Device Dossier

Atlas® Gold PTA Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Atlas® Gold PTA Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III,…

Intended purpose

The Atlas® Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Functional description

This device is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis.

TGA Public Summary