Cardionovum to introduce two DEB dilatation catheter product families

Cardionovum GmbH will launch two drug-eluting balloon (DEB) dilatation catheter product families at next week's EuroPCR 2012 congress: Paclitaxel-coated drug-eluting balloons for coronary (PRIMUS®) and peripheral (LEGFLOW®) applications.    

"We have developed an entirely new paradigm for selectively supplying only the drug to an arterial lesion site," said Michael Orlowski, M.D., CEO of Cardionovum. "Once an interventionalist has finished the dilatation and has withdrawn the balloon, virtually all of our drug-carrier-substance remains on the balloon itself."

With the proprietary Cardionovum gradient balloon coating technology, nanocrystalline Paclitaxel is embedded only under the surface of the top layer of a newly formulated shellolic acid drug-release-matrix. Efficient drug release, reproducibility and clinically superior drug in-tissue availability have been conclusively demonstrated in GLP preclinical trials. (Note: shellolic acid is FDA-cleared under category 'E 904' as a food additive. It is a natural resin, which is often applied in the pharmaceutical industry for film-coating of pills for control of pill dissolution.)

Preclinical testing was performed at CV Path Institute (Gaithersburg, USA) and validated that Cardionovum's DEB coating does not cause any noticeable micro-emboli, which classifies Cardionovum's DEBs to be as safe as any uncoated angioplasty balloon catheter relative to potential micro-embolies. Both safety features, integrity of the drug coating composition and non-occurrence of micro-emboli, increase the safety profile for operators and patients and fulfill safety requirements of regulatory authorities.

Cardionovum holds worldwide multiple priority patent-pending rights for its coating technology.

The Company's product pipeline includes: (1) Paclitaxel-coated RESTORE^® DEB, a novel drug-carrier-matrix that enables increased drug-in-tissue concentration, which is designed to widen the therapeutic window and result in an improved outcome for most patients with critical limb ischemia (CLI) and diabetic foot syndrome (DFS), as well as patients who have to undergo repeated interventions (e.g., diabetic patients) and patients with dialysis fistula stenosis. (2) Sirolimus-coated RENERGY^® DEB, for which it has been demonstrated conclusively in preclinical trials that this technology overcomes the commonly known difficulty of achieving a therapeutically effective drug-in-tissue concentration of Sirolimus with DEB. (3) A drug-eluting aortic valvuloplasty (DAVY) balloon catheter featuring a new formulation for ultra-fast drug-elution in just four seconds to the ring of the aortic valve for the treatment of patients for whom TAVI is counter-indicated or to delay the necessity for valve replacement by TAVI or open surgery.