OPN NC - 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

The percutaneous transluminal coronary angioplasty catheter operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. Distally it has a double lumen shaft housing the guide wire lumen and the inflation media lumen. The balloon is designed to uniformly expand to the nominal diameter and length at nominal pressure as labeled.