Yesterday FDA released a safety communication that provided an update of the agency’s evaluation of the risk of an aneurysm called Type III endoleaks connected to the implantation of AFX endovascular grafts. Used to treat abdominal aortic aneurysms (AAA), these particular grafts are manufactured by Endologix.
One major issue is that the endoleaks can happen after a repair with a graft and without any symptoms. A Type III endoleak can also result in expansion and rupture of the AAA, causing serious injury or death.
“The FDA strongly recommends, at least yearly, lifelong follow-up visits for all patients implanted with any Endologix AFX endovascular grafts (AFX with Strata, AFX with Duraply or AFX2) with their doctor to ensure the devices are working properly,” FDA stated in its most recent communication.
In June 2018 FDA issued an alert to healthcare providers warning them of the Type III Endoleaks [https://www.fda.gov/medical-devices/letters-health-care-providers/update-type-iii-endoleaks-associated-endovascular-graft-systems-letter-health-care-providers] and in October 2018 Endologix recalled more than 61,000 AAA systems due to the endoleak risk.
Endologix issued its own response to FDA’s announcement, defending the safety of the AFX devices, because the products are manufactured using a different ePTFE processing method, along with other product improvements. “…Changes to the ePTFE manufacturing process from Strata to Duraply, along with the AFX IFU updates, are associated with a reduction in the occurrence of Type III endoleaks for the AFX System,” said John Onopchenko, CEO of Endologix. “This finding is different from the Rothenberg et. al presentation at the American College of Surgeons, but we regard our datasets as being robust, prospectively collected, and with active contemporary comparators to set the results into appropriate context.” The Rothenberg presentation to which Onopchenko is referring is an abstract published in the Journal of the American College of Surgeons that includes data suggesting a “higher than expected risk” of Type III endoleaks associated with using the AFX endovascular grafts.
According to FDA, the agency is working with Endologix to provide labeling instructions for the AFX grafts about the endoleaks.
Related Articles
-
There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
