US FDA approves study of Sanford Health Unitary Manifold stent graft system

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Sanford Vascular Interventions Unitary manifold stent graft system
Sanford Vascular Interventions Unitary manifold stent graft system

Sanford Vascular Innovations, a division of Sanford Health, has receive US Food and Drug Administration approval to study the Unitary Manifold stent graft system device to treat complex aneurysms occurring in the descending aorta.

Patrick Kelly
Patrick Kelly

The device was developed by Patrick Kelly, 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, according to a company release.

The Unitary Manifold stent graft system will be studied under an existing physician-sponsored investigational device exemption (PS-IDE – NCT02294435) which the company 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.

“We are excited to be studying a new stent graft system for treating complex aneurysms,” Kelly says.  “This new system can be used for treating juxtarenal, pararenal and type IV TAAAs.”