FDA Approves Study of New Unitary Manifold Stent Graft System for TAAA

June 21, 2016—Sanford Vascular Innovations (SVI), a division of Sanford Health, announced US Food and Drug Administration approval to study a new device to treat complex aneurysms occurring in the descending aorta. Sanford Health is an integrated health system headquartered in the Fargo, North Dakota and Sioux Falls, South Dakota regions.

The device is the Unitary Manifold stent graft system, which was developed by Patrick Kelly, MD. Dr. Kelly, an inventor and vascular surgeon, also developed the concept for the endovascular Medtronic Valiant thoracoabdominal aortic aneurysm (TAAA) stent graft system.

The Unitary Manifold stent graft system, which was designed to repair TAAA, will be studied under an existing physician-sponsored investigational device exemption trial that SVI is using to evaluate the safety of the Valiant device. SVI is planning to enroll 15 patients in this arm of the study involving the Unitary Manifold device.

The company noted that the Valiant device uses two off-the-shelf pieces to treat aneurysms. The Unitary Manifold technology is also off-the-shelf and debranches TAAAs, but it has been reduced to one piece to address shorter, more common versions of the condition.

In the company’s announcement, Dr. Kelly commented, “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. In appropriate situations, covering shorter areas of the aorta can lessen the chance of paraplegia for patients who have shorter aneurysms.”