Cardiovalve Successfully Completes TARGET Study Patient Enrollment for CE Registration
Cardiovalve Completes Patient Enrollment in TARGET Study
On October 25, 2025, Venus Medtech (Hangzhou) Inc. announced a significant milestone in the field of cardiac therapy with the successful completion of patient enrollment in the Cardiovalve TARGET study. This endeavor, which is focused on the transcatheter tricuspid valve replacement (TTVR) system, has seen a total of 150 patients registered, marking a vital step towards securing European regulatory approval.
The completion of patient recruitment is a pivotal moment for Cardiovalve, as it prepares to submit its application for CE marking to European regulators by the end of the year. A successful CE mark approval would pave the way for the commercial launch of the Cardiovalve TTVR system, anticipated for 2027. This system represents a groundbreaking solution aimed at treating tricuspid regurgitation, a condition that can significantly impact patients' quality of life.
Future Steps
Building on the momentum of the TARGET study, Cardiovalve is also gearing up to initiate the AHEAD study, which aims to evaluate the safety and efficacy of its mitral valve replacement system in patients suffering from significant mitral insufficiency (MI). This study is crucial as it hopes to support a future application for CE marking for the mitral valve system, signaling Cardiovalve's commitment to expanding its innovative product offerings in cardiac care.
Participation in TCT 2025
In addition to its ongoing studies, Cardiovalve will present preliminary data from its mitral regurgitation (MR) system at TCT 2025. This presentation is expected to highlight advancements in transcatheter mitral valve replacement technologies and will be conducted by Dr. Christian Frerker.
- - Session Details
- Date: Tuesday, October 28, 2025
- Time: 12:25 PM - 12:30 PM
- Location: Moscone Center, North Hall, Innovation Theater
About Cardiovalve
Cardiovalve, a subsidiary of Venus Medtech, is at the forefront of transcatheter valve replacement technology and is committed to innovation in structural heart therapies. With over 150 approved patents and a highly skilled team, Cardiovalve aims to provide advanced solutions for physicians, enhancing patient outcomes without the need for open-heart surgery.
About Venus Medtech
Venus Medtech (Hangzhou) Inc. (2500.HK) stands as a leader in the innovation of transcatheter heart valve solutions for structural heart diseases. The company has developed a comprehensive product line that encompasses all four heart valves (TAVR, TPVR, TMVR, and TTVR) along with their access devices. With global R&D centers in China, the United States, and Israel, Venus Medtech is committed to delivering effective therapeutic solutions for life-threatening conditions.
Topics Health）
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