Significant Milestone for Cardiovalve's Heart Valve Programs
The Company Advances Toward European CE Mark Submission with 150 Patients Enrolled; On Track for 2027 Commercial Launch
Recently, Cardiovalve, a prominent player in transcatheter valve replacement technology, successfully completed patient enrollment for the groundbreaking Cardiovalve TARGET study focused on Transcatheter Tricuspid Valve Replacement (TTVR). This achievement, involving a total of 150 patients, represents a significant step towards obtaining European regulatory approval, a crucial milestone for the company.
The successful inclusion of these patients is a testament to the company's innovative approach and commitment to advancing treatment options for patients suffering from tricuspid regurgitation. With enrollment finalized, Cardiovalve is poised to submit its CE Mark application to European regulators, which is anticipated to occur soon.
If approved, the Cardiovalve TR system is projected to make its commercial debut in Europe by 2027, giving hope to many patients in need of effective valve replacement solutions.
The AHEAD Study: Paving the Way for Mitral Valve Innovations
In addition to the successful TARGET study, Cardiovalve is set to embark on the AHEAD study. This upcoming trial aims to evaluate the safety and effectiveness of their innovative mitral valve replacement system for patients facing significant mitral regurgitation (MR). The AHEAD study is strategically designed to support a future CE Mark application for this promising treatment, underscoring the company’s vision for comprehensive heart valve therapy.
Showcasing Innovations at TCT 2025
Cardiovalve is represented at prominent conferences to share its cutting-edge work. At TCT 2025, they will present early data regarding their mitral valve technology, specifically their mitral regurgitation (MR) system.
The presentation, titled "Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System," will be delivered by the esteemed Dr. Christian Frerker during the event.
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 and Venus Medtech
Cardiovalve, a subsidiary of Venus Medtech, is at the forefront of innovation in transcatheter valve replacement technology. With an impressive portfolio of more than 150 approved patents and a dedicated team, Cardiovalve works to enhance patient outcomes through state-of-the-art solutions that enable treatment without the necessity of open-heart surgery.
Venus Medtech (Hangzhou) Inc. (2500.HK) stands as a leader in the field of transcatheter heart valve devices for structural heart disease. The company’s extensive product lineup includes solutions for all four heart valves — TAVR, TPVR, TMVR, and TTVR — ensuring it meets a wide range of patient needs. With global research and development centers located in China, the United States, and Israel, Venus Medtech is dedicated to providing innovative solutions targeting life-threatening heart conditions.
Frequently Asked Questions
What is the Cardiovalve TARGET study?
The TARGET study is a clinical trial focused on Transcatheter Tricuspid Valve Replacement (TTVR) with the goal of providing a viable treatment option for tricuspid regurgitation.
How many patients were enrolled in the TARGET study?
A total of 150 patients were successfully enrolled in the TARGET study, marking an important milestone for the company.
What will happen after the TARGET study?
Once the study is completed, Cardiovalve plans to submit its CE Mark application for regulatory approval to market the TR system in Europe.
What is the projected commercial launch date for the TR system?
The commercial launch of the Cardiovalve TR system is expected in 2027, pending regulatory approval.
What other studies is Cardiovalve planning?
Cardiovalve is preparing to initiate the AHEAD study, which aims to evaluate the safety and performance of its mitral valve replacement system.
