Peijia Medical today announced the initiation of its multi-center clinical trial for TaurusNXT®, the third-generation transcatheter aortic valve ("TAVR") system, following the first successful patient implant in Zhongshan Hospital of Fudan University. Led by Professor Ge Junbo, the procedure was completed successfully with support from the medical team comprising Professor Zhou Daxin, Professor Pan Wenzhi, Professor Zhang Xiaochun, Professor Chen Shasha, and multidisciplinary teams including cardiology and cardiac surgery.
The patient was 71 years old, female, suffering from 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 mmHg and aortic valve peak velocity of 4.6 m/s. After evaluation by the team, the 20 mm Z-MED® balloon was used for pre-dilatation. 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. Since there was mild and more PLV after the valve was fully released, the 22 mm Z-MED® balloon was used for post-dilatation. Post-TAVR analysis was conducted immediately, indicating trace PVL, mean pressure gradient of 7 mmHg, aortic valve peak velocity of 1.9 m/s, aortic valve area of 2.0 cm2 as well as normal haemodynamics indicators.
TaurusNXT® is Peijia's latest generation TAVR system with non-glutaraldehyde cross linked dry-tissue and pre-mounted prosthetic aortic valve ("PAV"). It is another major breakthrough building on the Company's technological competences in structural heart diseases for nearly a decade. A number of Peijia's patents including biomaterial processing as well as overall system design are pending approval. TaurusNXT® incorporates the Company's world-leading non-glutaraldehyde treated anti-calcification technology. It results in the elimination or significant reduction of tissue calcification by removing residual aldehyde in the pericardium. The approach also optimizes the entire tissue functions through composite cross-link, decellularization, bio-degradation prevention and virus deactivation. The technology is expected to greatly enhance the durability and biocompatibility of the PAV. Furthermore, comparing to the traditional dry tissue technology using glycerin, Peijia adopts a low-temperature, freeze-drying technology to maintain the physical features of the tissue. The other significant benefit of dry PAV is to allow pre-mounted in the delivery catheter system ("DCS"), which greatly improves the operational efficiency.
The TaurusNXT® valve inherits the balanced performance of TaurusOne®, the Company's first generation TAVR system, and upgrades the design of stent structure, bioprosthesis position and double-layer skirt, in order to further improve the preformance of valve anchoring, sealing and hemodynamic. The DCS of TaurusNXT® adopts a patented catheter design for reliable and stable retrieval without sacrificing its flexibility to go through the aortic arch. It also features distal steerable function, which is expected to further enhance its coaxiality, transvalvular ability, and to address complex aortic arch and transverse heart morphological challenges safely and effectively. The TaurusNXT® system will hopefully further boost cardiologists' and surgeons' confidence with optimal implantation outcomes and better prognosis to patients.
The clinical trial is a multi-center, prospective, single-arm objective performance criteria ("OPC") study to evaluate the safety and efficacy of the TaurusNXT® TAVR system for treating calcific severe aortic stenosis for NMPA registration. The study is led by Professor Ge Junbo from Zhongshan Hospital of Fudan University, and involves participation from more than 15 top centers across China. "As TAVR indication expands toward younger patients with longer life expectancy, our TaurusNXT® system concentrates on groundbreaking innovations to address the most pressing issues, including durability an...
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