FDA: New Concerns Surface With Endologix Grafts for AAA

(UPDATED) The US Food and Drug Administration today issued a safety communication to physicians and patients regarding Endologix AFX endovascular grafts following new concerns.

Those concerns, notes the agency, were raised in an abstract presented at a meeting over the weekend.

Two years ago, the FDA issued a warning about rising rates of type IIIa and IIIb endoleaks after endovascular aneurysm repair of abdominal aortic aneurysms (AAA) and aorto-iliac aneurysms based on the number of cases being reported through the Medical Device Reporting system database. In 2018 the agency concluded that the phenomenon was specific to the AFX with Strata device manufactured by Endologix (Irvine, CA). However, just 4 months later a Class I recall was issued for all AFX Endovascular AAA Systems by Endologix following a voluntary recall action by the company. At the time, both the agency and the company acknowledged that while most of the endoleaks were associated with the AFX with Strata, it was unclear if Endologix’s other two systems were associated with a lower rate of endoleak or had simply been on the market too short a time to show an increased risk.

Now, in its latest safety communication, the FDA says it is evaluating new information suggesting those two other Endologix grafts—AFX with Duraply and AFX2—also are associated with “a higher than expected” risk of type III endoleak.

The new signal of risks with all three of the devices comes from prospective registry data and indicates that there is a 2.5% cumulative probability that patients with any of the Endologix grafts may need additional procedures to treat type III endoleaks at 2 years of follow-up (95% CI 1.5-4.2). The data were presented as an abstract at the American College of Surgeons’ Clinical Congress 2019.

“The FDA recognizes the limitations of the data presented in the abstract, including the small number of patients with AFX2 (n = 32 patients with AFX2; n = 197 patients with AFX with Duraply; n = 374 patients with AFX with Strata), the results not being stratified by type IIIa and type IIIb endoleak, and no comparison of the results to other endovascular graft systems,” the agency’s safety communication states. “However, the abstract provides published results from the largest US cohort of patients receiving Endologix AFX endovascular grafts.”

Additionally, the FDA said it is also evaluating early postmarket data comparing the risk of type III endoleaks with Endologix AFX endovascular grafts to other available endovascular graft systems. As with the agency’s prior communications on this issue, the FDA reiterated that patients who have previously undergone implantation with any AFX endovascular graft require close monitoring and evaluation for risk of type III endoleaks. This agency recommends “yearly imaging follow-up at a minimum to monitor for the development of type III endoleaks and aneurysm expansion” and “a benefit-risk determination for each individual patient . . . to assess the need for additional procedures related to the risk of developing type III endoleaks.”

In a press release issued in response to the safety communication, Endologix said they believe the small number of patients included in the abstract “prevents any clinically meaningful interpretation of these findings.” The company added that the current commercially available versions of the AFX System—the AFX with Duraply and AFX2—are manufactured using a different graft processing methodology than is used for the AFX Strata. They further note that data from the LEOPARD trial, a vascular registry, benchmarked medical device reporting complaint data, and meta-analyses of current literature “support our conclusion that changes to the ePTFE manufacturing process from Strata to Duraply, along with the AFX [instructions for use] updates, are associated with a reduction in the occurrence of Type III endoleaks for the AFX System.”