Cardiovalve Completes Enrollment for TARGET Study Focused on Tricuspid Valve Replacement CE Approval
Cardiovalve Reaches Milestone: Completion of TARGET Study Recruitment
Venus Medtech (Hangzhou) Inc., through its subsidiary Cardiovalve, has announced a significant achievement with the completion of patient enrollment for its TARGET study dedicated to the Transcatheter Tricuspid Valve Replacement (TTVR) system. A total of 150 patients have participated, marking a crucial step toward obtaining the CE marking necessary for the system's European approval.
The recruitment phase, now concluded, sets the stage for the company to prepare its submission for CE marking to European regulatory authorities within the year. If all goes well and regulatory approval is granted, Cardiovalve anticipates launching its innovative TTVR system in Europe by 2027.
Next Steps: Preparing for AHEAD Study
In addition to gearing up for the CE marking application, Cardiovalve is also making preparations for its upcoming AHEAD study. This study will evaluate the safety and performance of the Cardiovalve mitral valve replacement system in patients suffering from significant mitral regurgitation (MR). The insights gained from this research are expected to support a future CE marking application for the mitral valve technology.
Cardiovalve at TCT 2025
Cardiovalve is set to present preliminary findings of its mitral regurgitation system at the upcoming TCT 2025 conference. The session, titled "Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System," will be led by Dr. Christian Frerker and will take place at the Moscone Center in San Francisco. This presentation is highly anticipated as it will showcase advancements in the company's technology.
Details of the Presentation
- - Session Title: Innovation Session 17 — New Generation Transcatheter Mitral Technologies Case-in-a-Box Demonstrations
- - Date: Tuesday, October 28, 2025
- - Time: 12:25 PM - 12:30 PM
- - Location: Moscone Center, North, Exhibition Level, Hall E - Innovation Theatre
About Cardiovalve
As a pioneering company in transcatheter heart valve technology, Cardiovalve focuses on developing innovative solutions addressing structural heart conditions. With more than 150 approved patents and a state-of-the-art manufacturing facility, Cardiovalve is committed to providing next-generation alternatives that enhance patient outcomes and quality of life, all while eliminating the need for open-heart surgery.
About Venus Medtech
Venus Medtech (Hangzhou) Inc., listed under ticker 2500.HK, is at the forefront of innovation within the field of transcatheter heart valve solutions aimed at treating structural heart diseases. The company has built a robust pipeline that covers all four heart valves — TAVR, TPVR, TMVR, and TTVR — along with associated accessory products. With global R&D centers located in China, the U.S., and Israel, Venus Medtech is dedicated to delivering effective treatment solutions for life-threatening diseases.
This remarkable development stands as a testament to Cardiovalve's commitment to transforming cardiac care and helping patients manage life-altering conditions through cutting-edge technology.
Topics Health）
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