Warnings And Precautions - aptus Heli-FX Instrucciones De Uso

4.0 WARNINGS AND PRECAUTIONS

General
Read all instructions carefully. Failure to properly follow the instructions for use, warnings, and
precautions may lead to serious consequences or injury to the patient.
• The long term performance of the Aptus EndoAnchor has not been established. All patients
should be advised endovascular aneurysm treatment requires long-term, regular follow-up to
assess the patient's health status and endograft performance, and the EndoAnchor does not
reduce this requirement.
• The Heli-FX EndoAnchor System should only be used by physicians trained in vascular
interventional techniques and endovascular aneurysm repair. See Section 8 for physician
training recommendations.
• The Heli-FX System is required for use with the Aptus Fortevo™ AAA Endograft at the time
of endograft implantation. It is optional for use with the Aptus Fortevo Aortic Cuff. Please refer
to the applicable Fortevo IFU.
• The EndoAnchor, Heli-FX EndoAnchor System, and Heli-FX Thoracic EndoAnchor System have
been evaluated via in vitro testing and determined to be compatible with the Cook Zenith®,
Cook Zenith TX2®, Gore Excluder®, Gore TAG®, Jotec E®-vita abdominal, Jotec E®-vita thoracic,
Medtronic AneuRx®, Medtronic Endurant®, Medtronic Talent® AAA, Medtronic Talent® TAA,
and Medtronic Valiant® endografts.
• The manufacturer's IFU provides recommendations regarding the aortic diameter ranges
appropriate for the endograft being used. Because each endograft may be indicated for a unique
range of aortic diameters, not all models of the Heli-FX Guides apply to each endograft.
Refer to Table 3 for Heli-FX Guide compatibility based on the aortic diameter and location
being treated. The appropriate model of Heli-FX Applier will be based on the Guide selected.
• Use with endografts other than those listed above has not been evaluated.
• Bench-top evaluations of the EndoAnchor with the Endologix Powerlink® endograft demonstrated
a propensity for the Powerlink's ePTFE graft material to tear upon loading of the EndoAnchor/
endograft interface. As this could fail to prevent migration or create an endoleak channel at
the site of tearing, the use of the EndoAnchor with the Endologix Powerlink is contraindicated.
• In vitro accelerated durability testing of the EndoAnchor with the Medtronic Talent® AAA
endograft demonstrated the potential for minor graft material hole elongation at the site of
EndoAnchor penetration under severe axial loading (see Section 7). Therefore, the EndoAnchor
should be used with caution in conjunction with Talent endografts, considering the benefits
of EndoAnchor use versus the potential risks for the individual patient. The use of additional
EndoAnchors to further distribute the axial load may be warranted.
• The performance of the Aptus EndoAnchor has not been evaluated for securing multiple endograft
components to one another. Without EndoAnchor securement into aortic tissue, this could
result in graft fabric damage, component separation, and resultant Type III endoleaks.
• The performance of the Aptus EndoAnchor has not been evaluated for securing multiple
anatomical structures together. Such use could result in adverse patient consequences such
as vascular perforation, bleeding, or embolic events.
• The performance of the EndoAnchor has not been evaluated in vessels other than the aorta.
Use of the EndoAnchor to secure endografts to other vessels may result in adverse patient
consequences such as vascular perforation, bleeding, or damage to adjacent structures.
Heli-FX® EndoAnchor® System EN
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