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The balloon section of the distal end of the catheter is coated with formulation of Paclitaxel drug and binding agent. When in contact with the body fluid the hydrophilic binding agent swells and open the structure for the pressure induced fast release of paclitaxel drug into the vessel wall.
CUREX Paclitaxel Drug Eluting PTCA balloon Catheter is intended for treatment of atherosclerotic depositions in coronary lesions, specifically in patients with either in-stent restenosis or de novo coronary lesions with a reference vessel diameter ranging from 2.00mm to 4.50mm and lesion lengths up to 40mm and it is also intended for pre and post dilatation during coronary stent implantation for improving luminal diameter.
Paclitaxel drug is a proven anti-proliferative drug that blocks cellular proliferation and migration. The CUREX is a coated with a safe and uniform dose of Paclitaxel for consistent vessel treatment.
Paclitaxel was identified as the primary drug for DEB because:
Specifications of CUREX Paclitaxel Drug Eluting PTCA Dilatation Balloon Catheter |
|
Available Balloon lengths (mm) | 9, 14, 17, 20, 25, 30, 33, 38 & 41 |
Available Vessel Diameters (mm) | 2.00 to 4.50 |
Drug | Paclitaxel |
Drug Dose | 2.3 µg/mm2 |
Balloon Material | Polyamide |
Catheter Design | Rapid Exchange delivery system |
Usable Shaft Length (cm) | 140 |
Guidewire Compatibility | 0.014” |
Guiding Catheter Inner Diameter | 5 Fr (0.056”) (1.4 mm) Compatible |
Catheter Outer Shaft Diameter | 2.70 Fr Proximally, 1.95 Fr Distally |
Hydrophilic Coating | On the distal and proximal shaft of balloon delivery system |
Balloon Inflation Pressure | Nominal Pressure (NP): 8 atm Rated Burst Pressure (RBP): 16 atm (for: Balloon Diameter 2.00 to 4.00mm) 14 atm (for: Balloon Diameter 4.50) |