BONN, Germany--(BUSINESS WIRE)--Cardionovum GmbH announced today that the results of a preclinical study and a first-in-man clinical study of its PRIMUS Drug-Coated Balloon (DCB) will be published in next month’s issue of Minerva Cardioangiologica, the Official Journal of the Italian Society of Angiology and Vascular Pathology and of the Italian Society of Vascular Diagnostics. Clinical study results in 19 consecutive patients presenting with in-stent restenosis (ISR) of drug-eluting stents showed that treatment with the PRIMUS DCB resulted in “high procedural efficacy,” and “there were no adverse clinical events observed out to six months.” The first-in-man clinical study sought to assess clinical device performance in a small group of patients; its results showed procedural success in all cases, with no deaths, and that no patient required revascularization of the target lesion.
