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.
RESTORE®, CARDIONOVUM’s innovative paclitaxel-coated balloon for coronary applications has received market approval for China, making it the first drug-coated balloon (DCB) available in China to treat two indications: in-stent restenosis (ISR) and small vessel disease (SVD). The approval was given based on the impressive results from two solidly designed clinical studies in Chinese populations: RESTORE ISR CHINA and RESTORE SVD CHINA.