Cardionovum to introduce PROLIMUS Biograde system in Europe

Cardionovum GmbH announced today that it expects to launch in Europe in Q4 2012 a next-generation Sirolimus-eluting coronary stent system—PROLIMUS Biograde—which is designed to optimize long-term patient results. Unlike many state-of-the-art DES that are currently being marketed, PROLIMUS Biograde provides multiple pro-healing product features to promote early re-endothelialization.

The thin-stent strut design of PROLIMUS Biograde, just 71 microns, minimizes stent-metal-volume, and thus foreign-body effects, while providing uniform stent coverage through its strut architecture. In addition, the PROLIMUS Biograde stent architecture incorporates a diameter-depending 6-8-10 intermediate and closed-cell stent design intended to cover all vessel diameters with the same ratio. The goal of such design is to ensure a homogenous drug elution into the arterial tissue of the stented lesion segment.

Furthermore, Cardionovum´s new DES is designed to protect allergic patients against emission of metal ions. PROLIMUS Biograde 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 this "following nature" stent philosophy of Cardionovum. Most coronary stent systems now available do not combine all of these clinically advantageous features, which contribute to lower restenosis complication.

"It is not only the drug on a stent that counts for the optimal patient treatment," said Michael Orlowski, Ph.D., CEO of Cardionovum. "It also is critically important what remains in the patient´s artery for the patient´s lifetime, after drug elution has gone."

The clinically anti-proliferative drug Rapamycin (Sirolimus) is coated onto PROLIMUS Biograde with the natural and biodegradable polylactide acid (PLA) polymer. Due to the controlled, six-weeks drug release, the long-term inhibition of re-endothelialisation is successfully eliminated. The new PROLIMUS Biograde DES 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.