FDA Issues Updated Safety Communication on the Endologix AFX AAA Graft System

January 13, 2022—The FDA has issued a Safety Communication on the risk of type III endoleaks with use of the Endologix AFX endovascular abdominal aortic aneurysm (AAA) graft systems. The latest document updates the previous Safety Communication that was announced in December 2020 on the use of AFX endovascular grafts.

The current update includes a summary of information from the FDA’s November 2021 advisory committee meeting, reported here, as well as new recommendations to health care providers who treat patients with AAA using the currently available AFX product—the AFX2.

The FDA noted that during the November 2 meeting of the Circulatory System Devices Panel of the Medical Device Advisory Committee of the Center for Devices & Radiological Health, participants shared information and perspectives on the benefits and risks of the Endologix AFX endovascular graft system that focused on the risk of type III endoleaks.

At that meeting, most committee members recommended that AFX2 endovascular grafts should not be used for routine AAA treatment.

Most committee members supported continued availability of the device for select populations, to be identified based on additional data collection and evaluation, and in situations when alternative treatment options are insufficient or not available.

Based on the FDA’s analysis and advisory committee input, the FDA recommends health care providers consider using available alternative treatment options for AAA patients rather than the AFX2 device.

The communication advises that the FDA is taking additional steps to address type III endoleak risks associated with AFX endovascular grafts, including working with the manufacturer to identify patients who may benefit from treatment with the AFX2 device and to update the device labeling. The FDA continues to work with the manufacturer on additional data collection and evaluation to assess the long-term safety of AFX endovascular grafts.

As outlined in the FDA Safety Communication, the recommendations for patients who have or are considering an Endologix AFX endovascular graft system for treatment of AAAs, including AFX with Strata, AFX with Duraply, or AFX2, include:

• At least yearly, lifelong follow-up with a health care provider for all patients who have had their AAA treated with any AFX endovascular graft system (AFX with Strata, AFX with Duraply, or AFX2) to monitor for type III endoleaks.
• Before surgery, patients should discuss the benefits and risks of all available AAA treatment options with their health care provider. If your provider recommends AAA treatment with the AFX2 endovascular graft, ask the provider to explain why they believe it is an appropriate treatment option for you.

The FDA’s recommendations for patients from the December 2020 safety communication have not changed.

Health care providers who treat patients with AAA should consider the following new FDA recommendations for the AFX2 device:

• Before surgery, discuss the risks and benefits of all available AAA treatment options with patients.
• Be aware that the majority of available data show that previous AFX endovascular graft versions (AFX with Strata and AFX with Duraply) are associated with an increased risk of type III endoleaks or a higher risk of late AAA-related serious adverse events compared to other commercially available AAA endovascular grafts. Currently, it is uncertain whether the increased type III endoleak risk has been addressed by the currently marketed AFX2 device.
• For AAA patients undergoing endovascular graft treatment, consider available alternative options to the AFX2 device.
• Remain alert for further updates and recommendations from Endologix and the FDA.

The FDA is working with Endologix to provide further instructions in product labeling about the safety of the AFX endovascular graft system and new information to help identify selected patients who may benefit from treatment with the AFX2 device.

Finally, the communication notes that the FDA continues to recommend the following for health care providers:

• Closely monitor patients who have undergone implantation with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) and evaluate their risk profile for type III endoleaks per the Instructions for Use.
  • Ensure at least yearly, lifelong imaging follow-up to monitor for the development of type III endoleaks and aneurysm expansion for patients who have undergone implantation with any AFX endovascular graft.
  • Urgently evaluate patients with type III endoleaks to assess the need for additional endovascular or surgical procedures.