FDA Clears Medtronic’s Endurant Stent Graft to Drop rAAA Warning

Medtronic has obtained U.S. Food and Drug Administration (FDA) approval to remove the ruptured abdominal aortic aneurysm (rAAA) treatment warning from its Endurant stent graft system and adding rAAA clinical evidence.

The company lauds this achievement as the first to remove the rAAA warning from its stent graft’s Instructions for Use (IFU). Medtronic said the FDA nod helps it align real-world innovation with real-world practices.

A ruptured AAA occurs when the abdomen’s main artery bursts, causing critical bleeding and requiring emergency surgery. About 80% of patients die from the condition.

Dr. Adam Beck, MD, FACS, director of the division of Vascular Surgery and Endovascular Therapy at the University of Alabama said Endurant stent’s milestone validates rAAA’s importance and allows further education and support for surgeons to treat the cases.

“This landmark effort harnessed international, real-world data to evaluate the performance of endovascular devices in the treatment of ruptured abdominal aortic aneurysms (rAAA),” Dr. Beck told the press. “The recent FDA labeling approval provides physicians with confidence in an endovascular treatment option for rAAA patients for the first time.”

The Endurant stent graft has been used in half a million patients around the world over its decade-plus availability, per Medtronic data. The minimally invasive endovascular aneurysm repair (EVAR) system boasts a decade of global outcomes from its ENGAGE global registry.

“This important FDA labeling approval is a testament to the innovation, durability, and effectiveness behind the Endurant stent graft system,” said 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.”