The FDA’s Circulatory System Devices Panel is meeting Nov. 2 and Nov. 3 to discuss the overall safety of an endovascular graft system manufactured by Endologix.
The company’s AFX Endovascular AAA System was designed to treat patients with abdominal aortic aneurysms (AAAs). Earlier versions of the system were associated with endoleaks in the past—there was a Class I recall in 2018, for instance—and the FDA is hoping to evaluate the risks and benefits associated with these systems as they stand today.
The FDA and Endologix both prepared executive summaries ahead of the meeting. Those files, as well as other related documents, are available here.
In its own assessment of the ongoing situation, Endologix “acknowledges that the early iteration of the AFX product line” was previously linked to “clinically relevant” issues with endoleaks. The company said, however, that the latest iteration of its system—known as AFX2—is a “safe and effective device for use in the treatment of AAA.”
The FDA, meanwhile, said that its review and discussion of the situation “will inform the agency’s future actions with regard to this post-market safety concern.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.