WCPO Cincinnati

Abdominal Aortic Aneurysm Repair Devices Recalled Due To High Rate of Failure

The FDA continues to investigate and urgently warn about the dangers posed by certain medical devices manufactured by Endologix Inc., specifically the AFX Endovascular AAA System. These devices are ...
TCTMD

FDA Reminder: Yearly, Lifelong Surveillance Needed for Endologix AAA Grafts

In a safety communication issued today, the US Food and Drug Administration is reminding physicians and patients of the need for lifelong imaging follow-up, on a yearly basis, for type III endoleaks ...
BioWorld

Endologix exits challenging month, resumes shipment of some AFX devices

Endologix Inc. has resumed shipping of some of its AFX endovascular abdominal aortic aneurysm systems, after placing the devices on hold. This brought an end to a rather tumultuous week for the Irvine ...
Nasdaq

Endologix, Inc. Comments on Recent FDA Update on Type III Endoleaks with AFX® Endovascular AAA System

Dr. Matt Thompson, Chief Medical Officer of Endologix Inc. commented, “On September 28, 2017, the FDA issued a letter to health care professionals (“HCPs”) regarding Type III endoleaks after ...
TCTMD

FDA Safety Communication Updates Stance on Endologix AAA Grafts

More than 2 years after serious concerns were raised about increased risk of endoleaks associated with Endologix AFX endovascular abdominal aortic aneurysm (AAA) graft systems, the US Food and Drug ...
BioWorld

FDA advisory panel sees a role for Endologix AFX devices despite FDA’s safety concerns

The FDA convened a Nov. 2 advisory panel to review the data for the AFX2 by Endologix LLC, of Irvine, Calif., with some indication that the agency believes the data suggest a poor benefit-risk ratio ...