Aortica touts FDA clearance to use Medtronic’s Valiant Navion in AAA IDE study

December 17, 2018 By Fink Densford Leave a Comment

Aortica said today that the FDA approved the use of Medtronic‘s (NYSE:MDT) Valiant Navion stent graft system alongside Aortica’s AortaFit in a physician sponsored IDE study.

The study, being run by principal investigator Dr. Benjamin Starnes at the University of Washington, will now use the Valiant Navion as a platform for fenestrated endovascular repair together with the AortaFit automated case planning software.

“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 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,” Dr. Starnes said in a prepared statement.

The Navion device will be evaluated for its use in the treatment of complex juxtarenal abdominal aortic aneurysms, the Bellevue, Wash.-based company said. Aortica said that investigators in the study recently released early results for the AortaFit system designed to simplify AAA treatment.

“Accurately planning these cases using current technology and manual planning is challenging, time consuming and fraught with error. 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,” Aortica CEO Tom Douthitt said in a press release.

Last June, Aortica said that it raised $1 million in a round of mixed financing.

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