The National Medical Products Administration (NMPA) has approved Venus Medtech (Hangzhou) Inc’s (HKG: 2500) transcatheter prosthetic pulmonary valve system for marketing, marking a milestone for the company’s innovative cardiac device.
Product Overview
The system comprises a self-expanding nickel-titanium alloy stent, porcine pericardium leaflets, and a delivery mechanism. The valve’s design enhances stent anchoring stability and accommodates a wide range of pulmonary valve annulus sizes, ensuring safer stent delivery and smoother blood flow. The delivery system’s compression loading mechanism improves valve loading efficiency and reduces radial collapse risks during deployment.
Clinical Indications
Approved for postoperative congenital heart disease patients aged ≥12 years and weighing ≥30kg with severe pulmonary regurgitation (≥3+), the device targets those with autologous right ventricular outflow tracts and specific clinical criteria.-Fineline Info & Tech
