Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood leakage called a Type III endoleak, according to an updated FDA announcement. Endologix has found itself having to vigorously defend itself against studies claiming a problem.
On its second day of meetings, the FDA advisory committee panel will discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts in general — with an emphasis on strengthening real-world data collection on the devices’ long-term performance. Other companies in the endovascular stent grafts space include Cook Medical, Medtronic and Terumo.
