MicroPort CardioFlow said its Alwide Plus balloon catheter has received CE mark approval, clearing the company to market the device in Europe.
The approval makes Alwide Plus the company’s fourth product authorized in Europe, following the VitaFlow Liberty transcatheter aortic valve and delivery system, and the AnchorMan left atrial appendage closure system with its access system.
Alwide Plus is used in transcatheter aortic valve implantation (TAVI) procedures. The balloon catheter has been introduced in more than 10 countries, including China, Brazil, Thailand, Russia, and Mexico.
MicroPort CardioFlow designed Alwide Plus with ultra-low compliance for precise balloon dilation and high burst pressure for use in severely calcified anatomies. The catheter also allows for rapid inflation and deflation to shorten pacing time and reduce procedural risk.
With the CE Mark, the company said Alwide Plus will provide European physicians with an additional option for TAVI procedures and support the commercialization of VitaFlow Liberty in Europe. CardioFlow said the approval also strengthens its global regulatory strategy and expands its portfolio of structural heart products.
