of AAA patients requiring treatment are not eligible for on-label+ EVAR1-5
+Due to specialized anatomies.
Off-label EVAR is mostly due to:
Short neck length
Small access vessel diameter
Excessive neck angulation
ALTO offers a personalized experience to
meet the individual needs of each patient’s anatomy.
ALTO’s exclusive technology is optimized for specialized anatomies, including tortuous iliacs and short necks:
7mm neck indication
13F ID delivery system
Highly comformable limbs
You need an EVAR solution
as unique as they are
Featuring Adaptive Sealing Technology – only on the ALTO abdominal stent graft system.
ALTO's exclusive adaptive sealing technology
creates an effective seal around the vessel wall,
conforming to the patient’s anatomy. This technology eliminates chronic radial force in the seal zone* and results in stable neck diameters out to 5 years1,2
Adaptive with sealing ring conforming to irregular surface, creating a patient specific seal.
Separation of fixation and seal allows you to fixate in healthy tissue and seal closest to renals.
Treat infrarenal neck lengths as short as 7mm and <60° juxtarenal angulation without adjunctive devices.
ALTO’s integrated balloon enables time-saving interoperative deployment and optimizes the molding of the sealing ring.
PTFE iliac limbs with helical nitinol architecture provide flexibility and minimal luminal encroachment.
97.2% Freedom from secondary intervention due to graft occlusion at 5 years.^
Made to Conform
Built to Perform
*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.
Where versatility and durability meet
The ENCORE** analysis
a pooled, retrospective analysis of six trials demonstrated favorable clinical outcomes over five years.
99%
Freedom from AAA-related mortality
99%
Freedom from conversion
99%
Freedom from rupture
98%
Freedom from reintervention for type IA endoleak
90%
Freedom from device-related reintervention
0%
Freedom from AAA-related mortality
0%
Freedom from conversion
0%
Freedom from rupture
0%
Freedom from reintervention for type IA endoleak
0%
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.
Click Image To Zoom-In
Anatomically adaptive, uniquely powerful
ALTO Testimonial Case Examples
highlight the clinical utility including patient demographics, pre-case planning, intra and post-op results.
Play Video
Dr. Nicolas Mouawad from McLaren Health System
Mouawad - Short Aortic Neck Case
Play Video
Dr. Luis Gomez from St. Joseph
Regional Medical Center
Gomez - Severe Infrarenal Neck Angulation Case
Experience ALTO today: Sign up for VR training demo.
For information on Endologix’s privacy practices, see our Privacy Statement
These are a portrayal of typical EVAR patients and not real patients.
REFERENCES
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.
Legal Information:
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.