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Discontinued Endologix AAA Graft Device Singled Out In Updated FDA Alert

 
• By David Filmore

US FDA says that previously identified elevated risks of type III endoleaks from endovascular aneurysm repair systems appears to be linked to a specific, no-longer-sold device, Endogix's AFX with Strata system.

Last fall, FDA circulated findings that rates of a particular type of adverse event were higher than expected for endovascular graft systems intended to repair abdominal aortic aneurysms (AAA). Now the agency says the problem appears to be linked only to one specific device that was previously removed from the market.

Endovascular aneurysm repair (EVAR) devices are intended to exclude the AAA sac from the arterial circulation and prevent the aneurysm...

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