Device Dossier

MINI TREK RX Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for MINI TREK RX Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

The MINI TREK RX Coronary Dilatation Catheters are indicated for: ? Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion ? Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction ? Balloon dilatation of a stent after implantation (balloon models 2.00 mm only) ? Balloon dilatation of de novo chronic total coronary occlusions (CTO)

Functional description

The catheters have an integrated shaft that has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen allows facilitation advancement of the dilatation catheter to and through the stenosis to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis. The proximal shaft markers aid in gauging dilatation catheter position relative to the guiding catheter tip.

TGA Public Summary