Cardiovalve Reaches Significant Milestone in TARGET Study
The Company Advances Toward European CE Mark Submission with 150 Patients Enrolled; On Track for 2027 Commercial Launch
HANGZHOU, China — Venus Medtech (Hangzhou) Inc. (2500.HK, hereinafter referred to as the "Company") has successfully completed the enrollment of patients in the Cardiovalve TARGET study for Transcatheter Tricuspid Valve Replacement (TTVR), reaching a total of 150 patients enrolled. This achievement signifies a critical step forward in seeking European regulatory approval for the Cardiovalve's Transcatheter Tricuspid Valve Replacement (TTVR) system, which is their primary solution designed to treat tricuspid regurgitation.
With the enrollment phase concluded, the Company is preparing to file its CE Mark application with European regulators by the end of the year. If approved, the commercial launch of the Cardiovalve TR system in Europe is anticipated for 2027.
Upcoming AHEAD Study for Mitral Valve Replacement
In addition to this success, Cardiovalve is gearing up to commence its AHEAD study, which will investigate the safety and performance of its mitral valve replacement system for patients suffering from significant mitral regurgitation (MR). This study is crucial as it will pave the way for a future CE Mark application for the mitral system.
Participation in TCT 2025
Cardiovalve is set to present preliminary findings regarding its mitral regurgitation (MR) system during the prestigious TCT 2025 conference.
The presentation, aptly named "Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System," will be led by the esteemed 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 leading the way in transcatheter valve replacement technologies and is committed to advancing the field of structural heart therapy. Armed with over 150 approved patents, a team of seasoned professionals, and a state-of-the-art manufacturing facility, Cardiovalve is focused on equipping physicians with cutting-edge solutions that enhance patient outcomes and elevate quality of life without necessitating open-heart surgery.
Overview of Venus Medtech
Venus Medtech (Hangzhou) Inc. (2500.HK) stands as a pioneer in the space of transcatheter heart valve solutions targeted at structural heart disease. The company has cultivated a diverse product pipeline that encompasses all four heart valves — TAVR, TPVR, TMVR, and TTVR — along with associated accessory products. With research and development centers strategically located in China, the United States, and Israel, the company strives to deliver effective treatment alternatives for life-threatening conditions.
Frequently Asked Questions
What is the Cardiovalve TARGET study?
The TARGET study is a clinical trial aimed at assessing the effectiveness of Cardiovalve's Transcatheter Tricuspid Valve Replacement system in treating patients with tricuspid regurgitation.
How many patients were enrolled in the TARGET study?
A total of 150 patients were enrolled in the TARGET study, which has now completed enrollment.
What are the next steps for Cardiovalve?
Cardiovalve plans to submit its CE Mark application in the coming months and aims for a commercial launch of the Cardiovalve TR system in 2027.
What will the AHEAD study focus on?
The AHEAD study will evaluate the safety and performance of Cardiovalve's mitral valve replacement system in patients with significant mitral regurgitation.
When will Cardiovalve present its findings at TCT 2025?
Cardiovalve will present preliminary data on October 28, 2025, at TCT 2025 during the Innovation Session 17.
