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REGISTERED CLINICAL DATA OF TaurusElite® AND TaurusTrioTM DEBUT AT PCR-CCV 2024
2024-09-24 16:48:34

During September 20-22, 2024, Peijia presented multiple clinical data at the PCR-CIT China Chengdu Valves (PCRCCV2024).

 ❖ 3-Year Follow-up Results of the TaurusElite® Registration Clinical Trial for Treating Aortic Stenosis (AS)

 Professor Xu Kai from the General Hospital of the Northern Theater Command of the Chinese People's Liberation Army shared the 3-year follow-up results of the TaurusElite® registration clinical trial for treating AS. This prospective, multicenter, single-arm target value study (35%) included 81 patients with AS who underwent TaurusElite® TAVR, with an average age of 76.6 years at baseline and an average STS score of 8.52%±3.52%, belonging to high surgical risk patients. 

The 3-year postoperative follow-up results showed that the all-cause mortality rate was 18.7% (14/75), with only 3 cases being cardiac deaths. The incidence of severe stroke and myocardial infarction was only 0.0% (0/66) and 1.5% (1/66), respectively. The incidence of surgical reintervention and valve-in-valve surgery was only 2.9% (2/68) and 4.9% (4/81). The patients' cardiac function continued to improve postoperatively, with 94.5% having NYHA functional classification I/II at 3 years, and the quality of life (EQ-5D) score showed continuous improvement, fully confirming the safety and effectiveness of this domestically produced TAVR valve.

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 ❖ 6-Month Follow-up Results of TaurusTrioTM which is Dedicated Transfemoral TAVR Device for Pure Aortic Regurgitation (AR) in Domestic Registered Clinical Study Professor Song Guangyuan from Beijing Anzhen Hospital, Capital Medical University, shared the 6- month follow-up results of TaurusTrioTM in domestic registration clinical study. 

Professor Song Guangyuan from Beijing Anzhen Hospital, Capital Medical University, shared the 6- month follow-up results of TaurusTrioTM in domestic registration clinical study. This is a prospective, multicenter, single-arm target value study that enrolled 116 AR patients across 19 centers, aiming to evaluate the safety and effectiveness of TaurusTrioTM for treating symptomatic, severe (≥3+) AR patients who are not suitable for conventional surgical procedures. All patients have been enrolled and have completed the 6- month postoperative follow-up.

At baseline, the average age of the patients was 71.9 years, with an average STS score of 5.6%±2.2%, severe AR accounted for 82.8%, and moderate-to-severe AR accounted for 17.2%. 

The 30-day postoperative follow-up results showed a device success rate of 100%, a procedural success rate of 95.7%, a 30-day all-cause mortality rate of 0%, a stroke incidence of 0.9% (1 case), a major bleeding incidence of 0.9% (1 case), a devicerelated surgery/reintervention incidence of 0.9% (1 case), and a moderate or greater paravalvular leak incidence of 0%.

The 6-month echocardiographic follow-up results showed that the average transvalvular pressure gradient decreased from 8.3 mmHg at baseline to 4.5 mmHg, and all patients' paravalvular leaks were reduced to mild or less. Significant left ventricular reverse remodeling was observed, along with significant improvements in cardiac function and quality of life.

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