Alvimedica's Cre8 Evo DES Receives CE Mark Approval
February 8, 2017—Alvimedica recently announced European CE Mark approval of its Cre8 Evo amphilimus-eluting stent, which is manufactured by CID SpA, a member of Alvimedica group.
After the launch of the Cre8 Evo device, Alvimedica will begin the all-comers Diab8 randomized trial comparing percutaneous coronary intervention in patients with diabetes mellitus using the Cre8 Evo device versus everolimus-eluting stents.
According to the company, Cre8 is a polymer-free stent that allows controlled elution of amphilimus (a combination of sirolimus and fatty acid) through its abluminal reservoir technology. The device is designed to provide effective drug concentration within the vessel wall including complex coronary anatomies and pathologies like those of diabetic patients. The very thin cobalt chromium body is sealed by the company's bio-inducer surface, which provides high hemo- and biocompatibility, increasing the rate of strut coverage and thus potentially reducing thrombogenicity.