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aorfix aa flexible stent graft system
Lombard Medical
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
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.
Clinical Applications
This device is commonly used in the endovascular repair of abdominal aortic aneurysms, especially in patients with tortuous or highly angulated aortic anatomies. Vascular surgeons typically employ this system in hospital operating rooms or specialized vascular centers. It is suitable for patients who are at high risk for open surgical repair due to comorbidities or anatomical challenges.
Indications for Use
The FDA-cleared indication for the Aorfix AA Flexible Stent Graft System is for the endovascular treatment of abdominal aortic aneurysms. It is specifically indicated for patients with complex aortic anatomies that may not be suitable for other stent graft systems.
Practical Considerations
The Aorfix AA system offers a range of sizes to accommodate different patient anatomies. It is compatible with standard endovascular techniques and requires careful pre-procedural imaging to ensure appropriate sizing and placement. Clinicians should be aware of the device's flexibility, which aids in navigating challenging anatomies.
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.