Peijia Medical’s Third-Generation TaurusNXT TAVR Device Studied in China for Regulatory Approval

September 14, 2021—Peijia Medical announced the initiation of its multicenter clinical trial for the TaurusNXT, the company’s third-generation transcatheter aortic valve replacement (TAVR) system, which features nonglutaraldehyde cross-linked dry-tissue and a premounted prosthetic aortic valve.

Peijia Medical stated that the clinical trial is a multicenter, prospective, single-arm objective performance criteria study to evaluate the safety and efficacy of the TaurusNXT TAVR system for treating calcific severe aortic stenosis for registration with China’s National Medical Products Administration. The study will involve participation from more than 15 top centers across China.

The study is led by Professor Ge Junbo, MD, from Zhongshan Hospital of Fudan University in Shanghai, China. Prof. Junbo led the team at Zhongshan Hospital that conducted the first successful implant in the study.

According to the company, the patient was a female in her early 70s with severe aortic valve stenosis. Analysis of imaging examination indicated aortic valve thickening and calcification, tricuspid aortic valve, severe degree calcification (HU850: 722 mm³) with aortic valve area of 0.7 cm², mean pressure gradient of 53 mm Hg, and aortic valve peak velocity of 4.6 m/s.

After evaluation by the team, predilatation done with a 20-mm Z-Med balloon (B. Braun Interventional Systems). During the procedure, the valve was retrieved three times to ensure an optimal valve anchoring position before the AV26 TaurusNXT was implanted at zero position.

Because there was mild and more paravalvular leakage after the valve was fully released, the 22-mm Z-Med balloon was used for postdilatation. Post-TAVR analysis was conducted immediately, indicating trace paravalvular leak, mean pressure gradient of 7 mm Hg, aortic valve peak velocity of 1.9 m/s, aortic valve area of 2 cm², as well as normal hemodynamics indicators, advised Peijia Medical.