FDA Approves Use of Medtronic's Valiant Navion in Study of Aortica's Case-Planning Technology
December 17, 2018—Aortica Corporation announced that the FDA has approved a supplement to an ongoing physician-sponsored investigational device exemption study at the University of Washington. The study is sponsored by Principal Investigator Benjamin Starnes, MD, who is Chief of Vascular Surgery at University of Washington. The approval allows the use of the Valiant Navion stent graft system (Medtronic) as a platform for fenestrated endovascular aneurysm repair (FEVAR).
With Aortica’s AortaFit automated case planning software, the Navion device will be evaluated for use in the treatment of complex juxtarenal abdominal aortic aneurysms (AAAs). Dr. Starnes recently reported the successful early results for the AortaFit technology in simplifying the treatment of patients with highly complex AAA disease.
The Navion device was recently approved by the FDA for minimally invasive repair of lesions in the descending thoracic aorta.
In Aortica's announcement, Dr. Starnes commented, “I am excited to bring Medtronic’s Navion into this study. The device architecture incorporates many of the features we feel are important to simplifying FEVAR and addressing many of the issues that have limited physician acceptance of FEVAR in the past.”
Dr. Starnes continued, “In conjunction with Aortica’s automated graft planning technology, the Navion provides a combination of mechanical strength with ample available fabric area for placement of fenestrations. I am optimistic about the possibilities created by bringing these two technologies together.”