FDA Approves Study of New Aneurysm Device Developed by Sanford Health

June 21, 2016

Unitary Manifold Stent Graft System designed by Dr. Patrick Kelly

SIOUX FALLS, S.D. – 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 for minimally invasive repair of thoracoabdominal aortic aneurysm.

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 TAAA Stent Graft System. The unitary technology is off-the-shelf and debranches thoracoabdominal aortic aneurysms with one piece to address shorter, more common versions of the condition.

“Sanford Vascular Innovations is committed to providing more options for patients, and we are excited to be studying a new stent graft system for treating complex aneurysms,” Kelly said.  “This new system can be used for treating juxtarenal, pararenal and type IV TAAAs.”

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 Manifold 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 Manifold Stent Graft System. For more information, visit sanfordvascularinnovations.org 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 sanfordhealth.org.

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