First-in-Man Trials Point To Promising Performance From Novel Drug-Coated Balloon

In short

German cardiology company Cardionovum GmbH has trumpeted results from a soon-to-be published preclinical and first-in-man clinical study of its Primus Drug-Coated Balloon (DCB). Clinical study results point to high procedural efficacy and no adverse clinical events out to six months.


Cardionovum’s Primus 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 company claims its DCB incorporates a novel “gradient coating” technology which it calls “PTX Bolus”. What this means in effect is that 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. Furthermore the drug release matrix is ostensibly hydrophobic, which the company says eliminates the problem of crystallisation of the paclitaxel on the balloon surface.

The first-in-man study of 19 consecutive patients is to 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. It sought to assess clinical device performance in a small group of patients presenting with in-stent restenosis of drug eluting stents and results showed procedural success in all cases, with no deaths, and that no patient required revascularisation of the target lesion.

The paper is entitled: “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 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 6 months follow-up.”

Investigator comments

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.”

Regulatory status

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

Source: Cardionovum, Business Wire