FDA approves study of new aneurysm device developed by Sanford Health

BY KAYLA PRASEK

The Food and Drug Administration has approved Sanford Vascular Innovations to study a new device to treat complex aneurysms occurring in the descending aorta, part of the largest artery in the body. SVI is a division of Sanford Health working on technology to improve vascular surgery and endovascular care.

The device, the Unitary Manifold Stent Graft System, was developed by Dr. Patrick Kelly, a 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 was designed to repair shorter aortic aneurysms that exist below the diaphragm, including renal arteries.

“We really needed a stent graph to specifically treat these patients,” Kelly says. “It has the same design concept but covers less aorta.”

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.

Kelly says the FDA usually approves devices and medicines in stages, so at this point the Unitary Manifold Stent Graft System has only been approved to be used in a clinical study. SVI plans to enroll 15 patients in its clinical study.

Patrick Kelly

“We’re hopeful this stage will take only a year, but it depends on how quickly we can get patients enrolled and how they do in the study,” Kelly says. In order to move on to the next stage, Kelly and his team must gather data on each patient to prove the device’s effectiveness. PB

Kayla Prasek Staff Writer, Prairie Business 701.780.1187