Patient Selection, Treatment And Follow-Up; Implant Procedure; Clinical Use Information - aptus Heli-FX Instrucciones De Uso

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Patient Selection, Treatment and Follow-Up

• Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuousity,
occlusive disease and/or calcification) should be compatible with vascular access techniques
and delivery systems of 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 and/or plaque in the intended
seal zone. Irregular or eccentric calcification and/or plaque may compromise the fixation of
the EndoAnchor 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, and/or
– Sealing zone thrombus, calcium or plaque covering > 50% (180°) of the vessel
circumference.
• The Heli-FX EndoAnchor System is not recommended in patients with known sensitivity or
allergy to contrast agents which are necessary for intra-operative and postoperative follow-up
imaging, or whose renal function may be compromised by the follow-up protocols required for
the endovascular graft.
• Do not use in patients with a known sensitivity or allergy to the EndoAnchor device materials
(nickel, chromium, molybdenum, and cobalt).

Implant Procedure

• Systemic anticoagulation should be used during the implantation procedure based on hospital
and physician preferred protocol. If heparin is contraindicated, an alternative anticoagulant
should be considered.
• Maintain guide wire position during insertion of the Heli-FX Guide with Obturator.
• Always use fluoroscopy for guidance, delivery, and observation of any Heli-FX system
components within the vasculature.
• Do not continue advancing any portion of the Heli-FX System if resistance is felt during
advancement of the guide wire, sheath, or catheter. Stop and assess the cause of resistance.
Vessel, endograft, or catheter damage may occur.
• The use of the Heli-FX EndoAnchor System may require administration of intravascular
contrast. Patients with pre-existing renal insufficiency may have an increased risk of renal
failure postoperatively. Care should be taken to limit the amount of contrast media used
during the procedure.
• Care should be taken during manipulation of catheters, wires and sheaths within an aneurysm
and within a previously-placed endograft. Significant disturbances may dislodge fragments of
thrombus, which can cause distal embolization, or cause displacement of the endograft, which
can lead to endoleaks.
• Incorrect positioning of Heli-FX Guide and Applier may lead to mis-deployment of an EndoAnchor.
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