Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions

The endovascular method consists of the insertion of catheters (vinyl tubes) into both groin
arteries. These catheters then allow positioning of artificial tubes or stent graft(s) into
the diseased blood vessel without the need for major surgery which involves opening the
chest. The blood vessel problem (thoracic aortic aneurysm/lesion) will be treated using an
artificial bypass tube (stent graft) that will be placed inside the diseased artery. The
stent graft(s) that will be used are made of polyester graft fabric sewn to a self-expanding
nickel-titanium (Nitinol) wire frame and is manufactured by Medtronic AVE, Santa Rosa
California.

Aneurysms/lesions can be located in any position along the length of the aorta. This study
evaluates only aneurysms/lesions that occur in the descending part of the thoracic aorta as
it traverses the chest and enters the abdominal cavity. The risk of thoracic
aneurysms/lesions is that they rupture without warning. The risk of rupture increases as the
aneurysm size increases. Following rupture, almost all patients expire within the first 24
hours. For this reason treatment of thoracic aneurysms/lesions is recommended by conventional
surgical means if the patient is a candidate for an operation. The conventional operation
involves occluding the aorta and replacing the aneurysm with a cloth tube that is sewn to
replace the diseased part of the aorta. The major surgery and occlusion of the aorta that is
part of the conventional surgery is directly related to several complications that have been
reported in the literature. In addition, many patients are too ill for conventional surgery
due to concomitant illnesses.

After the procedure, the patient will be followed at regular intervals (pre-discharge, 1
month, 6 months, 12 months and every year thereafter for life) as part of the evaluation of
the experimental treatment. During this time, the patient will have several tests performed
to evaluate the function of the repair. The tests will include clinical examination, x-rays
of the chest and spiral CT scan. The experimental part is the placement of the TALENT
Stent-Graft System using the catheter (endovascular) methods. The risk of the experimental
catheter bypasses is that the procedure may not be successful. In most cases, this would
require a standard operation to repair the problem. Sometimes there are other risks such as
injury to the vessels. Small pieces of diseased arteries may be dislodged which may require
removal. Bleeding may occur from introduction sites, and rarely, infection may develop. If a
catheter bypass is unsuccessful, there can be added discomfort because the procedure may last
longer.

The benefits of the procedure are that the patient might avoid some of of the pain and
discomfort associated with standard operations. Major surgery is avoided and hospital stay
may be much shorter. Patients may be able to return to usual daily activities sooner. In
addition, patients who are too high risk for conventional surgical treatment can have their
aneurysm treated using the endovascular graft if their anatomy is appropriate

Inclusion Criteria:

Subjects who participate in this study as study patients must fulfill the following
criteria:

- Subject is > 18 years of age.

- Subject is not pregnant or lactating. Females of child-bearing potential must practice
a reliable method of contraception.

- Subject is diagnosed with one of the following conditions of the descending thoracic
aorta. All conditions must be verified by diagnostic imaging [ultrasonography,
computed tomography (CT), magnetic resonance imaging (MRI) or angiography].

- A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type)
with or without a co-existing aortic dissection or penetrating aortic ulcer

- Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence
of an aneurysm; OR

- Penetrating aortic ulcer in the absence of an aneurysm; OR

- Traumatic transection; OR

- Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all
layers of the vessel and is not atherosclerotic in origin).

- Subject's anatomy is suitable for placement of the Medtronic/Talent Stent-Graft, with
a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm
neck of at least 10 mm.

- Subject has a TAA that is dilated to > 5 cm in diameter, > 1.5 times the diameter of
the adjacent native/non-aneurysmal aorta, or is symptomatic.

- Subject has a proximal and distal aortic neck diameter > 18 mm and < 42 mm.

- Subject has an arterial access site, either peripherally or via infrarenal abdominal
aorta that is adequate for introduction of the stent-graft delivery system.

- Subject is competent to give informed consent.

- Subject will be available for the periodic follow-up (surveillance) after the
procedure.

Exclusion Criteria:

- Subjects who would participate as study subjects and who fulfill any of the following
criteria may not participate in this study:

- Subject has TAA with less than 10 mm proximal fixation length.

- Subject has an aneurysm that would require exclusion by the stent-graft of the segment
of the aorta that gives rise to dominant spinal cord/intercostal arteries.

- Subject has a lesion that prevents delivery or expansion of the device.

- Subject has systemic infection, or is suspected of having systemic infection.

- Subject has a known mycotic aneurysm.

- Subject is not available or is not willing to come back for periodic follow-up
(surveillance) after the procedure.