Indications For Use; Contraindications; Warnings And Precautions - Medtronic Aptus Heli-FX Gebrauchsanweisung

The Heli-FX Guide is available in 5 configurations of outer diameter, length, and deflectable tip length (or "reach"). The 16 Fr outer diameter Guides have a working length of 62 cm
and deflectable tip lengths of 22 mm or 28 mm. The 18 Fr outer diameter Guides have a working length of 90 cm and deflectable tip lengths of 22 mm, 32 mm, or 42 mm.
Figure 5 demonstrates the reach provided by the different deflected Guide configurations.
1. 28 mm
2. 22 mm
3. 42 mm
4. 32 mm

2. Indications for use

The Aptus Heli-FX EndoAnchor system 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.
The EndoAnchor implant may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

3. Contraindications

Treatment with the Heli-FX EndoAnchor system is contraindicated for use in the following circumstances:
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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

4. Warnings and precautions

4.1. General
Read all instructions carefully. Failure to properly follow the instructions, contraindications, warnings, and precautions may lead to serious surgical consequences or injury to the
patient.
•
Do not use if package is opened.
•
The long-term performance of the Aptus EndoAnchor implant has not been established. All patients should be advised that endovascular aneurysm treatment requires
long-term, regular follow-up visits to assess the patient's health status and endograft performance. The EndoAnchor implant 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 EndoAnchor implant, 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 endograft manufacturer's instructions for use provides recommendations regarding the aortic diameter ranges appropriate for the endograft 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 implant with the Endologix Powerlink™ endograft demonstrated a propensity for the Powerlink ePTFE graft material to tear upon
loading of the EndoAnchor/endograft interface. The use of the EndoAnchor implant with the Endologix Powerlink is contraindicated as a tear in the graft material could lead to
endograft migration or an endoleak channel at the site of the tear.
•
In vitro accelerated durability testing of the EndoAnchor implant with the Medtronic Talent™ AAA endograft demonstrated the potential for minor graft material hole elongation
at the site of EndoAnchor implant penetration under severe axial loading (see Section 7). Therefore, the EndoAnchor implant should be used with caution in conjunction with
Medtronic Talent™ AAA endografts, considering the benefits of EndoAnchor implant use versus the potential risks for the individual patient. Consider the use of additional
EndoAnchor implants to further distribute the axial load.
•
The performance of the Aptus EndoAnchor implant has not been evaluated for securing multiple endograft components together. Not securing EndoAnchor implants into
aortic tissue could result in graft fabric damage, component separation, and resultant Type III endoleaks.
•
The performance of the Aptus EndoAnchor implant 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 implant has not been evaluated in vessels other than the aorta. Use of the EndoAnchor implant to secure endografts to other vessels
may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures.
4.2. Patient selection, treatment, and follow-up
•
Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuousity, occlusive disease, or calcification) should be compatible with vascular
access techniques and delivery systems with the profile of a 16 Fr or 18 Fr vascular introducer sheath. Vessels that are significantly calcified, stenotic, tortuous, or thrombus-
lined may preclude placement of the Heli-FX EndoAnchor system.
•
Key anatomic limitations in the intended aortic sealing zones that may prevent successful use of the Heli-FX system include significant thrombus, calcification, or plaque in
the intended seal zone. Irregular or eccentric calcification, or plaque may compromise the fixation of the EndoAnchor implant in the aortic tissue and inhibit proper fixation and
sealing of the endograft. Patients exhibiting one or more of the features listed below were excluded from the reported clinical study (see Section 7):
Sealing zone thrombus, calcium, or plaque > 2 mm in thickness, or
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1
2
6
Figure 5. Heli-FX guides - available deflectable tip lengths
3
4
5
7
5. 22 mm
6. 16 Fr OD
7. 18 Fr OD
Instructions for Use English 7