Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

A descending thoracic aneurysm is a bulge in the aorta. The aorta is a large blood vessel
that carries blood away from your heart to organs in the rest of your body. Your aneurysm is
caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow
larger and may ultimately rupture (break open) or extend in size to seriously affect other
major arteries in the area. In this clinical study the Talent Thoracic Stent Graft will be
placed inside your aorta to block the weakened part of the artery wall from the circulatory
system.

Medtronic Vascular submitted a Pre-Market Application (PMA P070007) to the FDA on February
28, 2007, and received market approval for the Talent Stent Graft System on June 5, 2008. As
a condition of approval, the FDA has requested a post-market trial. In collaboration with the
FDA, Medtronic has designed a post-approval study to document the long-term performance of
the Talent Stent Graft System under post market conditions.

This study will examine the post-market performance of the Talent Thoracic Stent Graft
System. This study is a prospective, non-randomized five-year trial. Originally, a total of
451 subjects were going to be analyzed. That group consisted of 195 enrolled subjects from
the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 planned "de novo"
subjects enrolled after the PMA approval. However, Medtronic discontinued manufacturing of
the study device for US commercialization, and as a result, enrollment was terminated in May
2014, when it was determined that no more proximal devices were available either in inventory
or at the sites. A total of 349 subjects will be analyzed, based on 195 VALOR Test Group
subjects and 154 "de novo" subjects.

Inclusion Criteria: appropriate anatomy for elective repair of the descending thoracic
aortic aneurysm

- iliac/femoral access vessel morphology that is compatible with vascular access
techniques, devices, and or accessories

- non-aneurysmal aortic diameter in the range of 18-42mm; and

- non-aneurysmal aortic proximal and distal neck lengths equal to or greater than 20mm

- subject has a Descending Fusiform Thoracic Aneurysm = to or greater than 5cm in
diameter OR is = to or greater than 2 times the diameter of the non-aneurysmal
thoracic aorta and/or saccular aneurysms/penetrating ulcers

- Signed patient informed consent

Exclusion Criteria:

- Less than 18 yrs old

- pregnant

- unable to comply w/follow-up

- participating in other drug or device trials;

- Subject has a co-morbidity causing expected survival to be less than 1 year