FDA provides new information on risks for patients with endovascular grafts based on real-world data as the agency continues to monitor postmarket safety of these devices

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-provides-new-information-risks-patients-endovascular-grafts-based-real-world-data?utm_campaign=102819_FIB_FDA%20provides%20new%20information%20on%20risks%20for%20patients%20with%20endovascular%20grafts&utm_medium=email&utm_source=Eloqua

FDA provides new information on risks for patients with endovascular grafts based on real-world data as the agency continues to monitor postmarket safety of these devices

Today, the U.S. Food and Drug Administration issued a safety communication providing new information about its evaluation of the risk of blood continuing to leak into an aneurysm (an abnormal widening of an artery due to weakness in the wall of the blood vessel), called a “Type III endoleak,” when AFX endovascular grafts (flexible fabric tubes permanently implanted inside the largest blood vessel), made by the manufacturer Endologix, are used for the treatment of abdominal aortic aneurysm (AAA). There are three versions of the AFX endovascular graft made by Endologix that are approved by the FDA: AFX with Strata, AFX with Duraply, and AFX2. In June 2018, the FDA communicated about the greater risk of Type III endoleaks occurring with the Endologix AFX with Strata endovascular graft. Today’s safety communication is...

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