First Patient Treated in Study of Medtronic Valiant TAAA Stent Graft System
February 9, 2016—Medtronic plc and Sanford Health, one of the nation’s largest health care systems, announced the first patient enrolled in a clinical study using the Medtronic Valiant thoracoabdominal aortic aneurysm (TAAA) stent graft system. The Valiant TAAA device is intended to allow for an off-the-shelf endovascular solution to one of surgery's most difficult pathologies.
Patrick Kelly, MD, the inventor of the device and the leader of Sanford Vascular Innovations, performed the procedure. The procedure was conducted as part of a physician-sponsored investigational device exemption trial, “Visceral Manifold Study for the Repair of TAAA," approved by the US Food and Drug Administration. Sanford Health, based in Sioux Falls, South Dakota, announced plans for the study in February 2015.
Dr. Kelly developed the concept for the system and collaborated with Medtronic to create the device. Sanford Health holds the intellectual property covered by the exclusive patent license agreement with Medtronic. Medtronic plans to study the system in collaboration with physicians at several medical centers, including Dr. Kelly at Sanford Health.
Dr. Kelly reported that the patient was a 58-year-old woman with few alternative medical options for treatment of her aneurysm. In the announcement, he commented, “The mortality rate is 25% when treating a TAAA with an open surgical technique, which involves cutting open the aorta. Providing the patient with an option for a less-invasive approach is needed.”
Dr. Kelly continued, “This procedure marked an important step in the process to obtain FDA approval, and Sanford’s support of such innovation will give hope to patients afflicted with challenging disease states such as this.”
Also in the Medtronic and Sanford press release, James Black III, MD, Chief of the Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins Hospital in Baltimore, Maryland, commented, “The Valiant TAAA approach allows for the procedure to be staged at any time and lets the operator work on each branch vessel individually. When taking on challenging cases, the device leverages skill sets that are quite routine for vascular surgeons.”
Thomas Naslund, MD, Chief of the Division of Vascular Surgery at Vanderbilt University Medical Center in Nashville, Tennessee, added, “The novel device is customizable and diverse. It’s critical that our field focus on innovative ways to treat these kinds of aneurysms.”