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.
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Specifications: |
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Stent Plaform |
316L Stainless Steel |
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Coating Material |
PLGA (Biodegradable) |
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Coating Thickness |
4.0±1.0μm |
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Drug |
Sirolimus (Rapamycine) |
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Drug Content |
170μg/cm2±20μg/cm2 (12mm,18mm) |
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150μg/cm2±20μg/cm2 (23mm,28mm,33mm) |
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Degradation Time |
>2Months |
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Clinical Results in 90 Patients with CTO: |
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Control Group |
Rapa |
BMS |
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6 Month MACE |
0% |
0% |
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6 Month TVR |
11% |
55% |
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6 Month TLR |
4% |
19% |
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6 Month In-Stent Restenosis |
16% |
61% |
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6 Month In-Stent Late loss |
0.41mm |
1.46mm |
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Length |
9 |
12 |
16 |
18 |
20 |
23 |
28 |
33 |
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Diameter |
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2.50 |
√ |
√ |
√ |
√ |
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√ |
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2.75 |
√ |
√ |
√ |
√ |
√ |
√ |
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3.00 |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
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3.50 |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
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4.00 |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
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