FDA approves Valiant NAVION for inclusion in physician-sponsored IDE

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Valiant Navion

The Valiant NAVION stent graft system (Medtronic) has been approved by the US Food and Drug Administration (FDA) for inclusion in a physician-sponsored investigational device exemption (IDE) study. 

The physician-sponsored IDE study is currently ongoing at the University of Washington (UW; Seattle, USA) sponsored by the principal investigator and chief of Vascular Surgery, Benjamin Starnes. The FDA decision will allow the use of Medtronic’s Valiant NAVION stent graft system as a platform for fenestrated endovascular aneurysm repair (FEVAR). Together with the AortaFit (Aortica) 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 and also given CE mark for minimally invasive repair of lesions in the descending thoracic aorta. 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 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. “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 ‘personalised’ to the individual patient’s anatomy. We believe this simplified, personalised approach will significantly increase the number of patients who are candidates for less invasive and personalised EVAR.”

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