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Home » FDA committee to examine safety of endovascular stent grafts

FDA committee to examine safety of endovascular stent grafts

March 30, 2021 By Chris Newmarker

AFX Endovascular AAA System endovascular stent grafts FDA
AFX Endovascular AAA system [Image courtesy of Endologix]
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.

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.

 

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Stents Tagged With: Cook Medical, Endologix, FDA, Medtronic, Terumo

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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