Qiming Medical-B (02500): CARDIOVALVE TTVR confirmatory clinical study completed all clinical enrollment

Zhitong Finance App News, Qiming Medical-B (02500) issued an announcement. Recently, the European Confirmatory Clinical Study of Cardiovalve, the company successfully completed the enrollment of all 150 cases of transcatheter tricuspid valve replacement (TTVR) patients. This is yet another major development advance for Cardiovalve in the field of tricuspid reflux treatment, and marks an important milestone on the way to obtaining CE MDR.

The TARGET Confirmatory Clinical Study is a prospective, multicenter, single-arm study on patients with tricuspid valve reflux. The study was conducted at more than 30 cardiovascular centers in Europe (mainly Germany, Italy, Spain), the United Kingdom and Canada, and a total of 150 patients were enrolled.

Cardiovalve is a self-developed transcatheter interventional replacement product that can also be used to treat mitral valve reflux and tricuspid valve reflux. Compared with similar products, the Cardiovalve approach through the femoral vein significantly improves treatment safety. The maximum 55mm large valve ring design of the product is suitable for about 95% of patients. At the same time, its unique short valve holder design can effectively reduce the risk of ventricular outflow obstruction. The Cardiovalve is easy to operate, safe, and highly replicable. It only requires three steps: positioning, anchoring, and release.

The Board is convinced that Cardiovalve's completion of the European Confirmatory Clinical Trial to enroll all patients is a major milestone in its marketing process and a significant advance in innovative treatments for tricuspid valve reflux worldwide. With the advantages of R&D, production and commercialization established by the company in the field of structural heart disease around the world, the company will continue to actively promote the global clinical registration development process for innovative products, including Cardiovalve, and obtain early approval of competitive products, so that more patients can benefit and realize the company's internationalization strategy.