Salute e Benessere
Cardiovalve Submits CE File for Approval Following Successful TARGET Study Completion
: "Safety and Performance of the Cardiovalve Replacement System for Tricuspid Regurgitation" were presented yesterday by Prof. Georg Nickenig , on behalf of the TARGET study investigators, during the Top Late-Breaking Trials session at PCR London valves Main Arena.
The TARGET Study followed 150 patients across 30 sites in Europe , the UK, and Canada as part of a prospective, single-arm, open-label, multicenter clinical trial, designed to evaluate the safety and performance of the Cardiovalve TR System.
The study interim results, published on Nov.16th,2025, showed that Transcatheter Tricuspid Valve Replacement (TTVR) with the Cardiovalve System effectively eliminated tricuspid regurgitation (TR) in the majority of patients, despite 73% presenting with massive or torrential TR at baseline, demonstrating the clinical effectiveness of the device in patients.
In addition to endpoints for efficacy, the procedure was observed to have an acceptable safety profile, with improvements in patients' symptoms by 30 days post-treatment.
Patients enrolled in the study will continue to be followed for up to five years. Comprehensive clinical and echocardiographic outcomes, including mortality and heart failure hospitalizations from the full 150-patient cohort, will be presented in the near future.
: "These promising results mark a significant advancement for patients suffering from tricuspid regurgitation. With the CE submission under review, Cardiovalve is well-positioned to achieve certification and begin commercial rollout of the TR system by 2027."
A subsidiary of , is a pioneer in transcatheter valve replacement technology, standing at the forefront of innovation in structural heart therapy. With more than , a highly experienced team, and a , Cardiovalve is dedicated to providing physicians with next-generation solutions that improve patient outcomes and quality of life—without the need for open-heart surgery.
is a leading innovator in transcatheter heart valve solutions for structural heart disease. The company has developed a comprehensive product pipeline covering all four heart valves — —and related accessory products. With global R&D centers in China , the United States , and Israel , the company is committed to providing effective treatment solutions for life-threatening diseases.
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