Device Dossier

Emerge Over-The-Wire PTCA Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Emerge Over-The-Wire PTCA Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation,…

Intended purpose

The Emerge Over-The-Wire(OTW) PTCA Dilation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge OTW PTCA Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

Functional description

Emerge OTW PTCA Catheter is used to enlarge a narrowed coronary artery with an inflatable balloon attached to distal tip of catheter. Whilst balloon is deflated, catheter is inserted into narrowed coronary artery. Inner lumen permits guidewires to assist advancement of catheter to & through stenosis to be dilated. Once positioned inside narrowed artery, outer lumen used to inflate balloon to widen coronary artery blockages. Balloon then deflated & catheter removed.

TGA Public Summary