Aortica Corp. Announces FDA Approves Medtronic Valiant NAVION™ for Inclusion in Starnes’ Physician-Sponsored IDE
BELLEVUE, Wash.--(BUSINESS WIRE)--Dec 17, 2018--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.”
About Abdominal Aortic Aneurysm (AAA) Disease, EVAR & FEVAR
In 2017, nearly 550,000 people worldwide were diagnosed with abdominal aortic aneurysms (AAA), and 200,000 of these required some form of repair. EVAR is a significantly less invasive option to open surgery and is associated with a mortality rate six times lower. Patients recover faster, leave the hospital sooner, and return to activities of normal daily life more quickly. Consequently, EVAR has become the gold standard for treatment of AAA disease. Unfortunately, 40% of patients requiring repair (85,000) have aortic anatomy structured in a manner that does not allow an endograft to be deployed safely without blocking blood flow to vital organs. FEVAR is the preferred treatment option for these patients. FEVAR involves placing reinforced, radiopaque holes (or fenestrations) in the endograft that align with branch arteries. This allows the physician to place the graft higher up in the aortic anatomy allowing for reliable anchoring and secure seal, while preserving blood flow to vital organs. Today only 6% of candidate patients receive FEVAR due to the complexity of current FEVAR technology. Simplification of the procedure will result in significantly more patients becoming candidates for FEVAR therapy.
About Aortica Corporation
Aortica Corporation was founded to design, manufacture, and market tools for treatment of patients with juxtarenal AAA disease. Aortica is dedicated to simplifying Fenestrated EVAR (FEVAR) and advancing the science of Personalized Vascular Therapy.
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CONTACT: Aortica Corporation
KEYWORD: UNITED STATES NORTH AMERICA WASHINGTON
INDUSTRY KEYWORD: SURGERY TECHNOLOGY SOFTWARE HEALTH CARDIOLOGY CLINICAL TRIALS MEDICAL DEVICES FDA
SOURCE: Aortica Corporation
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PUB: 12/17/2018 05:00 AM/DISC: 12/17/2018 05:01 AM