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.
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November 03, 2021 at 12:22AM
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FDA panel meets to review safety of endovascular graft device - Cardiovascular Business
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