Peijia Medical has announced the initiation of its multicentre clinical trial for TaurusNXT, the third-generation transcatheter aortic valve implantation (TAVI) system, following the first successful patient implant in Zhongshan Hospital of Fudan University, Shanghai, China.
Led by Ge Junbo, the procedure was completed successfully with support from the medical team comprising Zhou Daxin, Pan Wenzhi, Zhang Xiaochun, Chen Shasha, and multidisciplinary teams including cardiology and cardiac surgery.
TaurusNXT is Peijia’s latest generation TAVI system with non-glutaraldehyde cross linked dry-tissue and pre-mounted prosthetic aortic valve (PAV). TaurusNXT incorporates the company’s non-glutaraldehyde treated anti-calcification technology, which is designed to result in the elimination or significant reduction of tissue calcification by removing residual aldehyde in the pericardium.
The clinical trial is a multicentre, prospective, single-arm objective performance criteria (OPC) study to evaluate the safety and efficacy of the TaurusNXT TAVI system for treating calcific severe aortic stenosis for National Medical Productions Administration (NMPA) registration.
The study is led by Ge Junbo from Zhongshan Hospital of Fudan University, and involves participation from more than 15 centres across China.
“As TAVI indication expands toward younger patients with longer life expectancy, our TaurusNXT system concentrates on ground-breaking innovations to address the most pressing issues, including durability and optimal clinical outcomes,” said Yi Zhang, chairman and CEO of Peijia Medical. “Ever since the establishment of Peijia, we have been continuously exploring innovative biotreatment technology for valve leaflets. We keep investing in the pioneering technology and have established a leading position in the field. The non-glutaraldehyde treatment technology of TaurusNXT has the potential to become a platform technology in advanced materials for the next generation of heart valves with longer durability.”