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.

 

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Cardiac Interventions Today is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007, with its launch issue focusing on the state of coronary drug-eluting stent use. Each edition will cover a variety of topics in a flexible format that includes articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's cardiology practices.