ITRIXII Sirolimus-Eluting Coronary Stent Implantation System
The ITRIXII Sirolimus-Eluting Coronary Stent Implantation System is the first carbonized stent (Inert Carbon Technology) with a completely biodegradable polymer coating which contains Sirolimus (Rapasorb™) as a highly effective drug for preventing thrombotic and re-stenotic events.
Benefits
> No stent thrombosis during the entire 2-year follow-up period
> Polymer: Poly (D, L-Lactide-co-Glycolid) Polylactide 50% Polyglycolid 50%
> Drug: Sirolimus
> Coating Degradation: 6 weeks in-vivo
> Drug load: 2.0μg/mm2
> 250 Patients with over two years follow-up
The Coating
The biodegradable Polymer contains Poly-lactic-co-glycolic acid (PLGA) which will degrade 100% into carbon dioxide and water.
Sirolimus-Eluting Coronary Stent Implantation System does not need any other auxiliary polymer like parylene C.
The controlled polymer degradation and release of Sirolimus is designed to terminate simultaneously and is completed within less than three months. This covers exactly the time where the drug is needed at most and is tailored uniquely to various immune response reactions occurring after stent implantation. This is understood as Rapasorb™ - Technology.
Figure 1: Inert Carbon Technology
Under vacuum conditions carbon ions are shot with high load of energy on the stent surface, so that the ions are implanted within the metal lattice under the alloy’s surface.
Figure 2: Matrix-Sirolimus Long Term Release
Release Kinetics of Sirolimus-Eluting Coronary Stent Implantation System (Long term release per square mm stent surface) Subject: Drug concentration - Value: 2.0 μg/mm2
Technical Specifications
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