CIRSE congress 2019, Sunday September 8th - ALVIMEDICA releases the ILLUMINA study 2year results during the symposium titled “Thinking different for SFA lesions: The NiTiDES solution”. These data reach the Endovascular community after the “Paclitaxel-gate” which has strongly affected the use of Paclitaxel Eluting devices in SFA. NiTiDES represents the first and only Sirolimus eluting self-expanding peripheral stent soon available.
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. Although the ILLUMINA study included complex patients and complex lesions (2pts Rutherford 5, lesions up to 140mm and 55% of moderate/ heavy calcifications), the study results at 24 months are remarkable: 91.9% Freedom from device related MAE confirms the long-term excellent SAFETY performance, while 93.1% Freedom from TLR and 83.4% Primary Patency rate demonstrate that the high product EFFICACY is maintained over long time.
NiTiDES is a polymer free stent eluting Sirolimus combined to Fatty Acid (Amphilimus™ formulation) through Abluminal Reservoirs which can control and target the Sirolimus elution for 2-3 months. The polymer free Nitinol platform is integrally covered by the Bio Inducer Surface coating, a 2nd generation pure carbon ultrathin layer that maximizes platform haemo- and bio-compatibility.
Prof. Dierk Scheinert, PI of the ILLUMINA study, stated: “The ILLUMINA study data at long term are very promising. The low event rates and outcome stability between one and two years further empower the potential of this innovative device.”
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