End Of Procedure; Imaging Guidelines And Post-Operative Follow-Up - aptus Heli-FX Instrucciones De Uso

• Remove the Applier leaving the Guide in place. Under fluoroscopy, visually confirm the
placement of the EndoAnchor.
CAUTION: Withdraw the Applier slowly from the Guide in order to prevent potential air ingress.
WARNING: In the event of power loss to the Heli-FX Applier when an EndoAnchor is partially
deployed in a patient, the EndoAnchor may be removed by manually rotating the handle and
catheter in a counter-clockwise direction until the EndoAnchor disengages from the endograft and
tissue. The Applier can then be removed from the Guide.
• Flush the Heli-FX Guide and Applier with heparinized saline to prevent clotting in the lumen,
as needed.
• Load the next EndoAnchor by repeating the steps as described above.
• Prior to re-positioning the Heli-FX Guide for deployment of additional anchors, straighten
the tip of the Guide by turning the Deflector Knob counter-clockwise. To re-position the
Guide, rotate the control handle to the next location for EndoAnchor deployment and
deflect the Guide tip by turning the Deflector Knob clockwise. The linear marker can be used
as an aid in rotating the Guide with the tip straightened; the marker is on the outer curve
of the deflectable tip. Repeat the deployment of EndoAnchors as desired, referencing the
recommended minimum numbers of anchors provided in Table 4 and Table 5 above.
CAUTION: To prevent accidental dislodgement or movement of the endograft, always straighten
the Heli-FX Guide before rotation within the endograft.
• After deployment of the last EndoAnchor, remove the Heli-FX Applier. Straighten the Guide
by turning the Deflector Knob counterclockwise. Re-advance the Obturator through the
hemostatic seal of the control handle on the Heli-FX Guide. Then advance a 0.035" guide
wire through the Obturator.
• Remove only the Heli-FX Guide and Obturator, leaving the 0.035" guide wire in position.

End of Procedure

• Perform post-implant aortic angiography to evaluate EndoAnchor implantation.
• Check for endoleaks. If an endoleak is observed, use standard endovascular techniques
to resolve. Additional EndoAnchors may be placed as described above, if necessary.
• Check for proper location, blood flow, and patency of endograft.
• Remove the 0.035" guide wires and femoral access sheath (if used) and close the femoral
arteriotomy according to standard practice.
10.0 IMAGING GUIDELINES AND POST-OPERATIVE
FOLLOW-UP
General
The long term safety and effectiveness of the EndoAnchor has not been established; thus Aptus
does not recommend altering the endograft manufacturer's follow-up schedule solely due
to EndoAnchor use at the initial implant procedure.
The long term effectiveness of secondary endovascular interventions to address failures of
previously-placed aortic endografts also has not been established. Therefore, Aptus recommends
consideration of an enhanced follow-up schedule in patients who have exhibited migration and/or
Type I endoleak, and who have been treated with the EndoAnchor as part of a secondary intervention.
Typically, enhanced follow-up includes a reversion to the original follow-up schedule following initial
endograft implantation. Consult the endograft manufacturer's instructions.
Heli-FX® EndoAnchor® System EN
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