VALOR: The Talent Thoracic Stent Graft System Clinical Study

Inclusion Criteria

• •1. Patient is at least 18 years of age.
• •2. Patient is a surgical or non-surgical candidate
• •3. Patient has a:
• •1. Fusiform focal TAA AND / OR
• •2. Focal saccular TAA or penetrating atherosclerotic ulcer.
• •4. Subject's anatomy must meet all of the following anatomical criteria:
• •1. iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
• •2. non-aneurysmal aortic diameter in the range of 18-42mm; and
• •3. non-aneurysmal aortic proximal and distal neck lengths =/\>20mm
• •5. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to the implant procedure.
• •6. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
• •7. Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.