These are a portrayal of typical EVAR patients and not real patients.
†Due to specialized anatomies.
*The Ovation platform product family includes a series of device iterations using adaptive neck sealing technology such as Ovation, Ovation Prime, Ovation iX, and ALTO. The devices included in the studies used in the ENCORE analysis all include adaptive sealing technology. ALTO was not included in the ENCORE data set.
ENCORE includes results from real-world patient population. 3% of patients had neck characteristics beyond the FDA-approved anatomic IFU. Safety and effectiveness of Ovation and ALTO when used outside the IFU have not been established. The ENCORE analysis pools data on file from March 20, 2019.
Barleben A, et al. Long-term outcomes of the Ovation Stent Graft System investigational device exemption trial for endovascular abdominal aortic aneurysm repair. J Vasc Surg. 2020;72(5):1667-1673.
Elkouri S, et al. Most patients with abdominal aortic aneurysm are not suitable for endovascular repair using currently approved bifurcated stent-grafts. Vasc Endovascular Surg. 2004;38:401-12.
Arko FR, et al. How many patients with infrarenal aneurysms are candidates for endovascular repair? The Northern California experience. J Endovasc Ther. 2004;11:33-40.
AbuRahma AF, et al. Aortic neck anatomic features and predictors of outcomes in endovascular repair of abdominal aortic aneurysms following vs not following instructions for use. J Am Coll Surg. 2016;222:579-89.
Schanzer A, et al. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation. 2011;123:2848-55.
INDICATIONS FOR USE: The ALTO® Abdominal Stent Graft System is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device, which includes the following:
Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories,
A proximal aortic landing zone for the sealing ring 7 mm below the inferior renal artery.
An aortic sealing zone comprised of healthy aorta defined as:
Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7mm below the inferior renal artery,
Lack of significant calcification at the level of 7 mm below the inferior renal artery,
Conicity < 10% as measured from the inferior renal artery to the aorta 7 mm below the inferior renal artery,
An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery, and
An aortic angle of ≤ 60 degrees
A 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 25 mm.
CONTRAINDICATIONS: The 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, contrast agents, fluorinated ethylene propylene [FEP], titanium, nickel, platinum, or iridium.
Refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
NOTE: Not all product components are available in every country. Please consult with your Endologix representative to confirm product availability.
Endologix is a registered trademark of Endologix LLC in the United States, Europe and Japan and ALTO is a registered trademark of Endologix LLC and its subsidiaries. All other trademarks are the property of their respective owners.