of AAA patients requiring treatment are not eligible for on-label+ EVAR1-5
+Due to specialized anatomies.
Short neck length
Small access vessel diameter
Excessive neck angulation
Featuring Adaptive Sealing Technology –
only on the ALTO abdominal stent graft system.
*Seal zone for the ALTO stent graft is defined as a location 7mm down for the lowest renal.
^The ENCORE analysis pools data on file from ENCORE Data File: April 12, 2018.
a pooled, retrospective analysis of six trials demonstrated
favorable clinical outcomes over five years.
Freedom from AAA-related mortality
Freedom from
conversion
Freedom from
rupture
Freedom from
reintervention for type IA endoleak
Freedom from
device-related reintervention
Freedom from AAA-related mortality
Freedom from
conversion
Freedom from
rupture
Freedom from
reintervention for type IA endoleak
Freedom from
device-related reintervention
**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.
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These are a portrayal of typical EVAR patients and not real patients.
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:
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.
©2023 Endologix LLC. All rights reserved. MM2631-ALL Rev 01
© 2024 Endologix LLC. All rights reserved.
Endologix® products and associated components are not available in all countries or regions. Please contact your Endologix representative for details regarding product availability. Prior to use, refer to the “Instructions for Use” for complete and specificindications, contraindications, all warnings and precautions. Rx only.