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.
The FDA is advising anyone with any Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) to visit a doctor at least once a year to be checked for leaks.
Another Endologix product — the Ovation iX abdominal stent graft system — was the subject of a Class I recall last year including five deaths, though Endologix clarified that two of the five deaths took place following complications after a polymer leak. Endologix in 2020 also filed for Chapter 11 bankruptcy protection and simultaneously agreed to be purchased by its largest creditor and go private.
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.