FDA Issues Safety Alert for Endologix AAA Duraply Repair Grafts

Megan Brooks

October 28, 2019

There may be a "higher than expected" risk for type III endoleaks with two more Endologix endovascular grafts used to repair of abdominal aortic aneurysm (AAA), the US Food and Drug Administration (FDA) said in a safety alert issued today.

In a June 2018 safety alert, the FDA warned that the Endologix AFX endovascular graft system with Strata graft material is at greater risk for type III endoleaks than other endovascular aneurysm repair systems for AAA, as previously reported by Medscape Medical News.

In today's safety alert, the FDA said it is evaluating recent real-world data published as an abstract at the American College of Surgeons' Clinical Congress 2019, which point to a higher than expected risk for type III endoleaks occurring in patients treated for an AAA with AFX endovascular grafts that use Duraply graft material (Endologix AFX with Duraply and Endologix AFX2).

The abstract presents prospective registry data from an integrated healthcare system that suggest an early type III endoleak risk for all AFX endovascular grafts, the FDA notes.

According to the abstract data, there was a 2.5% cumulative probability of additional procedures needed to treat type III endoleaks at 2 years of follow-up for patients with AFX endovascular grafts (95% CI, 1.5 - 4.2).

The FDA acknowledges several limitations of the data presented in the abstract, including the smaller number of patients with AFX2 (32 patients) and AFX with Duraply (197 patients) than with AFX with Strata (374 patients). Also, the results are not stratified by type IIIa and type IIIb endoleaks, and there is no comparison of the results with other endovascular graft systems.

Despite these limitations, it provides published results from the largest American cohort of patients receiving Endologix AFX endovascular grafts, the FDA notes.

The agency also notes that because the AFX endovascular graft devices with Duraply (AFX with Duraply and AFX2) have been distributed for a shorter time than the AFX with Strata endovascular graft, longer-term follow-up of patients with the Duraply grafts is needed to fully define the risk for type III endoleaks with these products.

The AFX endovascular graft was first approved by the FDA in 2011 and over time, Endologix has made changes to the device resulting in the three versions of the device being implanted in patients.

The AFX with Strata graft material was implanted between 2011 and 2016, but is no longer available after the company requested that all AFX with Strata devices be pulled from hospital inventory because of an increase in type III endoleaks.

The AFX with Duraply graft material has been used since July 2014. The change in graft material (from Strata to Duraply) was intended to help prevent endoleaks.

The AFX2, also using Duraply graft material, has been used since February 2016. With AFX2, changes were made to the way Duraply graft material is made to increase average thickness and further help prevent endoleaks.

The FDA recommends "lifelong follow-up for patients treated with any endovascular graft. However, while we continue our evaluation, we are emphasizing the importance of at least yearly, lifelong follow-up for all patients who have any type of Endologix AFX endovascular graft in order to monitor for Type III endoleaks," the agency said.


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