Device Dossier

Conquest - Catheter, angioplasty, balloon dilatation

Device Dossier for Conquest - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III, sponsor Bard). ARTG…

Intended purpose

Conquest PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Functional description

It is a Percutaneous Transluminal Angioplasty catheter with a coaxial shaft and a balloon available in various sizes. The balloon is an underlying PET balloon with layers of UHMW Polyethylene strands, bonded with a Pebax outer layer. Packaged with every catheter is a profile reducing sheath that is positioned over the balloon for protection before use.

TGA Public Summary