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

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.