German company Cardionovum GmbH has updated us with the news that its distribution network, covering 57 countries, is pressing ahead with the commercialisation of its Primus® paclitaxel-coated balloon based on preclinical and clinical support.
Last month we covered the news that Cardionovum had gained good results from preclinical and first in man studies of its Primus Drug coated balloon.
Following receipt of the CE mark, the Company started commercialising its paclitaxel-coated drug-coated balloon for coronary (Primus®) and peripheral (Legflow®) applications in March 2012. It also expects to launch before year-end a next-generation Sirolimus-eluting coronary stent system—Prolimus® Biograde, and says its design combines proven pro-healing features to promote early re-endothelialisation.
Primus is said to represent a new-generation of drug coated balloon with an innovative carrier matrix that facilitates effective transfer of paclitaxel to the arterial vessel wall. In preclinical studies at 28 days subjects showed sustained fibrin deposition, an indirect measurement of drug efficacy in arterial tissue that is associated with the protection of the treated vessel wall against smooth muscle cell proliferation. Notably, fibrin was absent at 28 days in control group vessels treated with another currently marketed equivalent product. Cardionovum claims these results support the conclusion that its coating results in a more persistent drug tissue effect.
Another clinically important result of the preclinical studies validated that Primus DCB dilatation, compared to DCBs 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 micro-emboli that may be associated with myocardial damage.
“We believe that Cardionovum is at the head of the class of interventional cardiology innovation,” said Michael Orlowski, M.D., CEO of Cardionovum. “We are confident about our growth prospects as we provide new clinical therapies for the successful treatment of coronary and endovascular artery diseases.”
Cardionovum’s products are not available for sale in the United States.
Source: Cardionovum GmBH., Business Wire