Delivery Assist And Selective Catheters
Alto™ Abdominal Stent Graft System
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 7mm below the inferior renal artery. • An aortic sealing zone comprised of healthy aorta defined as: o 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, o Lack of significant calcification at the level of 7mm below the inferior renal artery, o Conicity < 10% as measured from the inferior renal artery to the aorta 7mm below the inferior renal artery, o 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 o An aortic angle of ≤ 60 degrees. • A distal iliac landing zone: o With a length of at least 10 mm, and o With an inner wall diameter of no less than 8 mm and no greater than 25 mm.
Key Specifications
- Endovascular device for treating infrarenal abdominal aortic aneurysms (AAAs)
- Delivered via low-profile catheter
- Modular configuration: aortic body, iliac limbs, and iliac extensions
- Includes aortic body stent graft and delivery catheter
- Includes Ovation iX™ iliac limb stent grafts and delivery catheters
- Includes Ovation iX™ iliac extension stent grafts and delivery catheters (as required)
- Includes CustomSeal™ polymer fill kit
- Includes Autoinjector 2
- Primary modifications: sealing ring located 7mm below renal arteries, integrated balloon, lower pressure Autoinjector 2
- Aortic body: proximal suprarenal fixation stent made of Nitinol alloy with 8 anchors
- Aortic body graft: low-permeability polytetrafluoroethylene (PTFE)
- Polymer injector port: PTFE
- Discrete attachments: Nitinol alloy with fluorinated ethylene propylene (FEP)
- Radiopaque markers (attachment coils): Nitinol alloy
- Fill polymer: radiopaque, liquid that solidifies into hydrogel, fills inflatable channels and rings
- Aortic body proximal seal ring sizes: 20, 23, 26, 29, 34 mm
- Aortic body trunk length: 40 mm
- Aortic body leg lengths: 35 mm ipsilateral, 40 mm contralateral
- Aortic body distal inner diameters: 11 mm
- Iliac limbs and extensions: Nitinol stent encapsulated in low-permeability PTFE
- Iliac limb attachments: Nitinol alloy
- Iliac limb radiopaque markers: Platinum-Iridium alloy
- Iliac limbs distal diameters: 10, 12, 14, 16, 18, 22, 28 mm
- Iliac limbs lengths: 80, 100, 120, 140, 160 mm
- Iliac limbs proximal diameter: 14 mm
- Iliac extensions length: 45 mm
- Iliac extensions diameters: same as iliac limbs (10-28 mm)
- Aortic body delivery catheter: working length 60 cm, outer sheath 15 Fr (inner 13 Fr), hydrophilic coated
- Iliac delivery catheters: working length 60 cm, outer diameters 12/10 Fr to 15/13 Fr based on limb size, hydrophilic coated
- Compatible with 0.035” (0.89 mm) guidewire
- CustomSeal™ kit: two fill syringes with polymer components (buffered solution with contrast agent, reactive monomers), 14-minute cure time
- Autoinjector 2: applies controlled force for polymer injection
- Polymer radiopacity dissipates over 1-2 months
- MR Conditional: safe in 1.5T and 3.0T systems under specified conditions
- Sterile via ethylene oxide (stent grafts/delivery systems) or E-beam (kit and autoinjector)
Description
The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.