Evaluation of Mechanical Stapler for Aortic Anastomoses

Evaluation of Mechanical Stapler for Aortic Anastomoses

Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients

Inclusion Criteria:

• Patient age is between 21 to 85 years old.
• Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome.
• Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm.
• Patient is scheduled for AAA repair

Exclusion Criteria:

• Pregnant women
• Active malignancy
• Ruptured aneurysm
• Thoraco-AAA
• Patient with at least one of the following unstable risk factors:
• Renal disease (Cr >2)
• Ischemic heart disease (unstable Angina)
• Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam)
• Severe CHF (EF < 25%)
• Patient with known allergy to metals or to the contrast media
• Participation in current or recent (within 60 days prior to surgery) clinical trial