Device Dossier

Scoreflex NC Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Scoreflex NC Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

Scoreflex NC is indicated for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

Functional description

Scoreflex NC is a scoring balloon catheter designed for easy guidewire exchange. The lumen tip section of the catheter is compatible with a 0.014 inch guidewire. The guide wire enters the catheter tip and advances coaxially out the tip Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. When the balloon inflates it expands the lesion and generates focal forces at the location of the wires external to the balloon.

TGA Public Summary