FDA approves labeling change for Gore EVAR devices
The U.S. Food and Drug Administration (FDA) has approved updated labeling for two Gore devices used to perform endovascular aneurysm repair (EVAR) on patients with abdominal aortic aneurysms (AAAs). The new labeling is a response to recent research highlighting the effectiveness of these devices when treating ruptured AAAs.
The previous labeling for Gore’s Excluder AAA Endoprosthesis and Excluder Comformable AAA Endoprosthesis included a mandatory warning that said the devices had not been evaluated for patients with ruptured aneurysms. Now, however, that warning has been removed, and new data have been added showing that the devices have been linked to positive outcomes for that population.
“This FDA labeling update is an important step forward for physicians treating ruptured abdominal aortic aneurysms—one of the most challenging conditions in vascular care,” Jason Belzer, business leader for Gore Americas, said in a statement. “We are proud to see the Excluder AAA Endoprosthesis and the Excluder Conformable AAA Endoprosthesis labeling change reflect the growing clinical evidence and support confident decision-making for physicians treating patients in urgent, life threatening situations.”
“In emergent ruptured AAA, access to proven devices with clear labeling is critical,” added Alyssa Pyun, MD, a clinician with the division of vascular surgery and endovascular therapy at the University of Southern California. “This update reflects growing clinical experience with these devices and supports physicians caring for patients with complex and urgent aortic disease.”
According to Gore, real-world registry data on these devices point to a procedural technical success rate of 100% as well as a low mortality rate through two years and limited device-related reinterventions.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.