FDA approves key update for Medtronic’s Endurant stent graft system
Medtronic has received an important update from the U.S. Food and Drug Administration (FDA) to the labeling of its Endurant stent graft system.
Going forward, the FDA is allowing Medtronic to include clinical evidence related to the treatment of ruptured abdominal aortic aneurysm (rAAA) in the device’s labeling. In addition, Medtronic can now remove the rAAA treatment warning currently required to be included in the instructions for use (IFU) of the Endurant system and other similar devices.
The Endurant stent graft system has been used to treat abdominal aortic aneurysms for more than a decade now. It now stands as the first and only endovascular aneurysm repair (EVAR) system to receive this labeling update from the FDA.
“This landmark effort harnessed international, real-world data to evaluate the performance of endovascular devices in the treatment of rAAA,” Adam Beck, MD, director of the division of vascular surgery and endovascular therapy at the University of Alabama, said in a prepared statement. “The recent FDA labeling approval provides physicians with confidence in an endovascular treatment option for rAAA patients for the first time. This milestone validates the importance of rAAA, enabling continued medical education and support for physicians to safely treat these complex, high-acuity cases.”
“This important FDA labeling approval is a testament to the innovation, durability, and effectiveness behind the Endurant stent graft system,” added Simona Zannetti, MD, vice president and general manager of Medtronic’s aortic business. “We are proud to be the first company in the industry with the labeling approval to support treatment of rAAA, strengthening our ability to support physicians in confidently treating patients during critical emergencies.”
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.