Device Dossier

Sterling Monorail PTA Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Sterling Monorail PTA Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon…

Intended purpose

Indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Functional description

The device is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014in or 0.018in to facilitate advancement of the catheter to and through the stenosis to be dilated.

TGA Public Summary