MicroPort Scientific Corp., a leading Chinese medical device company (HKG: 0853), through its spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has announced that it has received market approval for its heart valve balloon dilatation catheter, Alwide Plus, from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) in Mexico. This regulatory clearance allows for the commercialization of Alwide Plus in the Mexican market, expanding the product’s global reach.
Alwide Plus, an enhanced version of MicroPort CardioFlow’s original Alwide balloon catheter which gained marketing approval in China in July 2021, has already been registered in several countries including Argentina, Colombia, Brazil, Thailand, Russia, Indonesia, Saudi Arabia, and Hong Kong, China. The product has made significant inroads, accessing approximately 700 core hospitals worldwide.
In addition to the Alwide series, MicroPort CardioFlow’s third-generation valve balloon dilatation catheter, AccuSniper, has been commercialized and has received marketing approval in China, further solidifying the company’s position in the field of cardiovascular medical devices.
The market approval of Alwide Plus in Mexico is a testament to MicroPort CardioFlow’s commitment to innovation and quality, offering advanced cardiovascular solutions to patients globally.- Flcube.com