Medtronic Endurant™ Stent Graft System Receives FDA Labeling Approval for Treatment of Ruptured Abdominal Aortic Aneurysms
Reuters
Oct 13
Medtronic Endurant™ Stent Graft System Receives FDA Labeling Approval for Treatment of Ruptured Abdominal Aortic Aneurysms
Medtronic plc has received U.S. Food and Drug Administration (FDA) labeling approval for its Endurant™ stent graft system, making it the first and only device of its kind to remove the treatment warning for ruptured abdominal aortic aneurysms (rAAA) from its Instructions for Use. This approval is based on new clinical evidence supporting the use of the Endurant stent graft system in emergency rAAA cases. The updated labeling provides physicians with greater confidence in using an endovascular option for this critical, high-risk condition, aligning the product with real-world clinical practices and training. No other organizations are mentioned as recipients of this regulatory approval.
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