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.
It could empower physicians to act confidently in emergency cases.
A ruptured AAA can cause severe internal bleeding and requires emergency surgical intervention, with a mortality rate exceeding 80%.
Now, Endurant can offer an option in these emergency cases.
Author summary: Medtronic receives FDA approval.
- Medtronic (NYSE: MDT) received new labeling approval from the FDA.
- The Endurant stent graft system can now be used in emergency cases.
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