Two-Year ILLUMINA Results Presented for Alvimedica's Nitides Sirolimus-Eluting Stent in SFA

September 8, 2019—Alvimedica announced that 2-year results from the ILLUMINA study were presented during the symposium “Thinking Different for SFA Lesions: the Nitides Solution” at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiology Society of Europe held September 7–11 in Barcelona, Spain.

Alvimedica's Nitides device is a self-expanding, polymer-free nitinol, sirolimus-eluting peripheral stent for treatment of the superficial femoral artery (SFA). The sirolimus combines with fatty acid (amphilimus formulation) through abluminal reservoirs that can control and target the sirolimus elution for 2 to 3 months. The nitinol platform is integrally covered by the Bio Inducer surface coating, a second-generation pure carbon ultrathin layer that maximizes platform hemocompatibility and biocompatibility. Nitides is manufactured by CID S.p.A., a member of the Alvimedica group.

According to Alvimedica, the ILLUMINA first-in-human study is designed to evaluate the efficacy and safety of the Nitides device. The study included 100 patients with complex lesions (lesions up to 140 mm; 55% moderate/heavy calcifications; 2 patients were Rutherford 5).

At 24 months, the study showed 91.9% freedom from device-related major adverse events, confirming the long-term safety performance. Long-term efficacy was confirmed with 93.1% freedom from target lesion revascularization and an 83.4% primary patency rate.

Professor Dierk Scheinert, MD, Principal Investigator of the ILLUMINA study, commented in the company’s announcement, “The ILLUMINA study data at long term are very promising. The low event rates and outcome stability between 1 and 2 years further empower the potential of this innovative device.”