Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

The primary purpose of this study is to evaluate the safety of this device as there are no or
very limited devices and clinical options available for this patient population. The primary
safety endpoint of this study is safety freedom from major adverse events (MAE) at 30 days or
during hospitalization if this exceeds 30 days. Major adverse events include death, bowel
ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
The primary safety endpoint will be analyzed to determine statistical significance when
compared to a target performance goal. A literature review of outcomes of open surgical
repair was used to create the performance goal as there is not a comparable endovascular
option to use for analysis. The performance goal was selected based on the range of subjects
experiencing a major adverse event at 30 days. The range was calculated based on assumptions
of the minimum and maximum number of subjects experiencing at least one MAE in the historical
open surgical repair group . Based on the literature reviewed and the above assumptions the
range of subjects experiencing at least one MAE in the open surgical repair group is 30.5% to
77.4%.

The primary effectiveness endpoint is the proportion of the study subjects with treatment
success at 1 year. The data will be presented as quality outcomes with the number of study
subjects with treatment success compared to the overall patient population.

Inclusion Criteria:

- A patient may be entered into the study if the patient has at least one of the
following:

- An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just
proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline)
measurements

- Aneurysm with a history of growth > 0.5 cm in 6 months

- Saccular aneurysm deemed at significant risk for rupture

- Symptomatic aneurysm greater than 4.5 cm

- Axillary or brachial and iliac or femoral access vessel morphology that is compatible
with vascular access techniques, devices or accessories, with or without use of a
surgical conduit

- Proximal landing zone for the thoracic bifurcation stent graft that has:

- ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft
material (neck) distal to the left subclavian artery (LSA) diameter in the range
of 26-42 mm

- Adequate distance from the celiac artery, in order to accommodate cannulation
from the antegrade access point when considering the total deployed length of the
thoracic bifurcation and visceral manifold

- Minimum branch vessel diameter greater than 5 mm

- Iliac artery or aortic distal fixation site, including both native tissue and
previously placed graft, greater than or equal to 15 mm in length and diameter in
the range of 8 - 25 mm

- Age: ≥ 18 years old

- Life expectancy: > 1 year

Exclusion Criteria:

- Patient is a good candidate for and elects for open surgical repair

- Can be treated in accordance with the instructions for use with a legally marketed
endovascular prosthesis

- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

- Unwilling to comply with the follow-up schedule

- Inability or refusal to give informed consent by patient or legal representative

- Patient is pregnant or breastfeeding

- Patient has a contained rupture

- Patient has a ruptured aneurysm

- Patient has a dissection in the portion of the aorta intended to be treated

- Obstructive stenting of any or all of the visceral vessels

- Known sensitivities or allergies to the materials of construction of the devices,
including nitinol (Nickel: Titanium) polyester, platinum-iridium,
polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.

- Known hypersensitivity or contraindication to anticoagulation or contrast media that
cannot be adequately medically managed

- Uncorrectable coagulopathy

- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe
capacity of the equipment

- Patient has had a major surgical or interventional procedure unrelated to the
treatment of the aneurysm planned < 30 days of the endovascular repair

- Unstable angina (defined as angina with a progressive increase in symptoms, new onset
at rest or nocturnal angina)

- Systemic or local infection that may increase the risk of endovascular graft infection

- Baseline creatinine greater than 2.0 mg/dL

- History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos
Syndrome)

Anatomical exclusion criteria:

- Thrombus or excessive calcification within the neck of the aneurysm

- Anatomy that would not allow maintenance of at least one patent hypogastric artery

- Anatomy that would not allow primary or assisted patency of the left subclavian artery

These will be determined by standard of care assessments of their disease/aneurysm
morphology by the treating investigator.