Medtronic Aptus Heli-FX Gebrauchsanweisung Seite 14

Caution: EndoAnchor implants should not be placed in unsupported endograft sections or sections of grafts where the stents are not fully attached to the graft fabric.
3. Under fluoroscopic guidance, advance the Applier through the Guide until the Applier emerges from the distal end of the Guide and makes contact with the endograft. Slowly,
continue to advance the Applier until resistance is felt, indicating the Applier is firmly pushing the endograft against the vessel wall. Deflection of the Guide away from the
endograft should be visualized under fluoroscopy.
Note: It is recommended to implant EndoAnchor implants in a lateral view as shown in Figure 8. In this orientation the Heli-FX Guide's distal C-marker appears as a solid straight
line. If, upon advancement of the Applier, the distal C-marker of the Guide changes from a straight line to resemble a "C" shape, this indicates that the Applier is no longer
perpendicular to the endograft (see Figure 9). If this occurs, the apposition force should be reduced by slightly retracting the Applier, and the Guide repositioned as necessary.
See Figure 8 for proper implant orientation. Attempting to implant EndoAnchor implants in a tangential orientation may result in implant difficulty and suboptimal endograft fixation
or sealing.
4. Using the control handle of the Heli-FX Applier, firmly press the middle of the Forward control button for the first stage of EndoAnchor implant deployment. The EndoAnchor
implant will partially deploy and pause. Four audible tones should be heard and the forward and reverse arrow lights will alternate, indicating that the operator may continue
deployment or withdraw the EndoAnchor implant back into the Applier.
Note: If the EndoAnchor implant is not in the desired location, firmly press the middle of the reverse control button to rehouse the EndoAnchor implant inside the Applier and
reposition the Applier.
Note: Assess successful EndoAnchor implant penetration by verifying that the tip of the EndoAnchor implant can be seen outside of the stent structure during the pause state.
5. If the EndoAnchor implant is in the desired location, complete the final stage of EndoAnchor implant deployment by firmly pressing the middle of the Forward control button. When
this stage is complete, 3 audible tones are heard and the reverse green arrow flashes.
Warning: Do not attempt to deploy an EndoAnchor implant without first confirming that the position of the Heli-FX Applier is firmly against the endograft and aortic wall.
Deployment of an EndoAnchor implant without proper apposition may result in poor endograft fixation or a dislodged EndoAnchor implant, which may require endovascular or
surgical intervention to retrieve.
Caution: Under fluoroscopy, carefully and slowly retract the Heli-FX Applier away from the endograft wall to ensure that it is released from the deployed EndoAnchor implant.
6. Remove the Applier leaving the Guide in place. Under fluoroscopy, visually confirm the placement of the EndoAnchor implant.
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 implant is partially deployed in a patient, the EndoAnchor implant may be removed by manually
rotating the handle and catheter in a counter-clockwise direction until the EndoAnchor implant disengages from the endograft and tissue. The Applier can then be removed from
the Guide.
7. Flush the Heli-FX Guide and Applier with heparinized saline to prevent clotting in the lumen, as needed.
8. Load the next EndoAnchor implant by repeating the steps as described previously.
12 Instructions for Use English
Table 5. Recommended minimum numbers of EndoAnchor implants – tube endografts
Aortic neck diameter (Proximal or Distal)
≤ 29 mm
30-32 mm
33-36 mm
37-40 mm
> 40 mm
Figure 8. Proper EndoAnchor implant placement
Figure 9. Improper EndoAnchor implant placement.
Graft angulation
≤ 60° > 60°-75°
4 4
4 4
4 5
5 6
5 7
> 75°-90°
4
5
7
8
9