Sanford Health Gets FDA Breakthrough Device Designation for Stent Graft

Sanford Health has been granted a Breakthrough Device designation by the FDA for its aortic stent graft system designed to treat thoracoabdominal aortic aneurysms.

The stent graft is inserted in a minimally invasive procedure and opened inside the aorta, allowing blood to flow and preventing the aneurysm from bursting.

The standard of care is complex open surgery, which is associated with a high rate of complications and mortality, and 40 percent of patients are not considered suitable candidates for surgery, the Sioux Falls, S.D.-based company said.