Aptus Heli-FX EndoAnchor System - Anchor, soft-tissue implanted, non-biodegradable

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

Class III

Manufactured by:

Medtronic Vascular Inc 271 Gibraltar Drive, Sunnyvale, CA, 94089 United States Of America

Therapeutic area:

45612 - Anchor, soft-tissue implanted, non-biodegradable

Therapeutic indications:

The Aptus Heli-FX EndoAnchor System is comprised of an endovascular suture (the EndoAnchor) and implantation means (the Heli-FX Applier) as well as a steerable guide sheath (the Heli-FX Guide) for access and delivery within the vasculature. The Aptus Heli-FX EndoAnchor System (to be deployed in the abdominal aorta)is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Aptus Heli-FX EndoAnchor System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

Authorization status:

A

Authorization date:

2016-12-21