Core Insights - The TARGET study demonstrates the safety and clinical performance of the Cardiovalve transcatheter valve replacement system, with positive mid-term clinical results [1][5] Efficacy Results - 100% of patients showed no moderate or severe tricuspid regurgitation at 6 months, with sustained efficacy at 12 months [2] - 88% of patients improved to NYHA functional class I/II at 6 months, increasing to 90% at 12 months, with no NYHA class IV patients observed during the 6-month follow-up [2] - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 20 points at 6 months, maintained at 12 months; 6-minute walk distance increased by an average of 44 meters at 6 months and 32 meters at 12 months [2] Safety Results - The overall major adverse event (MAE) rate within 30 days post-surgery was 20.8%, with 41 total events reported among 26 patients [3][4] - The all-cause mortality rate was 6.4%, with heart failure readmission at 1.6% and re-intervention due to tricuspid regurgitation progression at 3.2% [3] - The study reported a 12.8% incidence of BARC IIIb-V bleeding events, with 5.6% vascular injury at the puncture site [3] Long-term Follow-up - The TARGET study indicates that Cardiovalve shows good safety and clinical performance over 12 months, with a stable low incidence of safety events compared to the 30-day follow-up [4] - 65.8% of enrolled patients received a large-sized (55mm) prosthetic valve, with ongoing accumulation of long-term follow-up data and global clinical evidence [4] Industry Recognition - The mid-term clinical data presented at the PCR London Valves 2025 conference highlighted the Cardiovalve system's exceptional clinical efficacy in treating severe tricuspid regurgitation, receiving high recognition from international clinical experts [5] - The company aims to advance the global clinical registration and development process for innovative products, including the Cardiovalve system, to benefit more patients and achieve its international strategy [5]
启明医疗-B(02500)公布创新经导管瓣膜置换系统Cardiovalve的TARGET研究中期临床结果