Descriptions: Biodegradable Polymer Coating Proven Safety and Efficacy Profile
*This DES uses a biodegradable polymer coating on the stainless steel stent platform. The proprietary, top-quality coating process allows the integrity of coated polymer after excessive stent expansion and a systemic elution of sirolimus in a well -controlled fashion after the stent implantation. The safety and efficacy of the product is well documented from a related randomized trial in Europe in CTO patients showing low re-stenosis rate and very promising late loss data. Specifications: Stent Plaform 316L Stainless Steel
Coating Material PLGA (Biodegradable) Coating Thickness 4.0±1.0μm
Drug Sirolimus (Rapamycine) Drug Content 170μg/cm2±20μg/cm2 (12mm,18mm) 150μg/cm2±20μg/cm2 (23mm,28mm,33mm) Degradation Time >2Months
Clinical Results in 90 Patients with CTO: Control Group Rapa BMS
6 Month MACE 0% 0%
6 Month TVR 11% 55%
6 Month TLR 4% 19%
6 Month In-Stent Restenosis 16% 61%
6 Month In-S
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