The CUREX Paclitaxel Drug Eluting Rapid Exchange PTCA (Percutaneous Transluminal Coronary Angioplasty) balloon catheter is a drug-releasing balloon system for the treatment of coronary vessels. CUREX is designed to improve the lumen diameter and to reduce restenosis in the treatment of lesions in native coronary arteries.
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 Dose||2.3 µg/mm2|
|Catheter Design||Rapid Exchange delivery system|
|Usable Shaft Length (cm)||140|
|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)