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May 31, 2021
Alvimedica’s NiTides Amphilimus-Eluting Stent Receives CE Mark Approval
May 31, 2021—Alvimedica announced CE Mark approval of the company’s NiTides self-expanding, drug-eluting stent for the treatment of peripheral artery disease lesions in the superficial femoral arteries. The polymer-free device elutes Amphilimus, a formulation of sirolimus plus fatty acid, through its abluminal reservoir technology. The NiTides device is manufactured by CID S.p.A. member of Alvimedica group.
According to the company, the device’s nitinol body, sealed by the bio-inducer surface, provides high hemo- and biocompatibility increasing the rate of strut coverage, thus potentially reducing thrombogenicity.
The clinical data of the ILLUMINA study at 2 years, first presented in 2019, showed 91.9% freedom from device-related major adverse events and confirmed the long-term safety performance. Long-term efficacy was demonstrated with a 93.1% rate of freedom from target lesion revascularization (TLR) and an 83.4% primary patency rate. This outcome is confirmed in complex subgroups, such as diabetic patients with a 96.8% freedom from TLR, stated Alvimedica.
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