Device Dossier

Threader Monorail Micro-Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Threader Monorail Micro-Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (?70% stenosis) for the purpose of improving myocardial perfusion. The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature.

Functional description

Threader Micro-Dilatation Catheter is a rapid exchange catheter with a semi-compliant balloon near the distal tip offered in a 1.2 x 12 mm configuration. The distal section is dual lumen and coaxial. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of guidewires ?0.014 in (0.36 mm) to facilitate advancement of the catheter to the stenosis.

TGA Public Summary