VENUS MEDTECH-B (02500) has released interim clinical results from the TARGET study for its innovative transcatheter valve replacement system, Cardiovalve. The TARGET study is a prospective, single-arm, multicenter clinical trial designed to evaluate the safety and clinical performance of the Cardiovalve system.
The interim data includes 125 patients with an average age of 77 from 25 clinical centers across Germany, Spain, Italy, Canada, and the UK. Key findings from the study include: 1. The average procedural time was 58±29 minutes, with the shortest procedure completed in just 16 minutes. 2. The overall intraoperative success rate was 88% according to the Tricuspid Valve Academic Research Consortium (TVARC) criteria, with a 95% success rate in the device implantation group.
Effectiveness results demonstrated: 1. 100% of patients showed no moderate or severe tricuspid regurgitation at 6-month follow-up, with stable outcomes maintained through 12 months. 2. 88% of patients achieved NYHA Class I/II cardiac function improvement at 6 months, increasing to 90% at 12 months. No NYHA Class IV cases were observed during follow-up. 3. Quality of life improvements included an average 20-point increase in Kansas City Cardiomyopathy Questionnaire scores at 6 months, sustained through 12 months. Six-minute walk distance improved by 44 meters at 6 months and 32 meters at 12 months.
Safety outcomes showed: - In the ITT subgroup, 26 subjects (20.8%) experienced Major Adverse Events (MAE) within 30 days post-procedure, with 14 subjects reporting two or more MAEs (41 total events).
The 12-month follow-up data confirmed Cardiovalve's favorable safety profile and clinical performance, with sustained quality-of-life improvements and stable low rates of safety events compared to 30-day results. Notably, 65.8% of enrolled patients received large-sized (55mm) prosthetic valves.
Presented at PCR London Valves 2025, these interim results demonstrate Cardiovalve's excellent clinical efficacy in treating severe tricuspid regurgitation, earning high recognition from international clinical experts. VENUS MEDTECH-B continues to advance global clinical registration for Cardiovalve and other innovative products, aiming to bring commercially competitive solutions to market for patient benefit and international expansion.