivery.

Approval of TaurusOne marks Peijia Medical’s entry into the TAVR market. TaurusElite, the company's second-generation TAVR device, is currently in the registration stage and the third-generation TaurusNxt device is in preclinical preparations, advised Peijia Medical.