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Pre Clinical Data

Pre Clinical Data

YUKON Choice PC has one of the most robust Preclinical data that establishes the hypothesis of its efficacy and safety trial. The clinical data which is published in "Biomaterials"  demonstrates the safety of the combination of the microporous surface with biodegradable polymer for releasing Sirolimus. It also proves a slow drug release over 4 weeks with adequate  drug concentrations at vascular and peri-vascular tissues.

Aim of this study was the pre-clinical assessment of two novel rapamycin-eluting stent (RES) coating technologies that abstain from use of a durable polymer. YUKON Choice PC(also reffered as R Poly Stent) was evaluated in vitro and in the porcine coronary artery stent model. YUKON Choice PC elutes rapamycin from a biodegradable polymer that is top coated with the resin shellac to minimize the amount of polymer. HPLC based determination of pharmacokinetics indicated drug release for more than 28 days. At 30 days, neointimal formation was found to be significantly decreased for both DESs compared to bare-metal stents. Assessment of vascular healing revealed absence of increased inflammation in both DESs, which is commonly observed in DES with non-erodible polymeric coating. In conclusion, the pre-clinical assessment of RESs with resin-based or dual drug coating indicated an adequate efficacy profile as well as a beneficial effect for vascular healing processes. These results encourage the transfer of technology to clinical evaluation.



Biomaterials - Dr. Kristin Steigerwald

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