Aortic stent grafts
AFX Endovascular AAA System
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
AFX Endovascular AAA System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| A22-22/C55 | β | MR Conditional | Available |
| A22-22/C55-O20 | β | MR Conditional | Available |
| A22-22/C75 | β | MR Conditional | Available |
| A22-22/C75-O20 | β | MR Conditional | Available |
| A22-22/C95 | β | MR Conditional | Available |
| A22-22/C95-O20 | β | MR Conditional | Available |
| A25-25/C55 | β | MR Conditional | Available |
| A25-25/C55-O20 | β | MR Conditional | Available |
| A25-25/C75 | β | MR Conditional | Available |
| A25-25/C75-O20 | β | MR Conditional | Available |
| A25-25/C95 | β | MR Conditional | Available |
| A25-25/C95-O20 | β | MR Conditional | Available |
| A28-28/C55 | β | MR Conditional | Available |
| A28-28/C55-O20 | β | MR Conditional | Available |
| A28-28/C75 | β | MR Conditional | Available |
| A28-28/C75-O20 | β | MR Conditional | Available |
| A28-28/C95 | β | MR Conditional | Available |
| A28-28/C95-O20 | β | MR Conditional | Available |
| A31-31/C80 | β | MR Conditional | Available |
| A31-31/C80-O20 | β | MR Conditional | Available |
| A31-31/C100 | β | MR Conditional | Available |
| A31-31/C100-O20 | β | MR Conditional | Available |
| A34-34/C80 | β | MR Conditional | Available |
| A34-34/C80-O20 | β | MR Conditional | Available |
| A34-34/C100 | β | MR Conditional | Available |
| A34-34/C100-O20 | β | MR Conditional | Available |
| BA22-40/I13-40 | β | MR Conditional | Available |
| BA22-40/I16-40 | β | MR Conditional | Available |
| BA22-40/I20-40 | β | MR Conditional | Available |
| BA22-50/I16-30 | β | MR Conditional | Available |
| BA22-50/I20-30 | β | MR Conditional | Available |
| BA22-60/I13-40 | β | MR Conditional | Available |
| BA22-60/I16-40 | β | MR Conditional | Available |
| BA22-60/I20-40 | β | MR Conditional | Available |
| BA22-70/I16-30 | β | MR Conditional | Available |
| BA22-70/I20-30 | β | MR Conditional | Available |
| BA22-80/I13-40 | β | MR Conditional | Available |
| BA22-80/I16-40 | β | MR Conditional | Available |
| BA22-80/I16-55 | β | MR Conditional | Available |
| BA22-80/I20-40 | β | MR Conditional | Available |
| BA22-80/I20-55 | β | MR Conditional | Available |
| BA22-90/I16-30 | β | MR Conditional | Available |
| BA22-90/I20-30 | β | MR Conditional | Available |
| BA22-100/I13-40 | β | MR Conditional | Available |
| BA22-100/I16-40 | β | MR Conditional | Available |
| BA22-100/I16-55 | β | MR Conditional | Available |
| BA22-100/I20-40 | β | MR Conditional | Available |
| BA22-100/I20-55 | β | MR Conditional | Available |
| BA22-110/I16-30 | β | MR Conditional | Available |
| BA22-110/I20-30 | β | MR Conditional | Available |
| BA22-120/I13-40 | β | MR Conditional | Available |
| BA22-120/I16-40 | β | MR Conditional | Available |
| BA22-120/I20-40 | β | MR Conditional | Available |
| BA25-40/I13-40 | β | MR Conditional | Available |
| BA25-40/I16-40 | β | MR Conditional | Available |
| BA25-40/I20-40 | β | MR Conditional | Available |
| BA25-50/I16-30 | β | MR Conditional | Available |
| BA25-50/I20-30 | β | MR Conditional | Available |
| BA25-60/I13-40 | β | MR Conditional | Available |
| BA25-60/I16-40 | β | MR Conditional | Available |
| BA25-60/I20-40 | β | MR Conditional | Available |
| BA25-70/I16-30 | β | MR Conditional | Available |
| BA25-70/I20-30 | β | MR Conditional | Available |
| BA25-80/I13-40 | β | MR Conditional | Available |
| BA25-80/I16-40 | β | MR Conditional | Available |
| BA25-80/I16-55 | β | MR Conditional | Available |
| BA25-80/I20-40 | β | MR Conditional | Available |
| BA25-80/I20-55 | β | MR Conditional | Available |
| BA25-90/I16-30 | β | MR Conditional | Available |
| BA25-90/I20-30 | β | MR Conditional | Available |
| BA25-100/I13-40 | β | MR Conditional | Available |
| BA25-100/I16-40 | β | MR Conditional | Available |
| BA25-100/I16-55 | β | MR Conditional | Available |
| BA25-100/I20-40 | β | MR Conditional | Available |
| BA25-100/I20-55 | β | MR Conditional | Available |
| BA25-110/I16-30 | β | MR Conditional | Available |
| BA25-110/I20-30 | β | MR Conditional | Available |
| BA25-120/I13-40 | β | MR Conditional | Available |
| BA25-120/I16-40 | β | MR Conditional | Available |
| BA25-120/I20-40 | β | MR Conditional | Available |
| BA28-40/I13-40 | β | MR Conditional | Available |
| BA28-40/I16-40 | β | MR Conditional | Available |
| BA28-40/I20-40 | β | MR Conditional | Available |
| BA28-50/I16-30 | β | MR Conditional | Available |
| BA28-50/I20-30 | β | MR Conditional | Available |
| BA28-60/I13-40 | β | MR Conditional | Available |
| BA28-60/I16-40 | β | MR Conditional | Available |
| BA28-60/I20-40 | β | MR Conditional | Available |
| BA28-70/I16-30 | β | MR Conditional | Available |
| BA28-70/I20-30 | β | MR Conditional | Available |
| BA28-80/I13-40 | β | MR Conditional | Available |
| BA28-80/I16-40 | β | MR Conditional | Available |
| BA28-80/I16-55 | β | MR Conditional | Available |
| BA28-80/I20-40 | β | MR Conditional | Available |
| BA28-80/I20-55 | β | MR Conditional | Available |
| BA28-90/I16-30 | β | MR Conditional | Available |
| BA28-90/I20-30 | β | MR Conditional | Available |
| BA28-100/I13-40 | β | MR Conditional | Available |
| BA28-100/I16-40 | β | MR Conditional | Available |
| BA28-100/I16-55 | β | MR Conditional | Available |
| BA28-100/I20-40 | β | MR Conditional | Available |
| BA28-100/I20-55 | β | MR Conditional | Available |
| BA28-110/I16-30 | β | MR Conditional | Available |
| BA28-110/I20-30 | β | MR Conditional | Available |
| BA28-120/I13-40 | β | MR Conditional | Available |
| BA28-120/I16-40 | β | MR Conditional | Available |
| BA28-120/I20-40 | β | MR Conditional | Available |
| I16-16/C55 | β | MR Conditional | Available |
| I16-16/C55 SA | β | MR Conditional | Available |
| I16-16/C55F | β | MR Conditional | Available |
| I16-16/C55F SA | β | MR Conditional | Available |
| I16-16/C88 | β | MR Conditional | Available |
| I16-16/C88 SA | β | MR Conditional | Available |
| I20-13/C70F | β | MR Conditional | Available |
| I20-13/C70F SA | β | MR Conditional | Available |
| I20-13/C88F | β | MR Conditional | Available |
| I20-13/C88F SA | β | MR Conditional | Available |
| I20-20/C55 | β | MR Conditional | Available |
| I20-20/C55 SA | β | MR Conditional | Available |
| I20-20/C55F | β | MR Conditional | Available |
| I20-20/C55F SA | β | MR Conditional | Available |
| IF20-25/C65 | β | MR Conditional | Available |
| IF20-25/C65 SA | β | MR Conditional | Available |
| IS20-25/C55 | β | MR Conditional | Available |
| IS20-25/C55 SA | β | MR Conditional | Available |
| IS20-25/C65 | β | MR Conditional | Available |
| IS20-25/C65 SA | β | MR Conditional | Available |
FDA clearances
- PMA P040002 February 2014
Procedures that use aortic stent grafts
Frequently asked questions
What is AFX Endovascular AAA System used for?
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
Who makes AFX Endovascular AAA System?
AFX Endovascular AAA System is made by Endologix LLC. It is listed under aortic stent grafts (evar/tevar) in our device library.
What sizes does AFX Endovascular AAA System come in?
The FDA device database does not list sizes for AFX Endovascular AAA System. Check the instructions for use or ask a Endologix LLC representative.
Is AFX Endovascular AAA System MRI safe?
The FDA device database lists AFX Endovascular AAA System as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is AFX Endovascular AAA System FDA cleared?
AFX Endovascular AAA System is covered by FDA submission P040002.
How do I contact a Endologix LLC sales representative?
Endologix LLC has not listed representatives on LA Vascular yet. Visit the Endologix LLC company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.