Bleeding Risk For Endologix AAA Grafts Reconfirmed
Patients with the grafts should undergo imaging scans each year, US FDA says
Postmarket monitoring continues to show a consistent risk of type III endoleaks in patients with Endologix AFX grafts.
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The US agency’s Circulatory System Devices Panel found type III endoleaks are still a problem for abdominal aortic aneurysm patients treated with the newest Endologix stent graft, though for some the benefits still outweigh the risks. The panel advised that all patients, however, should continue getting annual screenings.
A recent warning from the US agency ties two additional models of AFX endovascular grafts from Endologix Inc. to potentially fatal blood leaks. An earlier model of the devices, which are used to treat abdominal aortic aneurysms, was removed from the market last year over similar concerns.
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.