Core Viewpoint - The mid-term clinical results of the Cardiovalve transcatheter valve replacement system from the TARGET study demonstrate its safety and clinical performance in treating severe tricuspid regurgitation, with positive feedback from international clinical experts at the PCRL London Valves 2025 conference [1][5]. Clinical Results - The TARGET study is a prospective, single-arm, multi-center clinical trial involving 125 patients across 25 centers in Germany, Spain, Italy, Canada, and the UK, with an average patient age of 77 years [1]. - The average procedure time for the device was 58±29 minutes, with the shortest recorded time being 16 minutes, and the overall procedural success rate was 88%, with a success rate of 95% in the device implantation group [1]. Efficacy Results - At the 6-month follow-up, 100% of patients showed no moderate or severe tricuspid regurgitation, with this efficacy maintained at the 12-month follow-up [2]. - According to the New York Heart Association (NYHA) classification, 88% of patients improved to NYHA class I/II at 6 months, increasing to 90% at 12 months, with no patients classified as NYHA class IV 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, with sustained efficacy at the 12-month follow-up, and the 6-minute walk distance increased by an average of 44 meters and 32 meters at 6 and 12 months, respectively [2]. Safety Results - The 30-day major adverse event (MAE) rates included an all-cause mortality rate of 6.4%, heart failure readmission rate of 1.6%, and a rate of 3.2% for re-intervention due to progression of tricuspid regurgitation or device-related complications [3]. - The study reported a 12.8% incidence of BARC type IIIb-V bleeding, with 5.6% experiencing major vascular injury at the puncture site [3]. - Among the 125 patients, 20.8% experienced MAEs within 30 days, with a total of 41 events reported [4]. Long-term Follow-up - The TARGET study's 12-month follow-up data indicate that Cardiovalve shows good safety and clinical performance, with sustained improvement in patients' quality of life and 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, and long-term follow-up data and global clinical evidence for Cardiovalve are still being collected [4]. Future Development - The company is committed to advancing the global clinical registration and development process for innovative products, including the Cardiovalve system, aiming for timely market approval to benefit more patients and achieve its international strategy [5].