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FDA Approves Study of New Aneurysm Device Developed by Sanford Health

Sanford Vascular Innovations, a division of Sanford Health working on technology to improve vascular surgery and endovascular care, has been approved by the FDA to study a new device to treat complex aneurysms occurring in the descending aorta.

The device, the Unitary Manifold Stent Graft System, was developed by Patrick Kelly, M.D. Kelly is an inventor and vascular surgeon who also developed the concept for the Medtronic Valiant® TAAA Stent Graft System, a minimally invasive and endovascular method to repair thoracoabdominal aortic aneurysms.

The Unitary Manifold Stent Graft System will be studied under an existing physician-sponsored investigational device exemption (PS-IDE - NCT02294435) SVI is using to evaluate the safety of the Valiant device, which uses two off-the-shelf pieces to treat aneurysms. The new technology is also off-the-shelf and debranches thoracoabdominal aortic aneurysms, but it has been reduced to one piece to address shorter, more common versions of the condition.

“The same design features we engineered for the Valiant® device to restore normal blood flow have been applied to the Unitary Manifold Stent Graft System, but we’ve now been able to better match the extent of the aneurysm,” said Kelly. “In appropriate situations, covering shorter areas of the aorta can lessen the chance of paraplegia for patients who have shorter aneurysms.”

An aortic aneurysm is a dangerous bulge or ballooning in a segment of the wall of the aorta that can rupture and cause sudden death if left untreated. Thoracoabdominal aortic aneurysms start in the chest and extend through the abdomen and typically involve the branch arteries that supply blood to multiple internal organs.

Thoracoabdominal aortic aneurysms that exist below the diaphragm and include the renal arteries are classified as type IV, juxtarenal, or pararenal. The Unitary Stent Graft System was designed to repair these shorter, aortic aneurysms. Compared to other types of thoracoabdominal aortic aneurysms, type IVs, juxtarenal, and pararenals are nearly four times as common.

SVI is planning to enroll 15 patients in this arm of the study involving the Unitary Stent Graft System. For more information, visit or call 605-312-7720.

About Sanford Health
Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 43 hospitals and nearly 250 clinics in nine states and four countries. Sanford Health’s 27,000 employees, including 1,400 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children's clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit

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