Medtronic (NYSE: MDT) announced today that it received new labeling approval from the FDA for its Endurant stent graft system.
The new labeling adds ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removes the rAAA treatment warning. This makes Medtronic the first and only company to remove the rAAA warning from stent graft instructions for use, the company said. It could empower physicians to act confidently in emergency cases, Medtronic says.
A ruptured AAA occurs when the main artery in the abdomen bursts. It can cause severe internal bleeding and require emergency surgical intervention. According to a news release, the mortality rate from a ruptured abdominal aortic aneurysm exceeds 80%. Now, Endurant can offer an option in these emergency cases.
Medtronic — one of the largest medtech companies in the world — began offering Endurant more than a decade ago. It treats AAA through a minimally invasive endovascular repair (EVAR) method. The company says it’s the first and only EVAR system with a decade of global registry outcomes.
Dr. Adam Beck serves as director of the division of Vascular Surgery and Endovascular Therapy at the University of Alabama. Beck says the new labeling “provides physicians with confidence in an endovascular treatment option for rAAA patients for the first time.”
“This important FDA labeling approval is a testament to the innovation, durability, and effectiveness behind the Endurant stent graft system,” said Dr. Simona Zannetti, VP and GM of Aortic, part of the Cardiovascular Portfolio at Medtronic. “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.”
