Alvimedica Announces the CE Mark approval of the new polymer free self expanding Amphilimus eluting DES for SFA lesions, NiTiDES™

Alvimedica announces the CE mark of NiTiDES™, its new polymer free self-expanding Amphilimus™ eluting stent for SFA lesions.

ALVIMEDICA, Istanbul, 31st of May 2021. In the treatment of SFA lesions the option of DES implantation is just related to the first generation of Drug Eluting Stents which releases Paclitaxel, a cytotoxic drug still under scrutiny for its clinical safety. The next generation of such devices is starting today with NiTiDES™, a highly innovative self-expanding DES eluting a Sirolimus based formulation named Amphilimus™ (Sirolimus + Fatty Acid). The Sirolimus drug is very well known for its cytostatic action, which guarantees a high safety profile without compromising efficacy.

NiTiDES™ has been designed to face the clinical challenges when treating patients with SFA lesions. Innovation is the only way to further improve current clinical patient’s outcome and NiTiDES™ has got the latest technologies to date.

NiTiDES™, manufactured by CID S.p.A. member of Alvimedica group, is, in fact, a polymer-free self-expanding stent providing a controlled elution of the Amphilimus™ formulation (Sirolimus + Fatty Acid) through the Abluminal Reservoir Technology which ensures the highest efficacy profile for the patient. The Nitinol body, sealed by the Bio Inducer Surface, provides high haemo- and bio-compatibility increasing the rate of strut coverage and thus potentially reducing thrombogenicity.

The clinical data of the ILLUMINA study at 2 years have shown excellent results: 91.9% Freedom from device related MAE confirms the long-term excellent SAFETY performance. 93.1% Freedom from TLR and 83.4% Primary Patency rate demonstrate also that the high product EFFICACY is maintained over long time. This excellent outcome is also confirmed in complex subgroups such as the one of diabetic patients where the freedom from TLR is 96.8%.

Leyla Alaton, president of Alvimedica, has commented: “As president of Alvimedica I am proud to announce the CE Mark of NiTiDES™, the first and unique Sirolimus eluting stent dedicated to SFA lesions. With the upcoming availability on the market and with the support of the ILLUMINA Clinical results, we can really offer to all the Peripheral Physicians the most advanced technological self-expanding DES with the best TLR ever reported.”

About Alvimedica

Alvimedica is an 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.
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