FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies.
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.