Cardionovum has announced positive initial results of a preclinical study and a first-in-man clinical study of its Primus Drug-Coated Balloon (DCB).
The study will be published in the October’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 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 revascularisation of the target lesion.
Authors of the publication include the principal investigator of the clinical trial, Carlo Briguori,Department of Cardiology, Clinica Mediterranea, Naples, Italy; and, Renu Virmani,president and medical director, CVPath Institute, Gaithersburg, who conducted the preclinical trial.
Researchers said: “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.
“The current study investigated the preclinical safety and clinical performance of a novel DCB catheter, which utilises 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 six months follow-up,” the authors concluded.