Device Dossier

Trek RX Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Trek RX Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class…

Intended purpose

The 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; and balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only).

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