FDA updates advisory letter on device-related type III endoleak risks


An update to last year’s FDA letter, expressing concern over risk of type III endoleaks in relation to endovascular graft systems, now states that the increased risk is specific to one device which was discontinued in 2014.

Endologix’ AFX Strata, an endovascular graft system indicated for endovascular aneurysm repair (EVAR), ceased to be manufactured by the company in 2014. In December 2016, Endologix issued a recall of the “small remaining quantity” of AFX Strata devices remaining in hospital inventories. However, the FDA highlight, the device is still in use in patients who had it implanted prior to discontinuation or recall.

The FDA’s original 2017 letter described an increase in type III endoleaks reported by several sources including the Administration’s own Medical Device Reporting (MDR) system and manufacturers’ Annual Clinical Updates to Physicians. The increased risks were associated with EVAR and endovascular graft systems, but the FDA were not specific as to which systems could be affected, instead recommending reports of adverse events from physicians and manufacturer compliance with MDR regulations and reporting requirements.

Since the 2017 letter, the FDA now write, the increased risks were narrowed down to the AFX Strata based on new information, observing “greater risk for a type III endoleak compared to other endovascular abdominal aortic aneurysm (AAA) graft systems.

Type IIIa endoleaks were, as estimated by Endologix, 0.9% at two years and 5% at five years, while type IIIb endoleak rates were 0.66% at two years and 2.4% at five years. “Because these estimates are calculated using voluntary reporting and units sold, the rate estimates may be low compared to the true endoleak event rates”, the FDA write.

Matt Thompson, chief medical officer for Endologix, says, “The FDA update does not disclose risks beyond those already communicated to health care practitioners in safety notice issued by Endologix in December 2016, which requested that all remaining AFX Strata devices be returned from the field and emphasised the fact that Endologix has not manufactured AFX Strata grafts since 2014.”

“Endologix is committed to working collaboratively with the FDA,” comments John Onopchenko, the company’s chief executive officer. “Our current commercially available versions of the AFX system, the AFX Duraply and AFX2 products, are manufactured using a different ePTFE processing methodology and include additional product improvements. These AFX Duraply and AFX2 products are not the subject of today’s FDA-issued awareness notification. Through our comprehensive system of post-market surveillance, anonymised registry data, and the only randomised trial to compare EVAR systems (the LEOPARD trial), we have a strong, growing evidence base that supports the use of the AFX Duraply and AFX2 systems for patients with AAA. We are proud of, and committed to, advancing our collaborative work with the FDA on behalf of our patients, customers, and the broader clinical community.”

At this time, the FDA advise health care providers monitor affected patients and ensure annual follow-up to monitor for type III endoleaks. “The FDA continues to work collaboratively with Endologix,” they write, “to assess the treatment options for patients with the AFX with Strata device and type III endoleaks, and to provide further instructions in the labelling on this concern.”



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