Ovation®/Ovation Prime™ Abdominal Stent Graft Systems Instructions for Use
Ovation Prime Instructions for Use can be downloaded by clicking HERE.
Ovation Instructions for Use can be downloaded by clicking HERE.
Indications, Contraindications and Caution Statement
INDICATIONS FOR USE: The TriVascular Ovation/Ovation Prime Abdominal Stent Graft Systems are indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories; proximal aortic landing zone: with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery, and with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm; distal iliac landing zone: with a length of at least 10 mm, and with an inner wall diameter of no less than 8 mm and no greater than 20 mm.
CONTRAINDICATIONS: The TriVascular Ovation/Ovation Prime Abdominal Stent Graft Systems are contraindicated for use in patients who have a condition that threatens to infect the graft and in patients with known sensitivities or allergies to the device materials (including polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, fluorinated ethylene propylene [FEP] or nitinol). Also consider the information in Section 4 Warnings and Precautions of the systems’ Instructions for Use. Refer to Instructions for Use at TriVascular.com for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.