Alvimedica today announced the completion of the enrolment of the ILLUMINA study
Friday March 3rd 2017
Alvimedica is proud to announce that the Illumina study enrolment is complete. The Illumina study has been designed to evaluate the efficacy and safety of the new self-expanding polymer free drug eluting stent - NiTiDES - for SFA manufactured by CID S.p.A. member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug elution (2-3 months) with a polymer-free nitinol platform.
Illumina is a prospective and single arm study, which enrolled 100 patients with ischemic obstruction of SFA and proximal popliteal artery. The two co-primary endpoints for the study are primary patency rate at 12 months - efficacy endpoint, and composite event free survival rate at 12 months - safety endpoint. The trial principle investigator is Prof. Dierk Scheinert from Leipzig University hospital.
NiTiDES is a polymer free stent eluting the Amphilimus™ formulation (a combination of Sirolimus and Fatty Acid) through the Abluminal Reservoir Technology aiming at obtaining the highest efficacy profile for the patient. The polymer free platform, which is made of Nitinol, is integrally covered by the Bio Inducer Surface coating, a 2nd generation pure carbon ultra thin layer that drastically increases haemo and bio-compatibility.
Prof. Dierk Scheinert, PI of the Illumina study, stated: “Even though there are stents for the SFA that give good results, there is still a need for improvement especially for the diabetic patient setting where the solutions today available are not providing satisfactory outcomes. Through the Illumina study we will evaluate the innovative NiTiDES device concept and the clinical contribution it will provide for SFA interventions.”
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