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CUREX PTA Dilatation Balloon Catheter

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.

CUREX- A Novel Concept…

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.

Intended Use

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: A Proven anti-proliferative drug

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.

Why Paclitaxel for DEB??

Paclitaxel was identified as the primary drug for DEB because:

Highly lipophilic hence binds tissue at the target site and resists wash-out
Antiproliferative drug.
Safe and Reliable quantitative Drug deposition into the vessel wall

Unique Design Features of CUREX

It is Effective
Lower restenosis rates than standard PTCA/PTA treatments
Fast recovery of endothelial function
Potential decrease in anti-platelet therapy
Potential for homogenous drug delivery to the vessel wall, unlike DES
Minimal Drug loss during inflation
Safe and Reliable quantitative Drug deposition into the vessel wall
Homogenous drug distribution

Technical Specification of CUREX PTA

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	Paclitaxel
Drug Dose	2.3 µg/mm2
Balloon Material	Polyn P®
Catheter Design	Rapid Exchange delivery system
Usable Shaft Length (cm)	150
Guidewire Compatibility	0.014”
Shaft Diameter	5F
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)