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 suitability for approximately 95% of patients [1] - The company aims to leverage its established advantages in research, production, and commercialization in the global structural heart disease field to expedite the global clinical registration and approval of innovative products like Cardiovalve [2] Summary by Sections Clinical Study - 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, successfully enrolling 150 patients [1] - The study's completion is viewed as a major advancement in innovative therapies for tricuspid regurgitation on a global scale [2] Product Features - Cardiovalve features a unique design with a maximum 55mm valve ring, significantly improving treatment safety and reducing the risk of left ventricular outflow tract obstruction [1] - The product's operation is straightforward, requiring only three steps: positioning, anchoring, and releasing [1] Strategic Goals - The company is committed to advancing the global clinical registration development process for innovative products, including Cardiovalve, to benefit more patients and achieve its internationalization strategy [2]
启明医疗-B(02500)：CARDIOVALVE TTVR确证性临床研究完成全部临床入组