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The OPN NC PTCA Dilatation Catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable coronary stents.

The OPN NC PTCA Dilatation Catheter is a sterile, single use, rapid exchange catheter with a distal non-compliant double layer balloon attached to a flexible distal polymer shaft. The balloon is made from Polyamide and is available in diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 and 4.5mm and in balloon lengths of 10, 15 and 20mm. The distal polymer shaft consists of a two coaxial lumens, with one lumen for inflation and the other to enable the use of a quide wire for positioning the catheter. The catheter is compatible with a 0.014" guidewire, which enters at the distal tip of the catheter and exists at the RX port. The proximal portion of the catheter is formed from a hypotube containing the inflation lumen. At the proximal end, a hub with luer connector is attached to the hypotube, allowing connection to an inflation device. Radiopaque balloon marker bands enable accurate positioning of the device. Shaft markers for brachial and femoral techniques are also in place. The OPN NC comes in a single useable length of 147cm. The device nominal pressure is 10 atm and the rated burst pressure is 35 atm.