October 27, 2019
Cardionovum's Restore DCB Approved in China for In-Stent Restenosis and Small Vessel Disease
October 28, 2019—Cardionovum GmbH and China Grand Pharmaceutical and Healthcare Holdings Ltd. announced that Cardionovum's Restore paclitaxel-coated balloon for coronary applications has received market approval for China. The device is approved in China for treating two indications: in-stent restenosis (ISR) and small vessel disease (SVD).
The Restore device features the company’s SafePax next-generation, stable, homogeneous, paclitaxel coating. SafePax is an amorphous, noncrystalline matrix that is not affected by mechanical stress due to elastic, lipophilic, polymeric excipients.
According to the companies, the approval is supported by results from two multicenter, randomized controlled trials in Chinese populations: RESTORE ISR CHINA and RESTORE SVD CHINA.
RESTORE ISR CHINA was composed of 240 patients with coronary ISR at 12 sites in China. The performance of the Restore DCB matched the Sequent Please DCB (B. Braun Interventional Systems, Inc.) on both in-segment and in-device late lumen losses at 9 months after the procedure and on rates of target lesion failure at 1 year.
RESTORE SVD CHINA enrolled 262 patients with coronary small vessel lesions at 12 sites. In the study, the Restore DCB was noninferior to the latest-generation Resolute zotarolimus-eluting stent (Medtronic) on percent-diameter restenosis at 9 months, as well as on rates of target lesion failure at 1 and 2 years.
In a substudy of patients with very small vessels (≥ 2.00 mm and < 2.25 mm), Restore was successfully employed with a very low procedural complication rate and no death, myocardial infarction, or thrombotic events.