Medtronic's Endurant Stent Graft System Becomes First and Only to Receive FDA Labeling Approval for Ruptured Abdominal Aortic Aneurysm Treatment

Yesterday, Medtronic announced that its Endurant Stent Graft System has received new label approval from the FDA.

The new label adds clinical evidence of ruptured abdominal aortic aneurysm (rAAA) and removes the rAAA treatment warning.

Thus, Medtronic has become the first and only company to remove the rAAA warning from the instructions for use of stent grafts.Medtronic stated that this can enable doctors to act with greater confidence in emergency situations.

Endurant Stent Graft System

Abdominal Aortic Aneurysm (AAA) is the dilation of the abdominal portion of the aorta, which is the largest artery in the body.

Rupture and dissection of AAA are life-threatening conditions that can cause severe hypotension, dizziness, tachycardia, and sudden, intense abdominal pain.If not identified and appropriately treated, it will lead to severe morbidity and mortality.According to the press release, the mortality rate of ruptured abdominal aortic aneurysms exceeds 80%.Now, Endurant can offer a treatment option for these emergencies.

It is reported that Medtronic started providing the Endurant system more than a decade ago. The system treats AAA through an endovascular aneurysm repair (EVAR) method. The company stated,This is the first and only EVAR system with ten years of global registration results.

Dr. Beck, director of the Division of Vascular Surgery and Endovascular Therapy at the University of Alabama, stated that the new label "gives physicians confidence for the first time in endovascular treatment options for rAAA patients."

Simona Zannetti, Ph.D., Vice President and General Manager of the Aortic Valve Business within Medtronic's Cardiovascular Portfolio, said: "This important FDA label approval demonstrates the innovation, durability, and effectiveness of the Endurant stent graft system."We are honored to be the first company in the industry to receive approval for the rAAA treatment label, which will enhance our ability to support doctors in confidently treating patients in critical situations."