Device Dossier

Reliant stent graft balloon catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Reliant stent graft balloon catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class…

Intended purpose

The Reliant stent graft balloon catheter is intended to temporarily occlude large vessels to control hemorrhage and to improve endovascular stent graft function by aiding in graft expansion and enhancing graft-to-vessel and graft-to-graft interfaces.

Functional description

The Reliant stent graft balloon catheter has a compliant polyurethane balloon with a maximum diameter of 46 mm. The usable length for this device is 100 cm. This device is designed to accommodate a 0.97 mm (0.038 in) diameter or smaller guidewire. Two radiopaque marker bands are placed within the balloon to facilitate balloon placement, prior to inflation.

TGA Public Summary