Device Dossier

MINI TREK II OTW Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for MINI TREK II OTW Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation,…

Intended purpose

The MINI TREK II OTW Coronary Dilatation 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 • Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction (MI) • 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

These catheters are two-lumen catheters with a balloon near the distal tip. One lumen is used for inflation of the balloon with contrast medium. The second lumen facilitates advancement of the dilatation catheter to and through the stenosis to be dilated, and the injection of contrast and/or medication. The balloon radiopaque marker(s) aid in positioning the balloon in the stenosis. The proximal shaft markers aid in gauging catheter position relative to the guiding catheter tip.

TGA Public Summary