FDA Updates Plans for CDRH Advisory Committee Meeting on Endologix AFX Devices

March 29, 2021—The FDA issued an update of its plans to hold a virtual 2-day meeting of the CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee in Q4 of 2021. This meeting will be announced in the Federal Register to provide further details.

The FDA initially announced the meeting in December 2020. In that announcement, the FDA advised that the panel will discuss the type III endoleak risk for AFX endovascular grafts (Endologix), the type III endoleak treatment options for patients who are implanted with AFX devices, and future postmarket surveillance strategies for all endovascular grafts used for the treatment of abdominal aortic aneurysms.

Also in the December 2020 announcement, the FDA stated that it is updating the October 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2) to provide new data and review current recommendations.

The current FDA update advised that on Day 1 of the panel meeting the committee intends to discuss and make recommendations on information about the benefit-risk profile of the Endologix AFX endovascular graft system with regard to the risk of type III endoleaks. The FDA intends to request panel feedback on the totality of data collected on AFX devices and whether further actions are necessary.

On Day 2, the committee intends to discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts and how to strengthen real-world data collection on long-term performance of the devices, both for currently marketed devices and for future technologies.

The FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration. Additionally, the FDA intends to seek input on data collection platforms, and how to incentivize and optimize real-world data collection.