Device Dossier
NC TREK RX Dilatation Catheter - Catheter, angioplasty, balloon dilatation
Device Dossier for NC TREK RX Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III,…
- GMDN category: Catheter, angioplasty, balloon dilatation
Intended purpose
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction
Functional description
The catheter has an integrated shaft that has a combination single lumen and dual lumen tubing. One lumen is used for the 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 radiopaque marker(s) aid in positioning the balloon in the stenosis. The proximal shaft markers aid in gauging dilatation catheter position relative to the guiding catheter tip.