HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm

Inclusion Criteria

• Male and female age ≥ 18.
• Presence of at least one of the following:

i. Abdominal aortic aneurysm ≥ 5.0cm in diameter (perpendicular to the line of flow).

ii. Abdominal aortic aneurysm 4.5-5.5cm in diameter which increased in size - ≥ 0.5cm over 6 months or 1.0cm over one year.

iii. Abdominal aortic aneurysm >50% larger than the normal aortic diameter.

• Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
• Femoral artery diameter of ≥6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter.
• Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA.
• To be eligible to receive the Horizon having the following characteristics, as demonstrated on CTA or MRA imaging:

I. Infrarenal aortic diameter of 18-28 mm II. Aortic length (lower renal artery to lowest point of aortic bifurcation) of 115-150 mm III. Iliac artery diameter of 10-19 mm IV. Proximal aortic neck length ≥ 15 mm V. Proximal aortic neck angulation ≤ 60° VI. Diameter measured 20mm above aortic bifurcation floor should be ≥ 20mm VII. Aortic bifurcation angulation of ≥ 70°. 7. Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document.

Exclusion Criteria

• If female and of childbearing potential , patients who are:
• pregnant (as determined by a positive pregnancy test performed between 10 to 5 days before implantation date), or
• intend to become pregnant during the study period, or
• do not accept to use adequate double barrier contraception methods for the entire study duration to avoid pregnancy
• Life expectancy of less than 1 year.
• Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
• Patient is in need for an emergent surgery for a ruptured aneurysm.
• Patient with an increased risk for aneurysm rupture, such as, saccular aneurysm, aneurysm with isolated wall protrusion and penetrating ulcers of the aorta.
• A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
• Presence of thrombus or atheroma in proximal aortic neck covering >50% of the endoluminal surface.
• Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to 5.5 cm in diameter.
• Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.
• Patient has a reversed conical neck defined as a > 4mm distal increase over a 10 mm length.
• Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow.
• Patient whose arterial access site is not anticipated to accommodate the 14 Fr diameter of the Horizon™ Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture).
• Patient underwent major surgery or interventional procedure in the last three months.
• Patient is suffering from unstable angina.
• Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation.
• Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
• Contraindication to undergoing angiography.
• Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester.
• Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
• Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes).
• Patient has a history of bleeding diathesis or coagulopathy.
• Active systemic infection at the time o