aptus Heli-FX Instrucciones De Uso página 18

EN
CAUTION: EndoAnchor implant locations should be based upon a detailed examination of the
preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing
zone(s). EndoAnchors should be implanted only into areas of aortic tissue free of calcified plaque
or thrombus, or where such pathology is diffuse and less than 2 mm in thickness. Attempting to
place EndoAnchors into more severe plaque or thrombus may be associated with implantation
difficulty and suboptimal endograft fixation and/or sealing. Reference the Warnings and Precautions
and Clinical Data sections above.
• If placing EndoAnchors primarily (i.e., at the time of endovascular graft implantation), implant
the endograft per manufacturer's instructions prior to placement of EndoAnchors.
• For implantation with the Aptus Fortevo AAA Endograft, EndoAnchors must be placed prior
to release of the Main Body endograft from its delivery system. Please refer to the Instructions
for Use for the Fortevo AAA Main Body Endograft.
Heli-FX EndoAnchor System Procedure Preparation
• Position patient on an imaging table, allowing fluoroscopic visualization from the aortic arch
to the femoral artery bifurcations.
• Secure access to a common femoral artery using standard technique with introducer sheath
sizes appropriate for the delivery systems being used. The 16 Fr outer diameter Heli-FX
EndoAnchor Systems is compatible with 16 Fr or larger sheaths. The 18 Fr outer diameter
Heli-FX EndoAnchor Systems is compatible with 18 Fr or larger sheaths.
• Using fluoroscopic guidance, gain access to the patient's aorta with a 0.035" guide wire
through the femoral access site.
• Perform pre-implant angiography to identify the location of the endograft and relevant
vascular anatomy (great vessels, visceral vessels).
Heli-FX Guide Insertion
• Place an exchange length 0.035" guide wire via the femoral access site into the desired region
of the aorta. The Heli-FX Guide may be placed via ipsilateral or contralateral approach.
• EndoAnchoring may be performed at any time during endograft implantation; however, Aptus
recommends completing endograft implantation prior to placement of EndoAnchors. Should
the physician choose to perform EndoAnchoring with a bifurcated AAA endograft prior to
placement of an iliac extension, the endograft's contralateral gate may be cannulated by
standard technique. Proper endograft position should be confirmed prior to EndoAnchoring.
• Select the appropriate Heli-FX Guide model based on the region of the aorta in which the
endograft is being anchored and the diameter of the aorta being treated. See Table 3 above.
• Using heparinized saline, flush the Heli-FX Guide via the flush port and the Obturator via the
proximal luer.
• Insert the Obturator into the Guide.
• Using fluoroscopic guidance, advance the Heli-FX Guide and Obturator over the 0.035" guide
wire and position within the desired aortic sealing zone. Use the radiopaque marker at the
distal end of the Obturator tip and the C-shaped radiopaque marker on the distal tip of the
Heli-FX Guide to aid in fluoroscopic visualization. To further aid in visualization, a linear
marker is placed along the length of the deflectable tip, on the wall opposite the direction
of deflection.
NOTE: Any release control mechanism of the endograft's proximal or distal stent must be released
prior to the Heli-FX Guide placement to ensure proper apposition of the endograft to the aortic neck
sealing zone and to avoid interference between the Heli-FX system and endograft delivery system.
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