APERTO OTW® Drug Coated Balloon receives first Chinese NMPA Medical Device Registration Certificate for High Pressure DCB for Vascular Access
APERTO®, our innovative paclitaxel coated balloon for arterio-venous access, has received market approval for China. It is the the first high pressure drug coated balloon available in China to treat obstructive lesions of native Arterio Venous Dialysis Fistulae.
The approval was given based on the statistic results from the solidly designed clinical study in Chinese population:
APERTO AVF RCT CHINA.