Indications For Use; Contraindications - aptus Heli-FX Instrucciones De Uso

EN
Figure 5 demonstrates the reach provided by the different deflected Guide configurations.
28 mm
22 mm
Heli-FX Guides (16 Fr OD)

2.0 INDICATIONS FOR USE

The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular
aortic grafts and the native artery. The 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.
The EndoAnchor may be implanted at the time of the initial endograft placement, or during
a secondary (i.e., repair) procedure.

3.0 CONTRAINDICATIONS

Treatment with the Heli-FX EndoAnchor System is contraindicated for use in the following
circumstances:
• In patients with a condition that threatens to infect the endograft.
• In patients with a bleeding diathesis.
• In patients with known allergies to the EndoAnchor implant material (MP35N-LT).
• In conjunction with the Endologix Powerlink® endograft.
5
Figure 5: Heli-FX Guides - Available Deflectable Tip Lengths
42 mm
32 mm
22 mm
Heli-FX Guides (18 Fr OD)