Core Insights - The completion of the TARGET confirmatory clinical study with 150 patients marks a significant milestone for Cardiovalve in the treatment of tricuspid regurgitation, advancing its path towards CE MDR approval [1][2] - Cardiovalve is a self-developed transcatheter replacement product that can treat both mitral and tricuspid regurgitation, offering enhanced safety and applicability for approximately 95% of patients [1] Group 1 - The TARGET confirmatory clinical study is a prospective, multi-center, single-arm study conducted across over 30 cardiovascular centers in Europe (mainly Germany, Italy, Spain), the UK, and Canada [1] - Cardiovalve features a unique design with a maximum 55mm valve ring and a short valve frame that effectively reduces the risk of left ventricular outflow tract obstruction [1] Group 2 - The board believes that the completion of the clinical trial is a major milestone for the product's market entry and represents significant progress in innovative therapies for tricuspid regurgitation globally [2] - The company aims to leverage its established advantages in research, production, and commercialization in the global structural heart disease field to expedite the clinical registration and approval of innovative products like Cardiovalve [2]
启明医疗-B：CARDIOVALVE TTVR确证性临床研究完成全部临床入组