FDA warns on leak risk with discontinued Endologix stent graft

The FDA yesterday warned of an increased risk of serious endoleaks with a discontinued stent graft once made by Endologix (NSDQ:ELGX).

Last September the federal safety watchdog warned physicians about the risk of endoleaks with stent grafts used to wall off aneurysms in the abdominal aorta.

The FDA said at the time that the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent grafts used to treat AAA and aorto-iliac-aneurysms. Type III endoleaks result from defects or mis-alignment of the stent graft components, allowing pressure to build in the aneurysm sac and increasing the risk of rupture.

The federal safety watchdog said yesterday that the Endologix AFX device made with a graft material called Strata poses a greater risk of Type III endoleaks compared with other devices.

Endologix stopped making the AFX with Strata graft material in July 2014 and recalled all of the devices in December 2016, the FDA said.

The agency urged physicians to closely monitor patients implanted with the AFX with Strata device and to ensure follow-up visits at least once a year to check for Type III endoleaks.

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