Peijia Medical has received approval for commercialisation from China’s National Medical Products Administration (NMPA) for its TaurusOne Transcatheter Aortic Valve Replacement (TAVR) System.
The China-based medical technology company designed TaurusOne to comprise a prosthetic aortic valve, delivery catheter and a compression loading system.
The aortic valve leaflet is made out of bovine pericardium and is processed with a unique anti-calcification technique, said the company.
The inflow end of the stent features an enhanced radial force design, with inner and outer skirts to effectively avoid or reduce paravalvular leakage.
The balanced waist design will avoid blockage of the coronary artery while maintaining a large orifice area, and the ergonomic design of the delivery catheter will support accurate operations, said the company.
With a maximum outer diameter of 18 Fr, the delivery catheter is divided into several segments for easier, more flexible passage and delivery.
Peijia Medical chairman and CEO Zhang Yi said: “The NMPA registration approval of TaurusOne is an important milestone for Peijia.
“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.”
Peijia Medical has completed a registration clinical trial for TaurusOne, for which academician Gao Runlin served as principal investigator.
The clinical trial protocol employed stringent enrolment criteria and cleared the pre-clinical review and got approved by the CFDA (currently NMPA).
One-year data from the clinical trial confirmed the safety and effectiveness of TaurusOne in treating severe aortic stenosis, with no difference in results for bicuspid and tricuspid aortic valves.
With the NMPA approval of TaurusOne, the company is planning to start the commercialisation of TAVR products.
Peijia Medical’s second-generation TAVR product TaurusElite is currently in the registration stage, and its third-generation TAVR product TaurusNXT is in preclinical preparations.
Based in Suzhou, Jiangsu Province, the company has developed a product and solutions portfolio in the field of structural heart disease and cerebrovascular interventions in China.
