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RESTORE® Drug-Coated Balloon receives first Chinese FDA medical device registration certificate for two indications

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.