Cre8™ EVO Approval of CE Mark

Alvimedica today announced the CE mark of its new polymer free Amphilimus™ eluting stent, Cre8™ EVO.

 

Cre8™ EVO is a highly innovative Drug Eluting Stent (DES) that is designed to face the clinical outcome challenges when treating patients undergoing PCI. Innovation is the only way to further improve current clinical patient outcome. That is what Cre8™ EVO is; a DES born from the most innovative technology to date.

Cre8™ EVO, manufactured by CID S.p.A. member of Alvimedica group,  is a polymer-free stent providing a controlled elution of the Amphilimus™ formulation (a combination of Sirolimus and Fatty Acid) through the Abluminal Reservoir Technology which ensures the highest efficacy profile for the patient. The new stent architecture, together with the ground breaking Cre8™ EVO proprietary technology, has been conceived 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, provides high haemo- and bio-compatibility increasing the rate of strut coverage and thus potentially reducing thrombogenicity.

Upon the availability of Cre8™ EVO Alvimedica is soon starting the Diab8 randomized trial. It is an all comer study done in patients with diabetes mellitus where Cre8™ EVO is compared to Everolimus Eluting Stents. With the Diab8 randomized trial Alvimedica is planning to establish Cre8™ EVO as the gold standard DES for diabetic patients.

Leyla Alaton, president and CEO of Alvimedica, has commented: “We believe that Cre8™ EVO will be a big step forward in DES clinical outcome for all the diabetic patients undergoing PCIs. Here in Alvimedica we are committed to develop devices that answer the today un-met need in patient care in the coronary field”.

 

About Alvimedica

Alvimedica is a young, innovative company devoted to developing minimally-invasive technologies for medical professionals looking for the next level of innovation in the operating room. We firmly believe that working closely with physicians is the best way to improve our product solutions and services; our ‘co-creation approach’ results in an innovative endovascular product portfolio and in a range of products aimed at meeting needs so far unmet in interventional cardiology.

Alvimedica invites medical professionals to join its ambitions in creating best medical devices for people around the globe.

For more information about Alvimedica, please visit: www.alvimedica.com