Cardiovalve Submits CE Mark Application for Transcatheter Tricuspid Valve Replacement System Following Successful TARGET Study
Key Insights
Cardiovalve (search) has submitted its CE technical file to DEKRA (search) for European approval of its transcatheter tricuspid valve (search) replacement (TTVR) system following successful completion of the TARGET study with 150 patients enrolled.
The TARGET study demonstrated that the Cardiovalve (search) system effectively eliminated tricuspid regurgitation (search) in the majority of patients, despite 73% presenting with massive or torrential TR at baseline.
The procedure showed an acceptable safety profile with improvements in patient symptoms by 30 days post-treatment, with commercial launch projected for 2027 pending CE mark approval.
Venus Medtech (search)'s subsidiary Cardiovalve (search) has submitted its CE technical file to DEKRA (search), the European notified body, for approval of its transcatheter tricuspid valve (search) replacement (TTVR) system. The submission follows the successful completion of the TARGET study, which enrolled 150 patients across 30 sites in Europe, the UK, and Canada to evaluate the safety and performance of the Cardiovalve TR system (search).
TARGET Study Demonstrates Clinical Effectiveness
The TARGET study, a prospective, single-arm, open-label, multicenter clinical trial, showed promising results for treating tricuspid regurgitation (search). The interim results, presented by Prof. Georg Nickenig at PCR London Valves 2025, demonstrated that the Cardiovalve (search) system effectively eliminated tricuspid regurgitation in the majority of patients, despite 73% presenting with massive or torrential TR at baseline.
"The results of the Cardiovalve (search) study are highly encouraging, demonstrating strong efficacy in tricuspid regurgitation (search) (TR) reduction and a favorable safety profile, particularly with the new device iteration," said Prof. Georg Nickenig. "These findings represent an important step forward, offering hope that patients suffering from TR will soon have access to a novel and effective treatment option."
Safety Profile and Patient Outcomes
The procedure demonstrated an acceptable safety profile, with improvements in patients' symptoms observed by 30 days post-treatment. Patients enrolled in the study will continue to be followed for up to five years, with comprehensive clinical and echocardiographic outcomes, including mortality and heart failure hospitalizations from the full 150-patient cohort, to be presented in the near future.
Commercial Timeline and Future Development
With the CE submission now under review, Cardiovalve (search) is positioned to achieve certification and begin commercial rollout of the TR system by 2027. "The submission of the CE file marks a pivotal milestone and brings Cardiovalve closer to delivering transformative therapy for patients suffering from severe mitral and tricuspid regurgitation (search)," said Amir Gross, CEO of Cardiovalve.
Building on this achievement, Cardiovalve (search) is also preparing to initiate its AHEAD study, which will evaluate the safety and performance of Cardiovalve's mitral valve (search) replacement system in patients suffering from significant mitral regurgitation (search). The AHEAD study is designed to support a future CE Mark application for the mitral system.
Company Background
Cardiovalve (search), a subsidiary of Venus Medtech (search) (2500.HK), is a pioneer in transcatheter valve replacement technology with more than 150 approved patents. Venus Medtech has developed a comprehensive product pipeline covering all four heart valves — TAVR, TPVR, TMVR, and TTVR — with global R&D centers in China, the United States, and Israel.
Lim Hou-Sen, CEO of Venus Medtech (search), stated: "These promising results mark a significant advancement for patients suffering from tricuspid regurgitation (search). With the CE submission under review, Cardiovalve (search) is well-positioned to achieve certification and begin commercial rollout of the TR system by 2027."