By Fineline Cube 
KingstronBio, a Changshu-based structural heart disease device manufacturer, has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its in-house developed Prostyle A transcatheter aortic valve replacement (TAVR) system. This innovative device marks a significant advancement in the treatment of aortic valve disease, offering a dry pre-installed, recyclable delivery system.
Prostyle A Valve: Technological Breakthrough
The Prostyle A valve stands out as the world’s first pre-installed dry valve, leveraging the globally leading anti-calcification platform Micro Ex. This advanced technology completely removes tissue debris while sealing off calcification sources during valve preservation, resulting in significantly improved valve durability. The innovative design addresses key challenges in traditional TAVR procedures, positioning KingstronBio at the forefront of structural heart disease interventions.
Clinical Trial Success and Performance Metrics
Clinical trials of the Prostyle A valve have demonstrated exceptional performance. Results indicate an average postoperative aortic valve pressure gradient of 12 mmHg at one-year follow-up, alongside a low pacemaker implantation rate of only 10.4%. These outcomes highlight the valve’s effectiveness and safety, reinforcing its potential to become a preferred solution for patients requiring transcatheter aortic valve replacement.-Fineline Info & Tech