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.