FDA reiterates importance of yearly, lifelong follow-up for Endologix AAA grafts
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The FDA issued a safety communication to remind patients and health care providers of the importance of at least yearly, lifelong follow-up for patients with Endologix AFX endovascular grafts, to monitor for type III endoleaks.
The recommendation applies to all patients with abdominal aortic aneurysm who received any type of Endologix AFX endovascular graft, including the AFX with Strata, AFX with Duraply or AFX2, according to the safety communication.
The FDA recommendation was announced in an October 2019 safety communication and has not changed since.
In addition, the FDA will convene an advisory committee meeting of the Circulatory System Devices Panel in 2021 to discuss the risk for type III endoleaks for AFX endovascular grafts, type III endoleak treatment options for patients with AFX devices and future postmarketing surveillance strategies for all endovascular grafts used for the treatment of AAA.
Meantime, the FDA continues to recommend yearly, lifelong follow-up for all patients with any AFX endovascular graft system. Moreover, it recommends that patients and health care providers are aware that the FDA has approved endovascular grafts made by various manufacturers for the treatment of AAA and that each device has specific benefits and risks, according to the statement. Patients and health care providers should discuss benefits and risks of all available AAA treatment options before surgery, according to the safety communication.
Due to ongoing concerns, the FDA stated it is committed to obtaining additional postmarket data to better understand the risk for type III endoleaks for AFX endovascular grafts.
Patients previously treated with the AFX with Strata endovascular graft are at greater risk for a type III endoleak compared with other endovascular graft systems, according to the FDA. Endologix has not manufactured the AFX with Strata graft material since 2014.
The FDA continues to evaluate new information that has suggested risk for type III endoleaks occurring with the use of AFX endovascular grafts with Duraply graft material (AFX or Duraply or AFX2) may be higher than expected, according to the safety communication. The safety communication addressed real-world data from a trial published in the Journal of Vascular Surgery in July. In the prospective registry of U.S. patients with AAA who received an AFX endovascular graft with Duraply graft material, the incidence of type III endoleaks at 2 years was 4% for patients with the AFX with Strata device and 5.1% for patients with the AFX with Duraply device. The incidence of type III endoleaks at 2 years was 14.1% for patients with the AFX2 device. The FDA said it recognizes limitations of these data but noted that it provides published results from the largest cohort of patients that received Endologix AFX endovascular grafts, according to the safety communication.
In addition, the FDA said it is aware of results of two recent conference abstracts that reported risk for major complications was similar for AFX with Duraply and AFX with Strata devices. One abstract reported major complications in 25% of patients with an AFX device at 4 years and the other reported major complications in 22% at 3 years; both reported similar risk between the different devices. The FDA said it recognizes limitations of the real-world data, but noted that both abstracts concluded patients with AFX devices should receive close monitoring, according to the safety communication.
Finally, the FDA continues to review data provided by Endologix from the ongoing LEOPARD trial of AAA patients randomly assigned an AFX endovascular graft device with Duraply or an FDA-approved endovascular device from other manufacturers.
The FDA concluded that there is a need for continued evaluation of real-world data on the risk for type III endoleaks for AFX endovascular grafts with Duraply graft material compared with AFX endovascular grafts with Strata and compared with other endovascular graft systems. The agency will gather and analyze additional real-world postmarket data on the longer-term outcomes of AFX endovascular grafts.
Read more information in the FDA safety communication.
Details on the date, location and agenda of the upcoming advisory committee meeting will be announced in the first quarter of 2021, according to the statement.
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