Device Dossier
Heli-FX Thoracic Endoanchor System - Anchor, soft-tissue implanted, non-biodegradable
Device Dossier for Heli-FX Thoracic Endoanchor System - Anchor, soft-tissue implanted, non-biodegradable (Anchor, soft-tissue implanted,…
- GMDN category: Anchor, soft-tissue implanted, non-biodegradable
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 Thoracic 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.