Device Dossier

NIC Nano hydro - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for NIC Nano hydro - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation, coronary, basic,…

Intended purpose

The PTCA 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 PTCA Dilatation Catheter is indicated for: - Dilatation of coronary artery stenosis - Dilatation of bypass graft stenosis - Post dilatation of balloon expandable coronary stents.

Functional description

A balloon is inserted into the vascular system, advanced through a guiding catheter over a guidewire to a stenotic coronary artery or coronary artery bypass graft and is inflated by means of an inflation device and contrast media under angiographic control, thus dilating the luminal diameter of the vessel. The catheter contains two lumina: the inner lumen for the guidewire, the outer lumen extends along the length of the catheter and is used for balloon inflation with contrast media

TGA Public Summary