Device Dossier

Heli-FX Endoanchor System - Anchor, soft-tissue implanted, non-biodegradable

Device Dossier for Heli-FX Endoanchor System - Anchor, soft-tissue implanted, non-biodegradable (Anchor, soft-tissue implanted, non-biodegradable, Class…

Intended purpose

The intended use of the Heli-FX EndoAnchor system is to provide augmented radial fixation and sealing between the endovascular aortic stent graft and the native artery.

Functional description

The Heli-FX EndoAnchor system comprise of EndoAnchor that is introduced using the Heli-FX applier and delivered via a steerable guide sheath, the Heli-FX guide. EndoAnchor implants are loaded into the applier from the EndoAnchor cassette by placing the distal end of the applier into an unused EndoAnchor implant port that each holds one EndoAnchor implant. The EndoAnchor implant is designed to attach an endograft to the vessel wall.

TGA Public Summary