OVATION™ ABDOMINAL STENT GRAFT SYSTEM INSTRUCTIONS FOR USE
Ovation Instructions for Use can be downloaded by clicking HERE.
Indications, Contraindications and Caution Statement
INDICATIONS FOR USE: The TriVascular Ovation Abdominal Stent Graft System is indicated for treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair, including: Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories,Non-aneurysmal proximal aortic neck: with a length of at least 7 mm proximal to the aneurysm, with an inner wall diameter of no less than 16 mm and no greater than 30 mm and with an aortic angle of ≤ 60 degrees if proximalneck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm, Adequate 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 Abdominal Stent Graft System is 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 system’s 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.
Ovation Prime Abdominal Stent Graft System INSTRUCTIONS FOR USE
Ovation Prime Instructions for Use can be downloaded by clicking HERE.
Indications, Contraindications and Caution Statement
INDICATIONS FOR USE: The TriVascular Ovation Prime Abdominal Stent Graft System is 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, devices, and/or accessories,Non-aneurysmal proximal aortic neck: with a length of at least 7 mm proximal to the aneurysm, with an inner wall diameter of no less than 16 mm and no greater than 30 mm and with an aortic angle of ≤ 60 degrees if proximalneck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm, Adequate 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 Prime Abdominal Stent Graft System is 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 system’s 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.
