Alvimedica has received the CE mark for its new polymer-free amphilimus-eluting stent, Cre8 EVO.
Cre8 EVO is designed to provide a controlled elution of the amphilimus formulation (a combination of sirolimus and fatty acid) through its abluminal reservoir technology.
The new stent architecture, together with the Cre8 EVO proprietary technology, is intended to guarantee effective drug concentration within the vessel wall including complex coronary anatomies and pathologies like those of diabetic patients. The very thin cobalt chromium body, sealed by the Bio Inducer surface,is designed to provide high haemo- and biocompatibility increasing the rate of strut coverage and, according to a company release, potentially reducing thrombogenicity.
Upon the availability of Cre8 EVO, Alvimedica is to start the Diab8 randomised trial. It is an all-comer study of patients with diabetes mellitus, where Cre8 EVO will be compared to everolimus-eluting stents.