Alvimedica @ LINC 2021: “ILLUMINA Study 2 years results: latest updates”

During the eLINC Congress 2021, Pr. Scheinert presented a lecture titled: “ILLUMINA Study 2 years results: latest updates”.
 
The ILLUMINA First In Human study  has been designed to evaluate the efficacy and safety of NiTiDES, the new self-expanding polymer free drug eluting stent for SFA manufactured by CID S.p.A. member of Alvimedica group.
As already disclosed, the 2 years follow up results of the study were impressive: in spite of the complexity of the patients and the lesions (2pts Rutherford 5, lesions up to 140mm and 55% of moderate/ heavy calcifications), the device guarantees excellent SAFETY performance (91.9% Freedom from device related MAE), and great EFFICACY (93.1% Freedom from TLR and 83.4% Primary Patency rate).
In this further release, a new specific sub group analysis dedicated to the diabetic patients has been shown. Thanks to this analysis, it has been demonstrated that, also in this complex settings, the performance of NiTiDES represents a benchmark in the Drug Eluting Stent landscape with a result of 96.8% Freedom from TLR.
 
NiTiDES is a polymer free drug eluting stent with three unique features:

• Amphilimus™ formulation: a combination of Sirolimus and Fatty acid  
• Abluminal Reservoir Technology which allows to control and target the drug elution for 2-3 months
• Bio Inducer Surface coating, a 2^nd generation pure carbon ultrathin layer, which covers integrally the polymer free Nitinol platform and maximizes haemo- and bio-compatibility.

 
In particular referring to the formulation, Prof. Dierk Scheinert, PI of the ILLUMINA study, stated: “The Amphilimus™ formulation has certain advantages shown also in the coronary application in diabetic patients. So we also looked specifically at DM subgroup and, interesting, the freedom from TLR in DM subgroup was even higher than in the overall population, suggesting that diabetic patients can be treated equally well with this device as  non-DM patients.”