Medtronic Earns First-of-Its-Kind FDA Labeling
Medtronic announced that it received new labeling approval from the FDA for its Endurant stent graft system.
The new labeling adds clinical evidence for ruptured abdominal aortic aneurysm (rAAA) and removes the rAAA treatment warning, making Medtronic the first company to do so.
A ruptured AAA occurs when the main artery in the abdomen bursts, causing severe internal bleeding and requiring emergency surgical intervention.
According to Medtronic, this change could empower physicians to act confidently in emergency cases, as the mortality rate from a ruptured abdominal aortic aneurysm exceeds 80%.
Now, Endurant can offer an option in these emergency cases.
Author's summary: Medtronic receives FDA approval for Endurant stent graft system.