Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms

The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular
repair of Abdominal Aortic Aneurysm (AAA). The system was designed with the following
enhancements: a suprarenal wire frame to provide migration resistance, and improved
flexibility designed to treat difficult anatomies.

Medtronic Vascular submitted a Pre-Market Application (PMA) to the Food and Drug
Administration (FDA) on October 17, 2007, and received market approval for the Talent
Abdominal Stent Graft System on April 15th, 2008. As a condition of approval, the FDA has
requested a post-approval study. Medtronic has therefore designed a post-approval study, in
collaboration with FDA, to document the performance of the Talent Abdominal Stent Graft
System under market conditions.

Inclusion Criteria:

- Subject must have an abdominal aortic aneurysm, with or without iliac involvement.

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

- A proximal aortic neck length of ≥ 10mm;

- Proximal aortic neck angulation ≤ 60°;

- Distal iliac artery fixation length of ≥ 15mm;

- An aortic neck diameter of 18-32mm and iliac artery diameters of 8-22mm; and

- Vessel morphology suitable for endovascular repair.

Exclusion Criteria:

- Are less than 18 years of age

- Are pregnant or lactating

- Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac
and/or superior mesenteric artery

- Have aneurysmal involvement or occlusion (surgically performed or naturally occurring)
of the bilateral internal iliac arteries

- Have vessels and/or aneurysm dimensions that cannot accommodate the Talent Abdominal
Stent Graft as per the indications in Section 3.

- Have no distal vascular bed (one vessel lower extremity run-off required)

- Have contraindications for use of contrast medium or anticoagulation drugs

- Have an uncorrectable coagulopathy

- Have an SVS/AAVS score greater than 2

- Have a mycotic aneurysm

- Have circumferential mural thrombus in the proximal aortic neck

- Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular
accident (CVA), or major surgical intervention

- Have traumatic aortic injury

- Have leaking, pending rupture or ruptured aneurysms

- Have pseudoaneurysms resulting from previous graft placement

- Require a revision to previously placed endovascular stent grafts.

- Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes)

- Have concomitant thoracic aortic or thoracoabdominal aneurysms

- Are patients with active systemic infections

- Are patients who have a condition that threatens to infect the graft.

- Are patients with sensitivities or allergies to the device materials.

- Have access vessels (as determined by treating physician) that preclude safe insertion
of the delivery system. NOTE: Iliac conduits may be used to ensure the safe insertion
of the delivery system.