In short
German heart device company Cardionovum has announced commencement of its in vivo testing programme for its second drug-eluting balloon (DEB) Restore™.
Background
Cardionovum is currently marketing a line of CE-marked paclitaxel-coated DEBs for coronary and peripheral applications with its Primus® and Legflow® products respectively.
The company says the Restore family of DEBs is novel because of its unique, highly intense and so-called “EXPRESS” drug-release platform. The product was developed for the clinically efficient and successful treatment of patients who come back for repeat anti-proliferative treatment of restenosis.
Restore’s ‘PTX’ coating is claimed to ensure a biocompatible drug transfer into the arterial tissue under avoidance of micro emboli, which are often observed after application of other DEBs, as observed by Renu Virmani, M.D., CV Path Institute, USA.
Now the company has commenced an in vivo study to confirm the claim.
Company comments
“Restore complements our current DEB product portfolio with additional therapeutic capacities,” said Michael Orlowski, Ph.D., CEO of Cardionovum.
“Our core competence is in medical coating technologies. Our mission is to develop an entirely new paradigm for the safest and clinically most effective local drug delivery to the arterial lesion site,” added Dr. Orlowski. “ We believe that our novel approach to drug-coating is superior to existing products on the market, as we do not use plasticizer, nor uncontrollable toxic drug excipients, giving us a potentially dominant position in the emerging market for DEBs as first-line therapy for a wide variety of patients in need of coronary and peripheral vascular interventions.”
Regulatory status
Cardionovum’s products are not available for sale in the United States
Source: Cardionovum GmbH., Business Wire
