Medtronic Earns FDA Labeling for Endurant Stent Graft
Medtronic announced 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 can cause severe internal bleeding and requires emergency surgical intervention, with a mortality rate exceeding 80%.
Medtronic says this could empower physicians to act confidently in emergency cases.
Now, Endurant can offer an option in these emergency cases.
Author's summary: Medtronic receives FDA approval for Endurant stent graft.
- First company to remove rAAA warning from stent graft instructions
- Endurant offers option for emergency rAAA cases