Aortica Corporation today announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study at the University of Washington (UW) sponsored by Principal Investigator & Chief of Vascular Surgery Dr. Benjamin Starnes. The positive decision allows the use of Medtronic’s Valiant NAVION™ stent graft system as a platform for fenestrated endovascular aneurysm repair (FEVAR). Together with Aortica’s AortaFit™ automated case planning software, NAVION will be evaluated for use in the treatment of complex juxtarenal Abdominal Aortic Aneurysms (AAA). NAVION was recently approved by FDA for minimally invasive repair of lesions in the descending thoracic aorta. Dr. Starnes recently reported the successful early results for the AortaFit™ technology in simplifying treatment of patients with highly complex AAA disease.
“I am excited to bring Medtronic’s NAVION into this study,” stated Dr. Starnes. “The device architecture incorporates many of the features we feel are important to simplifying fenestrated EVAR and addressing many of the issues that have limited physician acceptance of FEVAR in the past. 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.”
“Accurately planning these cases using current technology and manual planning is challenging, time consuming and fraught with error,” stated Tom Douthitt, CEO of Aortica Corp. “Consequently, surgeons tend to shy away from Fenestrated EVAR. By automating case planning to provide an accurate graft plan and coupling that with an appropriately designed endograft both the upfront planning and the procedure itself are dramatically simplified, and the endograft becomes ‘personalized’ to the individual patient’s anatomy. We believe this simplified, personalized approach will significantly increase the number of patients who are candidates for less invasive and personalized EVAR.”