CARDIONOVUM Press Release: RESTORE® Drug-Coated Balloon Matches Zotarolimus-Eluting Stent in Patients with Coronary Small Vessel Lesions

For immediate release

San Diego 23 September, 2018 – The performance of RESTORE®, CARDIONOVUM’s innovative drug-coated balloon (DCB) for coronary applications, matches that of latest-generation zotarolimus-eluting stent in patients with coronary small vessel disease (SVD). This was demonstrated in the randomised controlled RESTORE SVD China trial presented at the Transcatheter Cardiovascular Therapeutics congress (TCT 2018) by Dr. Runlin Gao, Fuwai Hospital, Chinese Academy of Medical Science.

The trial was performed at 12 sites, enrolling 262 subjects with coronary small vessel lesions. Subjects were treated with RESTORE paclitaxel-releasing DCB or the Medtronic Resolute® zotarolimus-eluting stent. The primary analysis was non-inferiority of RESTORE on percent diameter restenosis at 9 months. This objective was met with high statistical significance (<0.001). There were also statistically similar rates of target-lesion failure at one year.

The trial included a substudy in patients with very small vessels (diameter between 2 mm and 2.25 mm). RESTORE was successfully employed in this population with a procedural complication rate of only 3% and no death, MI or thrombotic events. This makes RESTORE the first DCB with safety and angiographic efficacy evidence from a randomised controlled clinical trial in this vulnerable population. Currently, interventional cardiologists have few proven treatment options for very small diseased vessels.

Small vessel diameter is a strong predictor of restenosis and target-lesion failure after PCI, particularly with bare-metal stent or plain old balloon angioplasty.i In daily practice, at least 30% of percutaneous coronary interventions (PCI) involve small coronary vessels ii and rates of repeat revascularisation can exceed 25% in these individuals.

‘Our results add to the growing body of evidence of the benefit of DCB treatment in SVD’. The non-inferiority was met in percentage of diameter restenosis compared to RESOLUTE and the clinical results were also comparable between the two groups’, Dr. Runlin Gao said. ‘This provides the physicians with a new clinical option for the treatment of SVD and the concept of “intervention without implantation” could possibly be beneficial to the small vessels’

Enrolment into RESTORE SVD took only 10 months, which minimised the risk of bias and ensured that both treatment groups received up-to-date therapies. In the comparator group all subjects were treated with the latest-generation zotarolimus-eluting stent. Angiographic data were available for >80% of the study population.

‘I am very impressed by the stellar team of researchers who designed and carried out RESTORE SVD’, said Marina Izzo, CEO of CARDIONOVUM. ‘For DCB and RESTORE to become established as an option in SVD, evidence has to be of supreme quality. The RESTORE SVD trial met the highest international standards. Angiographic assessments were performed by an independent core lab including for patients with very small vessels. At CARDIONOVUM we believe passionately in our products and we are confident that physicians and patients will soon benefit from the results of this trial.’

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. It has demonstrated high success rates and excellent safety profile in coronary applications. RESTORE SVD China, which was sponsored by CARDIONOVUM, is the first trial with the RESTORE DCB in subjects with SVD.

RESTORE DCB was designed for ease of handling, high safety and precise drug delivery. This was confirmed by the high procedural success rates and the lack of significant differences in complications between RESTORE and Resolute. 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 SVD CHINA, sponsored by CARDIONOVUM, is one of the largest trials on RESTORE. It is part of the company’s large, ongoing clinical trials programme, which 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 uses 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.

About CARDIONOVUM

CARDIONOVUM, a medical technology company based in Bonn, Germany, develops and commercialises innovative medical devices such as new generation of DCB 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 Price et al, JACC: Cardiovascular Interventions 10, 1381–1388 (2017).

2 Ho & Ong, The Lancet (2018), doi:10.1016/S0140-6736(18)31926-3.