Chinese FDA approve Restore drug-coated balloon for in-stent restenosis and small vessel disease

Restore (Cardionovum), a paclitaxel-coated coronary balloon, now has Chinese market approval for in-stent restenosis and small vessel disease. The approval was given based on the results from two clinical studies in Chinese populations: RESTORE ISR CHINA and RESTORE SVD CHINA. RESTORE ISR CHINA and RESTORE SVD CHINA were both multicentre, randomised controlled trials. RESTORE [...]