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Publication of Preclinical and First-in-Man Clinical Trials Confirm “Excellent Device Performance with High Procedural Success and Absence of Clinical Events out to Six Months Follow-Up” with Cardionovum®’s PRIMUS Drug-Coated Balloon (DCB)

Wed, 09/19/2012 - 9:43am
The Associated Press

BONN, Germany--(BUSINESS WIRE)--Sep 19, 2012--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.

Authors of the publication include the principal investigator of the clinical trial, Carlo Briguori, M.D., Ph.D., Department of Cardiology, Clinica Mediterranea, Naples, Italy; and, Renu Virmani, M.D., President and Medical Director, CVPath Institute, Gaithersburg, Md., who conducted the preclinical trial: Their paper is titled: “From bench to bedside: Initial experience with the PRIMUS drug-coated balloon catheter,” and concludes: “The current study investigated the preclinical safety and clinical performance of a novel DCB catheter, which utilizes an innovative coating technology aimed at providing sustained drug effects in the treated vessel wall. Preclinical investigation showed an excellent performance in comparison with a contemporary DCB. First-in-man clinical experience confirmed excellent device performance with high procedural success and absence of clinical events out to 6 months follow-up.” The authors of the publication stated, “PRIMUS represents a new-generation DCB with an innovative carrier matrix that facilitates effective transfer of paclitaxel to the arterial vessel wall. It also should be noted that the PRIMUS DCB showed in the preclinical study sustained fibrin deposition, which is an indirect measurement of drug efficacy in arterial tissue and is associated with the protection of the treated vessel wall against smooth muscle cell proliferation, at 28 days; whereas, fibrin was absent at 28 days in control group vessels treated with another currently marketed DCB. These results support more persistent drug tissue effects with the PRIMUS DCB.” Another clinically important result of the preclinical study validated that Primus DCB dilatation, compared to DEBs that are coated with a highly water soluble drug excipient such as contrast media/PTX mixtures and other hydrophilic/drug balloon surface coatings, did not cause any noticeable microemboli that may be associated with myocardial damage.

About PRIMUS Cardionovum’s PRIMUS paclitaxel-coated coronary balloon dilatation catheter is coated with 3.0µg of paclitaxel/mm² balloon surface. The drug release matrix consists of a new formulation of the natural resin, shellolic acid. The PRIMUS DCB incorporates a novel “PTX-BOLUS” gradient coating technology. Paclitaxel is embedded sequentially underneath the top surface of its drug excipient matrix to ensure a highly condensed paclitaxel-bolus drug release during balloon inflation. As this novel PTX-BOLUS coating incorporates a hydrophobic drug release matrix, paclitaxel crystallization to the outside of the balloon surface is eliminated, unlike first-generation DCBs that use a highly water soluble drug release matrix, causing an unprotected and free PTX crystallization notable in the appearance of whitish PTX particles on the DEB balloon surface coating, which may fall or be wiped off during catheter manipulation and may contaminate the cath lab environment with toxic paclitaxel particles.

About Cardionovum Based on its breakthrough and proprietary ‘ PTX-BOLUS’ balloon-coated drug transfer technology, Cardionovum has developed and is commercializing in Europe clinically advanced medical therapies that are designed to improve upon current patient treatment standards for drug-eluting stents and drug-eluting balloons to treat coronary and peripheral artery disease.

NOTICE: Cardionovum’s products are not available for sale in the United States.

CONTACT: Cardionovum Ida Beerhalter, +49 (0) 611 – 7166578 beerhalter@cardionovum.eu KEYWORD: UNITED STATES EUROPE NORTH AMERICA MASSACHUSETTS GERMANY INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS MEDICAL DEVICES OTHER HEALTH MEDICAL SUPPLIES GENERAL HEALTH SOURCE: Cardionovum GmbH Copyright Business Wire 2012 PUB: 09/19/2012 09:43 AM/DISC: 09/19/2012 09:43 AM http://www.businesswire.com/news/home/20120919006138/

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