Please enter the keyword
The World's First Preassembled Dry-pericardium Transcatheter Aortic ValveHas Been Approved for Market Release

from clipboard

Recently, the PROSTYLE A® Transcatheter Aortic Valve System, a transformative research achievement jointly developed and commercialized by Prof. Chen Mao and Prof. Peng Yong's team from the Cardiology Department at West China Hospital of SCU, along with SCU alumnus Dr. Zhong Shengping has received market approval from the National Medical Products Administration (NMPA). As the world's first preassembled dry-pericardium transcatheter aortic valve, this product is designated for symptomatic patients with severe aortic stenosis and has been recognized as a national innovative medical device through special regulatory channels.

 

Utilizing dry-tissue valve techniques, this product features innovative preassembled and retrievable characteristics. It enhances clinical convenience while eliminating the risk of leaflet deformation caused by prolonged compression. Compared to conventional products, this breakthrough innovation preserves valve leaflets in a dry state without glutaraldehyde solution immersion, thereby reducing the risk associated with glutaraldehyde residues, improving biocompatibility, decelerating valve calcification, and extending device durability. Its preassembled design streamlines complex clinical preparation procedures during implantation, ensuring consistent quality control of valve loading while further mitigating product risks and enhancing clinical outcomes.

 

Prof. Chen Mao's and Prof. Peng Yong's team from the Department of Cardiology has long been committed to clinical and applied fundamental research in interventional therapies for valvular heart disease, consistently advancing the development and academic standards of transcatheter valve interventions in China. During this system's development, their team not only led the product's pivotal clinical trials as the principal investigator (PI) institution but also actively participated in product design optimization and foundational research including technical evaluations of the dry-tissue bovine pericardium.

 

This product exemplifies successful collaboration between West China Hospital and SCU alumni, fully demonstrating the profound clinical expertise of Cardiology Department and leveraging Kingstron Bio's specialized strengths in medical device R&D and manufacturing. Both parties will continue deepening cooperation to advance product upgrades, focus on clinical needs, and refine innovations in cardiac therapeutics. Committed to developing more high-quality, high-performance medical solutions, they aim to provide safer and more efficient treatments for patients in China and worldwide, driving the prosperity of global healthcare and restoring health to more patients.