Venus Medtech (Hangzhou) Inc. announced that Cardiovalve has submitted its CE technical dossier for the company’s transcatheter tricuspid valve replacement (TTVR) system to DEKRA, the notified body responsible for CE marking in Europe. The submission follows completion of the TARGET study, a 150-patient clinical trial evaluating the safety and performance of the Cardiovalve system.
The TARGET trial is a prospective, single-arm, open-label, multicenter study conducted across 30 sites in Europe, the UK, and Canada. Interim findings titled “Safety and performance of the cardiovascular valve replacement system for tricuspid regurgitation” were presented by Professor Georg Nickenig during the late-breaking clinical trials session at PCR London Valves.
Preliminary data published on November 16, 2025, showed that the Cardiovalve TTVR system substantially reduced tricuspid regurgitation (TR) in most participants. Notably, 73% of enrolled patients had massive or torrential TR at baseline.
The procedure demonstrated:
Patients will be followed for up to five years, with full clinical and echocardiographic results—including mortality and heart failure hospitalization rates—for all 150 patients expected to be released soon.
Professor Nickenig said the interim findings reflect “high efficacy in reducing tricuspid regurgitation and a favorable safety profile,” noting improvements associated with the latest device version.
Amir Gross, CEO of Cardiovalve, described the CE submission as a “fundamental milestone” that advances the system toward providing a new treatment option for patients with severe mitral and tricuspid regurgitation.
Venus Medtech CEO Lim Hou-Sen noted that, pending regulatory review, the company expects the Cardiovalve TR system to be positioned for commercial launch by 2027.
Cardiovalve, a subsidiary of Venus Medtech, develops transcatheter valve replacement technologies for structural heart disease. The company holds more than 150 patents and operates a dedicated manufacturing facility focused on minimally invasive valve therapies.
Venus Medtech (Hangzhou) Inc. (2500.HK) specializes in transcatheter solutions for structural heart disease and offers products covering all four cardiac valve types—TAVR, TPVR, TMVR, and TTVR—along with related accessories. The company conducts R&D in China, the United States, and Israel.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!