Device Dossier

Gateway PTA Balloon Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Gateway PTA Balloon Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III,…

Intended purpose

The Gateway PTA Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.

Functional description

The Gateway PTA balloon catheter is an over-the-wire co-axial catheter with a balloon near the distal tip. The outer lumen is used for inflation of the balloon & the wire lumen permits the use of guidewires. The catheter is coated with a hydrophilic surface that reduces friction during manipulation. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Marker bands, in conjunction with fluoroscopy, aid in the placement of the catheter balloon.

TGA Public Summary