The EUROLIMUS™ Sirolimus eluting coronary stent system is made of a coated cobalt-chromium alloy (L605) stent and a rapid-exchange catheter. Eurolimus is indicated for use in patients with symptomatic ischemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries. The stent system is also indicated for the treatment of acute or suspected occlusions in patients who respond unsuccessfully to an interventional therapy following balloon dilatation.
Eurolimus™ relies on a novel sterilization method via Electron Beam. The product is sterilized completely dry while utilizing direct current or linear accelerator to emit high energy electrons. Through this technique each DES is sterilized without any prior degradation of the product taking place. As a result Eurolimus™ achieves an exceptional 3 year shelf life.
Eurolimus™ DES offers an ultra thin stent strutdesign of 62 μm struts achieving excellent crossability and a low profile (0.97 mm for expansion-Ø 3.0 mm). Thinner struts afford not only greater flexibility and, hence, greater deliverability, but also reduce stent-induced arterial injury and inflammation and facilitate faster endothelialization.
The stent design further combines a 9-crown structurewith interlinks in order to achieve optimized vessel coverage, reduce local force and increase the overall vessel adaption.
The Sirolimus drug is formulated in a special polymer coating which guarantuees controlled release through the healing period following coronary intervention. A simultaneous polymer resorption and drug release takes place within 3-4 months to match the procedure–triggered biological response. As a result, EUROLIMUS™ achieves drug release over the entire restenotic cascade.
The sirolimus is formulated in a PLGA 85/15 poly(lactide-co-glycolide) Coplymere coating. Both substances – the copolymer and also the homopolymers – are generally considered as non toxic and biocompatible. The two natural materials are fully decomposed to water and carbon dioxide between 10-13 weeks.
The coating solution is applied to the stent through asymmetric coating. Here, the thickness of the coating layer is reduced on the luminal side of the device compared to an increased amount on the abluminal side. This asymmetric coating technique is balanced around optimal drug transfer to the vessel.
The proven long – term efficacy and Safety of the Eurolimus DES System was observed in two completed Studies on real world patients undergoing percutaneous coronary intervention in Europe.
The second-generation DES shows superioriority to first-generation DES in reducing stent thrombosis.
