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ELGX - Endologix defends safety record of AFX Endovascular devices
Endologix Inc.
Responding to the FDA's October 28 update on the risk of Type III endoleaks (overlapping stent graft components separate allowing pressurized blood flow to enter the aneurysm cavity) with its AFX Strata System, Endologix (NASDAQ:ELGX) points out the limitations of the cited data (2.5% cumulative Type III endoleak rate at year 2 for the period of 2011 - 2017), including the small number of patients receiving the AFX2 device (n=32), the results not being stratified by Type IIIa (disconnection between the main body and the contralateral limb) and Type IIIb (defeat in the graft due to fabric defects) endoleaks and the lack of comparison with other endovascular graft systems.
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