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 ISR CHINA included 240 patients with coronary in-stent restenosis at 12 sites in China. A press release reports that the performance of RESTORE matched the best-in-class Sequent Please drug-coated balloon on both in-segment and in-device late lumen losses at nine months after the procedure, and on rates of target-lesion failure at one year.
RESTORE SVD CHINA was performed at 12 sites, enrolling 262 patients with coronary small vessel lesions. The press release states that, in this study, Restore was non-inferior to the latest-generation Resolute zotarolimus-eluting stent on percent diameter restenosis at nine months, as well as on rates of target-lesion failure at one and two years. In a substudy in patients with very small vessels (≥2.00mm and <2.25mm), Restore was successfully employed with a very low procedural complication rate and no death, myocardial infarction or thrombotic event. According to the press release, the results make Restore the first drug-coated balloon with strong evidence in this vulnerable population.
Xiaojie Chen (Zhuhai Cardionovum Medical Device and China Grand Pharmaceutical) comments: “I am extremely pleased by this approval. In-stent restenosis and small vessel disease are two urgent and challenging clinical areas in China. Powerful new therapies like Restore will help both physicians and patients.”
Marina Izzo, CEO of Cardionovum, comments: “At Cardionovum, we are passionate about driving the future and Restore is one of our most innovative products. I am very proud of the Chinese elite investigators whose hard work laid the foundation for this approval. Restore is the first and only drug-coated balloon available in China to treat small vessel disease. This is a great honour for us and a validation of our focus on performance-driven quality.”