Endologix AFX2 Graft Risk Information Updated in FDA-Approved Labeling
The FDA is requiring a post-market study by Endologix to determine AFX2 Graft System risks
The FDA is requiring a post-market study by Endologix to determine AFX2 Graft System risks
Gender bias and discrimination likely play a role in women having worse outcomes following aortic aneurysm repair surgery, researchers warn.
The FDA estimates up to 30% of abdominal aortic aneurysm repair patients will suffer device failures and need additional life-saving surgery at some point in their life.
This is the latest in a string of stent graft system warnings by the FDA, due to the risk of potentially fatal endoleaks.