he 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.
Description - Sirolimus-Eluting Coronary Stent Implantation System Stainless Steel Bioactive Carbonized Stent Platform
Balloon Characteristic - Semi-Compliant Rapid Exchange Catheter
Recommended Guidewire - 0.014” (0.36 mm)
Recommended Guiding Catheter - 5 F
EntryTip Profile - min 0.45 mm (0.018”)
Nominal Pressure - 0 2.00 mm to 0 4.00 mm: 9 bar
Rated Burst Pressure (RBP) - • - 0 2.00 mm to 0 3.50 mm: 18 bar • - 0 4.00 mm: 16 bar
X-ray Balloon Marker - 2 markers located on the inner distal shaft under balloon section