Device Dossier

NC Emerge Monorail PTCA Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for NC Emerge Monorail PTCA Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

The NC Emerge MR PTCA Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC Emerge MR PTCA Dilatation Catheter (balloon models 2.00-5.00 mm) is also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

Functional description

The NC Emerge MR PTCA Dilatation Catheter, is a rapid exchange catheter with a low compliance balloon near the distal tip.The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of guidewires ?0.014 in (0.36 mm) to facilitate advancement of the catheter to and through the stenosis or stent to be dilated.The proximal section of the MR catheter is a single-lumen, hypotube with a single luer port hub for inflation/deflation of the balloon.

TGA Public Summary