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# Medtronic ‘Breakthrough’ with Aortic Aneurysm Stent
- URL: https://www.fdaweb.com/medtronic-breakthrough-with-aortic-aneurysm-stent/
- Published: 2019-10-09T12:00:00.000Z
- Updated: 2026-09-15T01:55:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145208

FDA has granted Medtronic a breakthrough device designation for its Valiant TAAA Stent Graft System for repairing thoracoabdominal aortic aneurysms (TAAA). The condition causes a bulging of the aorta from the chest down into the abdomen. The investigational device, according to the company, is currently being evaluated in the U.S. within five physician-sponsored investigational device exemption trials.

“TAAA typically involves the branch arteries that supply blood to multiple internal organs and represents about 15% of all thoracic aneurysms,” Medtronic says. “The standard of care is complex open surgery, which is associated with high morbidity and mortality, and 40% of patients are not considered candidates for treatment.”