The CUREX Paclitaxel Drug Eluting Rapid Exchange PTA (Percutaneous Transluminal Angioplasty) balloon catheter is balloon-tipped, drug-releasing balloon system for the treatment of peripheral vessels. CUREX is designed to improve the lumen diameter and to reduce restenosis in the treatment of lesions in native peripheral arteries.
The balloon section of the distal end of the catheter is coated with formulation of Paclitaxel drug and binding agent. In contact with the body liquid 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 PTA balloon Catheter is intended for treatment of atherosclerotic depositions in peripheral lesions, specifically in patients with either in-stent restenosis or de novo peripheral lesions with a reference vessel diameter ranging from 2.00mm to 12.00mm and lesion lengths up to 200mm and it is also intended for pre and post dilatation during peripheral 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 PTA Dilatation Balloon Catheter|
|Generic Name||Paclitaxel Drug Eluting PTA Dilatation Balloon Catheter|
|Product Name||CUREX Paclitaxel Drug Eluting PTA Dilatation Balloon Catheter|
|Available Balloon lengths (mm)||19, 20, 25, 30, 33, 38, 40, 56, 60, 76, 80, 96, 100, 116, 120, 150 & 200|
|Available Vessel Diameters (mm)||2.00 to 12.00|
|Drug Dose||2.3 µg/mm2|
|Balloon Material||Polyn P®|
|Catheter Design||Rapid Exchange delivery system|
|Usable Shaft Length (cm)||150|
|Sheath Compatibility||5 F to 7F|
|Hydrophilic Coating||On the distal and proximal shaft of balloon delivery system|
|Balloon Inflation Pressure||Nominal Pressure (NP):
8 atm (for: Balloon Diameter 2.00 to 8.00mm)
7 atm (for: Balloon Diameter 8.50 to 12.00mm)
Rated Burst Pressure (RBP):
14 atm (for: Balloon Diameter 4.00 to 6.00mm)
12 atm (for: Balloon Diameter 6.50 to 12.00mm)