Device Description; Zenith Alpha Thoracic Endovascular Graft; Introduction System; Zenith Alpha Thoracic Endovascular Graft Ancillary Components - COOK Medical ZENITH ALPHA Mode D'emploi

ENGLISH
ZENITH aLPHa™ THoRaCIC ENDoVaSCULaR
GRafT
Read all instructions carefully. failure to properly follow the instructions,
warnings, and precautions may lead to serious consequences or injury to
the patient.
CaUTIoN: federal (U.S.a.) law restricts this device to sale by or on the order
of a physician.
CaUTIoN: all contents of the inner pouch (including the introduction
system and endovascular graft) are supplied sterile, for single use only.

1 DEVICE DESCRIPTION

1.1 Zenith Alpha Thoracic Endovascular Graft

The Zenith Alpha Thoracic Endovascular Graft is a two-piece cylindrical
endovascular graft consisting of proximal and distal components. The
proximal components can be either tapered or non-tapered and may be used
independently or in combination with a distal main body component. The stent
grafts are constructed of woven polyester fabric sewn to self-expanding nitinol
stents with braided polyester and monofilament polypropylene suture (fig. 1).
The Zenith Alpha Thoracic Endovascular Graft is fully stented to provide stability
and the expansile force necessary to open the lumen of the graft during
deployment. Additionally, the nitinol stents provide the necessary attachment
and seal of the graft to the vessel wall.
For alignment and added fixation, the proximal component has an uncovered
stent at the proximal end and an internal sealing stent with fixation barbs that
protrude through the graft material. In addition, the bare stent at the distal end
of the distal component also contains barbs. On devices with diameters of
40-46 mm, the proximal sealing stent remains constrained to assure alignment
to the inner curvature of the aorta. To facilitate fluoroscopic visualization of
the stent graft, gold radiopaque markers are positioned on each end of the
proximal and distal components. These markers are placed in a circumferential
orientation at the most proximal and distal aspects of the graft material.

1.2 Introduction System

The Zenith Alpha Thoracic Endovascular Graft is shipped preloaded onto an
introduction system. It has a sequential deployment method with built-in
features to pro vide continuous control of the endovascular graft throughout the
deployment procedure. The introduction system enables precise positioning
before deployment of the proximal and/or distal components.
The main body graft components are deployed from a 16 French (6.0 mm OD),
18 French (7.1 mm OD) or 20 French (7.7 mm OD) introduction system. The
proximal component's introduction system is slightly pre-curved to assist in
proximal inferior wall apposition of the graft during deployment (fig. 2). These
systems use either a single locking mechanism (proximal component and
distal extension) or dual locking mechanisms (distal component) to secure the
endovascular graft onto the introduction system until released by the physician.
All introduction systems are compatible with a .035 inch wire guide.
The introduction system features a Flexor introducer sheath with a Captor
Hemostatic Valve. For added hemostasis, the Captor Hemostatic Valve can be
loosened or tightened for the introduction and/or removal of ancillary devices
into and out of the sheath. The Flexor introducer sheath resists kinking and is
hydrophilically coated. Both features are intended to enhance trackability in the
iliac arteries and thoracic aorta.
1.3 Zenith Alpha Thoracic Endovascular Graft Ancillary
Components
Ancillary endovascular components (distal extensions) are available. Zenith
Alpha Thoracic Endovascular Graft ancillary components are cylindrical
components constructed from the same woven polyester fabric, self-expanding
nitinol stents, and polyester and polypropylene suture used in constructing
the main body graft components. At the distal and proximal graft margins, the
z-stents are attached to the inner surface for enhanced sealing (fig. 1). Distal
extensions can be used to provide additional length to the endovascular graft
distally or increase the length of overlap between components. Additional
proximal components may be used to extend graft coverage proximally.
The Zenith Alpha Thoracic Endovascular Graft Distal Extension is deployed from
either 16 French (6.0 mm OD), 18 French (7.1 mm OD) or 20 French
(7.7 mm OD) introduction system (fig. 2). A single locking mechanism locks the
endovascular graft onto the introduction system until released by the physician.
The locking mechanism is released by turning the rotation handle. All systems
are compatible with a .035 inch wire guide.
To facilitate fluoroscopic visualization of the distal extension, gold radiopaque
markers are positioned on the ends of the graft in a circumferential orientation
at the most proximal and distal aspects of the graft material.

2 INTENDED USE

The Zenith Alpha Thoracic Endovascular Graft is indicated for the endovascular
treatment of patients with aneurysms/ulcers of the descending thoracic aorta
having vascular morphology suitable for endovascular repair (fig. 3), including:
• Iliac/femoral anatomy that is suitable for access with the required
introduction systems,
• Non-aneurysmal aortic segments (fixation sites) proximal and distal to the
aneurysm or ulcer:
• with a length of at least 20 mm, and
• with a diameter measured outer wall to outer wall of no greater than
42 mm and no less than 15 mm.

3 CONTRAINDICATIONS

The Zenith Alpha Thoracic Endovascular Graft is contraindicated in:
• Patients with known sensitivities or allergies to polyester, polypropylene,
nitinol, or gold.
• Patients with a systemic infection who may be at increased risk of
endovascular graft infection.

4 WARNINGS AND PRECAUTIONS

4.1 General

• Read all instructions carefully. Failure to properly follow the instructions,
warnings, and precautions may lead to serious consequences or injury to the
patient.
• The Zenith Alpha Thoracic Endovascular Graft should only be used by
physicians and teams trained in vascular interventional techniques
(catheter-based and surgical) and in the use of this device. Specific training
expectations are described in Section 9.1, Physician Training.
• Additional endovascular interventions or conversion to standard open
surgical repair following initial endovascular repair should be considered for
patients experiencing enlarging aneurysms or ulcers, unacceptable decrease
in fixation length (vessel and component overlap) and/or endoleak. An
increase in aneurysm or ulcer size and/or persistent endoleak or migration
may lead to aneurysm/ulcer rupture.
• Patients experiencing reduced blood flow through the graft and/or leaks
may be required to undergo secondary endovascular interventions or
surgical procedures.
• Always have a qualified surgery team available during implantation or
reintervention procedures in the event that conversion to open surgical
repair is necessary.
I-ALPHA-TAA-1306-436-01

4.2 Patient Selection, Treatment and Follow-Up

• The Zenith Alpha Thoracic Endovascular Graft is designed to treat aortic
neck diameters no smaller than 15 mm and no larger than 42 mm. The
Zenith Alpha Thoracic Endovascular Graft is designed to treat proximal aortic
necks (distal to either the left subclavian or left common carotid artery) 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.
• 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
necessary to achieve access in some patients.
• Key anatomic elements that may affect successful exclusion of the
aneurysm/ulcer include severe angulation (radius of curvature <20 mm
and localized 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 circumferential thrombus and/or
calcification at the arterial fixation sites. Irregular calcification and/or plaque
may compromise the attachment and sealing at the fixation sites. In the
presence of anatomical limitations, a longer neck length may be required to
obtain adequate sealing and fixation. Necks exhibiting these key anatomic
elements may be more conducive to graft migration.
• The Zenith Alpha Thoracic Endovascular Graft and ancillary components
have not been formally tested in the following patient populations:
• aortobronchial and aortoesophageal fistulas
• aortitis or inflammatory aneurysms
• diagnosed or suspected genetic connective tissue disease (e.g., Marfans or
Ehlers-Danlos Syndrome)
• dissections
• females who are pregnant, breast feeding, or planning to become
pregnant within 60 months
• leaking, pending rupture or ruptured aneurysm
• patients 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 Section 4.3 Pre-Procedure Measurement
Techniques and Imaging.
• 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.
• The Zenith Alpha Thoracic Endovascular Graft is not recommended for
patients who cannot tolerate contrast agents necessary for intraoperative
and postoperative follow-up imaging. All patients should be monitored
closely and checked periodically for change in the condition of their disease
and the integrity of the endoprosthesis.
• The Zenith Alpha Thoracic Endovascular Graft is not recommended for
patients whose weight and/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.

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 Alpha Thoracic Endovascular Graft. 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 the image intensifier (C-arm) so that it
is perpendicular to the aneurysm or ulcer 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 imaging modality to accurately assess proximal and
distal neck lengths for the Zenith Alpha Thoracic Endovascular Graft. These
reconstructions should be performed in sagittal, coronal and varying oblique
views de pending upon individual patient anatomy. If 3-D reconstruction
is not available, the patient should be referred to a facility with these
capabilities.
• The long-term performance of endovascular grafts has not yet been
established. all patients should be advised that endovascular treatment
requires life-long, regular follow-up to assess their health and the
performance of their endovascular graft. Patients with specific clinical
findings (e.g., endoleaks, enlarging aneurysms or ulcers, or changes in the
structure or position of the endovascu lar graft) should receive enhanced
follow-up. Specific follow-up guidelines are described in Section 11,
IMaGING GUIDELINES aND PoSToPERaTIVE foLLoW-UP.
• The Zenith Alpha Thoracic Endovascular Graft is not recom m ended
in patients unable to undergo, or who will not be compliant with, the
necessary preoper ative and postoperative imaging and implantation studies
as described in Section 11, IMaGING GUIDELINES aND PoSToPERaTIVE
foLLoW-UP.
• After endovascular graft placement, patients should be regularly monitored
for endoleak flow, aneurysm or ulcer growth, or changes in the structure
or position of the endovascular graft. At a minimum, annual imaging is
required.
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