Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel
Company’s latest design fails to convince panel leakage issues have been fixed
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.
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A new letter to providers says that to ensure potential adverse events can be identified early, patients should be checked via imaging at 30 days after surgery and at least once a year thereafter.
In its most recent update on the use of Endoglox AFX endovascular grafts, the US FDA is advising physicians use other devices for treating patients with abdominal aortic aneurysms (AAA). AFX still poses bleeding risk.
Postmarket monitoring continues to show a consistent risk of type III endoleaks in patients with Endologix AFX grafts.