Aortic stent grafts
Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery 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.
Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery 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 |
|---|---|---|---|
| SG-HDE-10-51-A13-20 | — | MR Conditional | Available |
| SG-HDE-10-82-A13-20 | — | MR Conditional | Available |
| SG-HDE-12-51-A13-20 | — | MR Conditional | Available |
| SG-HDE-12-82-A13-20 | — | MR Conditional | Available |
| SG-HDE-14-51-A13-20 | — | MR Conditional | Available |
| SG-HDE-14-82-A13-20 | — | MR Conditional | Available |
| SG-HDE-16-51-A13-20 | — | MR Conditional | Available |
| SG-HDE-16-82-A13-20 | — | MR Conditional | Available |
| SG-HDE-18-51-A13-20 | — | MR Conditional | Available |
| SG-HDE-18-82-A13-20 | — | MR Conditional | Available |
| SG-HDE-20-51-A13-20 | — | MR Conditional | Available |
| SG-HDE-20-82-A13-20 | — | MR Conditional | Available |
FDA clearances
- PMA P110032 June 2013
Procedures that use aortic stent grafts
Frequently asked questions
What is Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery 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 Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System?
Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System is made by Lombard Medical Limited. It is listed under aortic stent grafts (evar/tevar) in our device library.
What sizes does Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System come in?
The FDA device database does not list sizes for Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System. Check the instructions for use or ask a Lombard Medical Limited representative.
Is Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System MRI safe?
The FDA device database lists Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System FDA cleared?
Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System is covered by FDA submission P110032.
How do I contact a Lombard Medical Limited sales representative?
Lombard Medical Limited has not listed representatives on LA Vascular yet. Visit the Lombard Medical Limited 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.