SUZHOU, China, April 24, 2021 /PRNewswire/ — A new interventional solution from China for structural heart disease is about to be launched onto the market. Recently, TaurusOne® Transcatheter Aortic Valve Replacement System (hereinafter referred to as “TaurusOne®”) developed by Peijia Medical (Suzhou) Co., Ltd., located in Suzhou Industrial Park, Jiangsu Province, was officially approved for commercialization by the National Medical Products Administration of the PRC (“NMPA”) with registration number GXZZ 20213130275.
Academician Gao Runlin of Fuwai Hospital Chinese Academy of Medical Sciences served as Principal Investigator for the TaurusOne® registration clinical trial completed by National Centre for Cardiovascular Disease, Fuwai Hospital, The Second Affiliated Hospital ZheJiang University School of Medicine, West China Hospital of Sichuan University, General Hospital of Northern Theater Command, the Second Affiliated Hospital of Harbin Medical University and the Second Xiangya Hospital of Central South University (in order of institution codes listed in the multi-center clinical trial protocol). The clinical trial protocol employed strict enrollment criteria and passed the pre-clinical review and got approved by the CFDA (now NMPA). One-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 NMPA registration approval of TaurusOne® is an important milestone for Peijia,” said Dr. Zhang Yi, Chairman and CEO of Peijia Medical, “From now on, doctors in China will have a new product to conduct TAVR procedures, while patients suffering from aortic stenosis will have an additional solution.”
TaurusOne® consists 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 a proprietary anti-calcification technique. The stent’s inflow end has an enhanced radial force design, given that China has a large proportion of patients with high aortic valve calcification or bicuspid aortic valves. A balanced waist design avoids blockage of the coronary artery while also maintaining a large orifice area. The inflow end is designed with inner and outer skirts to effectively avoid or reduce paravalvular leakage. The delivery catheter is