Directions For Use - Medtronic Aptus Heli-FX Gebrauchsanweisung

9. Directions for use

Prior to use of the Heli-FX EndoAnchor system, review this Instructions for Use booklet. The following instructions embody a basic guideline for EndoAnchor implant placement.
Variations in the following procedures may be necessary. These instructions are intended to help guide the physician and cannot substitute for the physician's judgment.
General use information
Standard techniques for placement of arterial access sheaths, guiding catheters, angiographic catheters, and guidewires should be employed during use of the Heli-FX EndoAnchor
system. The Heli-FX Guide with Obturator is compatible with 0.89 mm (0.035 in) diameter guidewires.
Preimplant planning
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Determine accurate anatomy and morphology of the intended aortic sealing zones for placement of the EndoAnchor implants. Table 3 indicates the appropriate Heli-FX
Guide based on the native aortic diameter being treated.
Abdominal aortic sealing zone diameter
Heli-FX Guide tip length model number
Thoracic aortic sealing zone diameter
Heli-FX Guide tip length model number
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 zones. EndoAnchor implants should be implanted only into areas of aortic tissue that is free of calcified plaque or thrombus, or where such pathology is
diffuse and less than 2 mm in thickness. Attempting to place EndoAnchor implants into more severe plaque or thrombus may be associated with implantation difficulty and
suboptimal endograft fixation and/or sealing. Reference Section 4 and Section 7.
•
If placing the EndoAnchor implants at the time of endovascular graft implantation, first implant the endograft per the manufacturer's instructions.
Heli-FX EndoAnchor system procedure preparation
1. Position patient on an imaging table, allowing fluoroscopic visualization from the aortic arch to the femoral artery bifurcations.
2. 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 are compatible with 16 Fr or larger sheaths. The 18 Fr outer diameter Heli-FX EndoAnchor systems are compatible with 18 Fr or larger sheaths.
3. Using fluoroscopic guidance, gain access to the patient's aorta with a 0.89 mm (0.035 in) guidewire through the femoral access site.
4. Perform preimplant angiography to identify the location of the endograft and relevant vascular anatomy (such as great vessels, visceral vessels).
Heli-FX Guide insertion
1. Place an exchange length 0.89 mm (0.035 in) guidewire via the femoral access site into the desired region of the aorta. The Heli-FX Guide may be placed via ipsilateral or
contralateral approach.
2. EndoAnchor implants may be implanted at any time during endograft implantation; however, Medtronic Vascular recommends completing endograft implantation before placing
the EndoAnchor implants. If the physician chooses to implant an EndoAnchor implant with a bifurcated AAA endograft before placing an iliac extension, the endograft's
contralateral gate may be cannulated by standard technique. Confirm proper endograft position before implanting an EndoAnchor implant.
3. Select the appropriate Heli-FX Guide based on the diameter of the aorta being treated and the region in which the endograft is being anchored. See Table 3.
4. Using heparinized saline, flush the Heli-FX Guide via the flush port and flush the obturator via the proximal luer.
5. Insert the obturator into the Guide.
6. Using fluoroscopic guidance, advance the Heli-FX Guide and obturator over the 0.89 mm (0.035 in) guidewire and position it within the desired aortic sealing zone. Use C-shaped
radiopaque marker on the distal tip of the Heli-FX Guide to aid in fluoroscopic visualization. To further aid in visualization, use the linear marker that is located 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.
7. Remove the guidewire and then the obturator to minimize blood loss through the hemostatic seal of the Heli-FX Guide.
Caution: After the obturator is withdrawn, the Heli-FX Guide can be used to manually inject contrast medium to confirm proper endograft position before implanting an
EndoAnchor implant. Before any manual injection, aspirate the Guide using a syringe attached to the one-way valve on the back of the Guide control handle to prevent potential
air ingress into the patient's vasculature. Do not use a power injector to perform angiography through the Heli-FX Guide.
8. Under fluoroscopic guidance, rotate the deflector knob on the control handle clockwise to move the distal tip of the Heli-FX Guide toward the first implant location.
Note: The "C" marker at the distal end of the Guide is formed by a radiopaque material that only extends around a portion of the circumference of the lumen. This marker appears
as a "C" when directed toward the image intensifier, as a solid line when directed laterally relative to the image intensifier, and as a "Ɔ" when directed away from the image
intensifier. The "C" marker provides assistance with properly orienting the Guide relative to the graft and aorta at the appropriate EndoAnchor implant location. A straight
radiopaque marker on the distal end of the Heli-FX Guide is located on the side opposite the direction of deflection. This straight marker provides an indication of the proper
rotational orientation of the Guide prior to deflection. In the lateral view, position the straight radiopaque marker on the opposite side of the intended deployment surface. When
the deflector knob is rotated, the Guide tip will deflect in the opposite direction relative to the straight marker. It is recommended to implant the EndoAnchor implant while viewing
the Guide laterally to the image intensifier (the "C" marker should appear as a solid line parallel to the graft and aortic wall as shown in Figure 6).
10 Instructions for Use English
Table 3. Heli-FX Guide tip configuration and vessel diameter
18 – 28 mm
22 mm tip reach SG-64
18 – 28 mm
22 mm tip reach HG-18-90-22
28 – 32 mm
28 mm tip reach HG-16-62-28
28 – 38 mm
32 mm tip reach HG-18-90-32
38 – 42 mm
42 mm tip reach HG-18-90-42