The Company Advances Toward European CE Mark Submission with 150 Patients Enrolled; On Track for 2027 Commercial Launch
HANGZHOU, China, Oct. 25, 2025 /PRNewswire/ — Venus Medtech (Hangzhou) Inc. (2500.HK, hereinafter referred to as the “Company”) today announced the successful completion of patient enrollment in the Cardiovalve TARGET study for Transcatheter Tricuspid Valve Replacement (TTVR), with a total of 150 patients enrolled. The completion of enrollment marks a major milestone toward European regulatory approval for Cardiovalve’s Transcatheter Tricuspid Valve Replacement (TTVR) system, the company’s flagship solution for treating tricuspid regurgitation.
With enrollment now complete, the company is preparing to submit its CE Mark application to European regulators later this year. Pending approval, commercial launch of the Cardiovalve TR system in Europe is projected for 2027.
Building on this achievement, Cardiovalve is also preparing to initiate its AHEAD study, which will evaluate the safety and performance of Cardiovalve’s mitral valve replacement system in patients suffering from significant mitral regurgitation (MR). The AHEAD study is designed to support a future CE Mark application for the mitral system.
Cardiovalve Participation at TCT 2025
Cardiovalve will present preliminary data for its mitral regurgitation (MR) system at TCT 2025.
The presentation, titled “Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System,” will be led by Dr. Christian Frerker.
Session Details:
- Session: Innovation Session 17 — New Generation Transcatheter Mitral Technologies: Case-in-a-Box Demonstrations
- Date: Tuesday, October 28, 2025
- Time: 12:25–12:30 PM
- Location: Moscone Center, North, Exhibition Level, Hall E- Innovation Theatre
About Cardiovalve
A subsidiary of Venus Medtech, Cardiovalve is a pioneer in transcatheter valve replacement technology, standing at the forefront of innovation in structural heart therapy. With more than 150 approved patents, a highly experienced team, and a state-of-the-art manufacturing facility, Cardiovalve is dedicated to providing physicians with next-generation solutions that improve patient outcomes and quality of life—without the need for open-heart surgery.
About Venus Medtech
Venus Medtech (Hangzhou) Inc. (2500.HK) is a leading innovator in transcatheter heart valve solutions for structural heart disease. The company has developed a comprehensive product pipeline covering all four heart valves — TAVR, TPVR, TMVR, and TTVR —and related accessory products. With global R&D centers in China, the United States, and Israel, The company is committed to providing effective treatment solutions for life-threatening diseases.
