Cardionovum announced on 9 October 2012 that it has established its distribution network in 57 countries outside the United States since the beginning of the year.
The company has been commercialising its CE-marked paclitaxel-coated drug-coated balloon for coronary (Primus) and peripheral (Legflow)applications since March 2012. Additionally, Cardionovum expects to launch its next-generation sirolimus-eluting coronary stent system, Prolimus Biograde, with a design that combines proven pro-healing features to promote early re-endothelialisation, by the end of the year.
“We believe that Cardionovum is at the head of the class of interventional cardiology innovation,” said Michael Orlowski, 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.”
Primus represents a new-generation of drug-eluting balloons with an innovative carrier matrix that facilitates effective transfer of paclitaxel to the vessel wall. In preclinical studies, Primus showed sustained fibrin deposition at 28 days, whereas fibrin was absent at 28 days in control group vessels treated with another currently marketed drug-eluting balloon.
“Another clinically important result of the preclinical studies validated that dilatation with Primus, compared to drug-eluting balloons 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,” Cardionovum said.
The company added, “The Prolimus Biograde stent is coated with titanium, which is highly biocompatible and functions as a barrier against ‘metal-ion-bleeding’ that prevents any stent-associated hypersensitivity reaction. Especially high-risk patients such as diabetics will benefit from the Cardionovum device. The clinically anti-proliferative drug rapamycin (sirolimus) is coated onto Prolimus Biograde with a natural and biodegradable polymer. Due to the controlled, six-week drug release, the long-term inhibition of re-endothelialisation is successfully eliminated. The new Prolimus Biograde drug-eluting stent technology promotes early re-endothelialisation and rapid healing. Its pro-healing titanium stent surface promises long-term patient safety. The entire composition of all technical elements is designed to allow for a reduction of oral antiplatelet therapy in favor of the patient´s quality of life after stenting.”