đź“‹ FDA Reference
Aorfix Aa Flexible Stent Graft System
Product: Aorfix AAA Stent Graft Body with Aorflex Delivery System — all models and sizes
Summary: The Aorfix AA Flexible Stent Graft System is a medical device used in endovascular repair of abdominal aortic aneurysms. It is primarily utilized by vascular surgeons in hospital settings.
FDA Clearance Information
Pathway ?
PMA
Number ?
P110032 ↗
Decision Date ?
June 18, 2013
Product Code ?
MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Device Class ?
Class 3
Evidence ?
0 studies
The Aorfix AA Flexible Stent Graft System received FDA clearance through the PMA pathway on June 18, 2013. It is manufactured by Lombard Medical and is classified as a Class 3 medical device.
What It Is
The Aorfix AA Flexible Stent Graft System is an endovascular device designed to treat abdominal aortic aneurysms (AAA). It consists of a flexible stent graft that can conform to the natural curves of the aorta, allowing for effective sealing and support of the aneurysm. This flexibility is particularly beneficial in anatomies with high angulation, reducing the risk of endoleaks.
FDA-Cleared Indications
- The FDA record identifies the device for endovascular graft treatment of abdominal aortic aneurysms.
- The PMA record includes a modified sterilization cycle for the approved device.
Clinical Applications
- Endovascular repair of an abdominal aortic aneurysm.
- Placement of an aortic stent graft within the abdominal aorta to exclude an aneurysm from circulation.
- Treatment of an infrarenal abdominal aortic aneurysm when the patient's anatomy meets the device's approved sizing and anatomic requirements.
Practical Considerations
- Pre-procedure CT angiography is used to measure the aortic neck, aneurysm, iliac arteries and access vessels before selecting a device size.
- The graft is delivered through vascular access, usually through the common femoral arteries, and deployed under fluoroscopic guidance.
- The device must be used according to its current instructions for use, including approved diameters, lengths, landing zones and delivery-system requirements.
- MRI safety and scan conditions should be confirmed in the current manufacturer labeling; do not assume MRI compatibility without checking the device-specific instructions.
- Patients require lifelong imaging surveillance after endovascular aneurysm repair to assess graft position, endoleak, migration, limb patency and aneurysm size.
Frequently Asked Questions
What is the Aorfix AA Flexible Stent Graft System used for?
It is used for the endovascular repair of abdominal aortic aneurysms, particularly in patients with complex aortic anatomies.
What specialties typically use this device?
Vascular surgeons typically use this device in hospital settings or specialized vascular centers.
What are the FDA-cleared indications?
The device is indicated for the endovascular treatment of abdominal aortic aneurysms, especially in patients with challenging aortic anatomies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.