Device Dossier

Pantera LEO - Catheter, angioplasty, balloon dilatation

Device Dossier for Pantera LEO - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III, sponsor Teleflex…

Intended purpose

The Pantera LEO PTCA catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Functional description

The dilatation balloon is designed to inflate to a known diameter/length at recommended inflation pressures. Two radiopaque markers facilitate fluoroscopic visualisation and positioning. The proximal end of the catheter has a single female luer port to inflate/deflate the balloon. The proximal shaft of the catheter is a hypotube which contains shaft exit markers to indicate when the catheter tip exits from the guiding catheter & distal portion of the catheter is a flexible shaft.

TGA Public Summary