FDA Grants Breakthrough Device Designation to Medtronic’s Minimally Invasive Valiant TAAA Stent Graft System


The new Valiant TAAA Stent Graft System is designed to repair a thoracoabdominal aortic aneurysm (TAAA). A TAAA causes swelling of the aorta, which extends from the chest into the abdomen. Commonly, TAAA affects the branch arteries supplying blood to various internal organs. The condition accounts for approximately 15% of all thoracic aneurysms. The standard of care for TAAA is open surgery, which is complex and known to cause high morbidity and mortality. 40% of patients are not considered eligible for treatment, added Medtronic. Medtronic’s stent is intended to provide an off-the-shelf endovascular solution for treating the condition. Currently, the device is undergoing five investigational device exemption trials in the US.


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