Abbott Enrolls 1st Patient in Navitor TAVI Trial for Low and Intermediate Surgical Risk

Abbott announced that the initial patient was enrolled in its ENVISION investigational device exemption (IDE) trial for its Navitor transcatheter aortic valve implantation (TAVI) system, the latest in its transcatheter structural heart portfolio.
 
The trial will evaluate the Navitor TAVI’s use in about 1,500 low or intermediate surgical risk patients with severe aortic stenosis. Abbott said data from the trial will also be used to support Navitor TAVI’s expanded indication to treating aortic stenosis across those surgical risk categories.
 
The Navitor Vision valve was recently released in the U.S. The valve features radiopaque markers to help surgeons implant the device. Chris Waddell, Abbott’s U.S. VP for TAVI, recently shared in a LinkedIn post that Navitor Vision has stable and precise delivery, excellent hemodynamics and low paravalular leak (PVL) rates.
 
Abbott first announced Navitor TAVI earned U.S. Food and Drug Administration (FDA) approval for high or extreme surgical risk severe aortic stenosis patients in January 2023. Michael Reardon, MD, Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, was the principal investigator for the study that led to FDA approval.
 
Dr. Reardon said that the Navitor TAVI features a design—a NaviSeal fabric cuff—that reduces blood backflow around the heart valve, often a complication after TAVI procedures. “The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies,” he told the press last year.