CARDIONOVUM Press Release: RESTORE® Drug-Coated Balloon Matches Best-in-Class Device on Efficacy and Safety in Coronary in-Stent Restenosis
For immediate release
San Diego 23 September, 2018 – New clinical data show RESTORE®, CARDIONOVUM’s innovative paclitaxel-coated balloon for coronary applications, to match the best-in-class DCB Sequent® Please drug-coated balloon (DCB) on efficacy and safety for treating coronary in-stent restenosis (ISR). The results, from the randomised, controlled RESTORE ISR China trial, were presented by the primary investigator Dr Yundai Chen, PLA General Hospital, Beijing at the Transcatheter Cardiovascular Therapeutics congress (TCT 2018).
The researchers analysed 240 subjects with coronary ISR at 12 sites in China. The primary endpoint was in-segment late lumen loss of the target lesion 9 months after the procedure. The performance of the two treatments was statistically indistinguishable. Non-inferiority of RESTORE was proven by a large margin (p=0.02). The matching performance of RESTORE was valid for both in-segment and in-device late lumen losses. Both DCBs also showed statistically similar rates of target-lesion failure at one year (p=0.87 for the difference).
‘These positive trial results with RESTORE expand the range of DCB options in our patients with ISR’, said Dr Chen. ‘This is great news to physicians. The safety and manoeuvrability of RESTORE are especially relevant in cardiac applications. With RESTORE I feel in control of drug delivery to the target site with minimal risk for embolisation.
ISR is a common problem. More than 10% of patients who receive a drug-eluting stent can expect to suffer from the complication.i DCB treatment is highly appealing as a ‘leave nothing behind’ option that avoids introducing another layer of metal stent into the vessel.
‘I congratulate these experienced investigators to this successful ground-breaking trial’ said Marina Izzo, CEO of CARDIONOVUM. ‘The researchers designed and conducted RESTORE ISR China to the strictest international standards. At CARDIONOVUM we are committed to excellence in evidence to prove the value of our therapies. With RESTORE ISR China the team of investigators delivered highly reliable data, proving that RESTORE matches the best-in-class DCB for ISR. Physicians and patients world-wide will benefit from their efforts.’
RESTORE is a next-generation DCB that uses the proprietary SAFEPAX® next-generation coating matrix with the smallest particle size and highest coating stability on the market. The DCB was designed for ease of handling, high safety and precise drug delivery. The excellent safety profile was confirmed in RESTORE ISR: there were no procedure-related complications and no deaths during the 12 months follow-up. In two ISR trials and more than 160 patients,i complication rates with RESTORE have been shown to be less than 1%.
RESTORE ISR CHINA, sponsored by CARDIONOVUM, is one of the largest trials on RESTORE. It was designed to meet Chinese regulatory requirements and the successful outcomes pave the way for the introduction of RESTORE DCB into the Chinese market. The trial used the new-generation RESTORE DCB, which provides improved pushability and tensile resistance, as well as enhanced crossability and trackability. The new RESTORE DCB is being rolled out in 2018.
RESTORE ISR is part of CARDIONOVUM’s large, ongoing clinical trials programme. The programme started in late 2015 and to date includes >1300 patients with various vascular diseases.
About RESTORE® and SAFEPAX® technology
RESTORE is a paclitaxel-coated balloon for coronary applications, specifically designed for ease of handling, high safety and precise drug delivery. It utilises the next-generation SAFEPAX matrix, based on an ammonium salt compound, which promotes homogenous drug release. The coating matrix incorporates the smallest paclitaxel particles of all DCBs, for low drug loss rates, easy absorption into the vessel wall and reduced potential risk for microembolisation and myocardial injury.
CARDIONOVUM, a medical technology company based in Bonn, Germany, develops and commercialises innovative medical devices such as new generation DCBs and drug-eluting stents for the treatment of coronary and peripheral artery disease. The company’s pioneering range of DCBs is based on the SAFEPAX next-generation coating matrix which has the smallest particle size and highest coating stability on the market. The company’s strong commitment to clinical research ensures a continually deepening and expanding evidence base in support of the clinical benefits of our products.
1 Cassese S, et al. Heart. 2014;100:153–159.
2 Miglionico et al., Am. J. Cardiol. 116, 1690–1694 (2015)