Medtronic recently announced it has received US Food and Drug Administration (FDA) labelling approval for the Endurant stent graft system, by adding ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removing the rAAA treatment warning. A press release notes that this FDA labelling approval makes Medtronic the “first and only” company to remove the rAAA warning from its stent graft system instructions for use (IFU).
“This landmark effort harnessed international, real-world data to evaluate the performance of endovascular devices in the treatment of ruptured abdominal aortic aneurysms. The recent FDA labelling approval provides physicians with confidence in an endovascular treatment option for rAAA patients for the first time,” said Adam Beck (University of Alabama at Birmingham, Birmingham, USA). “This milestone validates the importance of rAAA, enabling continued medical education and support for physicians to safely treat these complex, high-acuity cases.”
Medtronic notes that the Endurant is backed by over a decade of clinical evidence from the ENGAGE 10-year global registry to demonstrate safe and effective use.
“This important FDA labelling approval is a testament to the innovation, durability, and effectiveness behind the Endurant stent graft system,” said Simona Zannetti, vice president and general manager of Aortic, part of the Cardiovascular portfolio at Medtronic. “We are proud to be the first company in the industry with the labelling approval to support treatment of rAAA, strengthening our ability to support physicians in confidently treating patients during critical emergencies.”
