Discontinued Endologix AAA Graft Device Singled Out In Updated FDA Alert
Executive Summary
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.
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Bleeding Risk For Endologix AAA Grafts Reconfirmed
Postmarket monitoring continues to show a consistent risk of type III endoleaks in patients with Endologix AFX grafts.
Leak Risk Tied To Endologix Grafts Found In More Models, FDA Says
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.
Endologix Lifts Hold On Shipments Of AAA Devices
The Dec. 29 announcement relating to non-EU shipments of AFX and some AFX2 AAA repair devices came two days after the company said it suspended shipments of its flagship system because a manufacturing issue was causing damage to some devices. The release of the hold allowed the company to end a difficult month on a positive note. Endologix announced the suspension of the CE mark for AFX and AFX2 in Europe earlier in December.