Device Dossier

Threader Over-The-Wire Micro-Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

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

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. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another. The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature

Functional description

Threader Over-The-Wire Micro-Dilatation Catheter is an over-the–wire catheter with a semi-compliant balloon near the distal tip offered in a 1.2 x 12 mm configuration. The distal and proximal sections of the OTW catheter are 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