COOK Medical Zenith TX2 Gebrauchsanweisung Seite 6

• Always have a qualified surgery team available during implantation or reintervention procedures in
the event that conversion to open surgical repair is necessary.
• The Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus Introduction System
should only be used by physicians and teams trained in vascular interventional techniques (cathe-
ter-based and surgical) and in the use of this device. Specific training expectations are described in
Section 10.1, Physician Training.
• Additional endovascular interventions or conversion to standard open surgical repair following
initial endovascular repair should be considered for patients experiencing enlarging aneurysms, un-
acceptable decrease in fixation length (vessel and component overlap) and/or endoleak. An increase
in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.
• Patients experiencing reduced blood flow through the graft and/or leaks may be required to un-
dergo secondary endovascular interventions or surgical procedures.
4.2 Patient Selection, Treatment and Follow-Up
• The Zenith TX2 TAA Endovascular Graft with Pro-Form is designed to treat aortic neck diameters no
smaller than 20 mm and no larger than 38 mm. The Zenith TX2 TAA Endovascular Graft with Pro-Form
is designed to treat proximal aortic necks (distal to either the left subclavian or left common carotid ar-
tery) of at least 20 mm in length. Additional proximal aortic neck length may be gained by covering the
left subclavian artery (with or without discretionary transposition) when necessary to optimize device
fixation and maximize aortic neck length. Distal aortic neck length of at least 20 mm proximal to the
celiac axis is required. These sizing measurements are critical to the performance of the endovascular
repair.
• Key anatomic elements that may affect successful exclusion of the aneurysm include a radius of
curvature <35 mm; localized aortic neck angulation >45 degrees; short proximal or distal fixation
sites (<20 mm); an inverted funnel shape at the proximal fixation site or a funnel shape at the distal
fixation site (greater than 10% change in diameter over 20 mm of fixation site length); and circum-
ferential thrombus and/or calcification at the arterial fixation sites. In the presence of anatomical
limitations, a longer neck length may be required to obtain adequate sealing and fixation. Irregular
calcification and/or plaque may compromise the attachment and sealing at the fixation sites. Necks
exhibiting these key anatomic elements may be more conducive to graft migration or endoleak.
• Adequate iliac or femoral access is required to introduce the device into the vasculature. Careful
evaluation of vessel size, anatomy and disease state is required to assure successful sheath intro-
duction and subsequent withdrawal, as vessels that are significantly calcified, occlusive, tortuous or
thrombus-lined may preclude introduction of the endovascular graft and/or may increase the risk of
embolization. A vascular conduit technique may be needed to achieve access in some patients.
• The Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus Introduction System is
not recommended for patients who cannot tolerate contrast agents necessary for intra-operative
and post-operative follow-up imaging. All patients should be monitored closely and checked peri-
odically for a change in the condition of their disease and the integrity of the endoprosthesis.
• The Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus Introduction System is
not recommended for patients whose weight or size would compromise or prevent the necessary
imaging requirements.
• Graft implantation may increase the risk of paraplegia or paraparesis where graft exclusion covers
the origins of dominant spinal cord or intercostal arteries.
• The safety and effectiveness of the Zenith TX2 TAA Endovascular Graft with Pro-Form with the
Z-Trak Plus Introduction System has not been evaluated in the following patient populations:
• aortobronchial and aortoesophageal fistulas
• aortitis or inflammatory aneurysms
• diagnosed or suspected congenital degenerative collagen disease (e.g., Marfan's or Ehlers-
Danlos Syndromes)
• females that are pregnant, breast-feeding, or planning on becoming pregnant within 24
months
• leaking, pending rupture or ruptured aneurysm
• less than 18 years of age
• mycotic aneurysms
• pseudoaneurysms resulting from previous graft placement
• systemic infection (e.g., sepsis)
• traumatic aortic injury
• Successful patient selection requires specific imaging and accurate measurements; please see
4.3 Pre-Procedure Measurement Techniques and Imaging
Section
• If occlusion of the left subclavian artery ostium is required to obtain adequate neck length for fixa-
tion and sealing, transposition or bypass of the left subclavian artery may be warranted.
• All lengths and diameters of the devices necessary to complete the procedure should be available
to the physician, especially when pre-operative case planning measurements (treatment diameters/
lengths) are not certain. This approach allows for greater intra-operative flexibility to achieve opti-
mal procedural outcomes.
4.3 Pre-Procedure Measurement Techniques and Imaging
• Lack of non-contrast CT imaging may result in failure to appreciate iliac or aortic calcification, which
may preclude access or reliable device fixation and seal.
• Pre-procedure imaging reconstruction thicknesses >3 mm may result in suboptimal device sizing, or
in failure to appreciate focal stenoses from CT.
• Clinical experience indicates that contrast-enhanced spiral computed tomographic angiography
(CTA) with 3-D reconstruction is the strongly recommended imaging modality to accurately assess
patient anatomy prior to treatment with the Zenith TX2 TAA Endovascular Graft with Pro-Form. If
contrast-enhanced spiral CTA with 3-D reconstruction is not available, the patient should be referred
to a facility with these capabilities.
• Clinicians recommend positioning of the image intensifier (C-arm) so that it is perpendicular to the
aneurysm neck, typically 45-75 degrees left anterior oblique (LAO) for the arch.
Diameter: A contrast-enhanced spiral CTA is strongly recommended for aortic diameter measurements.
Diameter measurements should be determined from the outer wall to outer wall vessel diameter and
not the lumen diameter. The spiral CTA scan must include the great vessels through the femoral heads
at an axial slice thickness of 3 mm or less.
Length: Clinical experience indicates that 3-D CTA reconstruction is the strongly recommended imag-
ing modality to accurately assess proximal and distal neck lengths for the Zenith TX2 TAA Endovascu-
lar Graft with Pro-Form. These reconstructions should be performed in sagittal, coronal and varying
oblique views depending upon individual patient anatomy. If 3-D reconstruction is not available, the
patient should be referred to a facility with these capabilities.
2 ENGLISH
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I-TX2-PRO-FORM-1002-361-02