Abbott’s new self-expanding TAVR system gains CE mark approval
Abbott announced May 17 that the company has gained CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system. As a result, TAVR with the self-expanding Navitor system is now available to high-risk patients with severe aortic stenosis in Europe.
Navitor was designed using Abbott’s FlexNav delivery system and the company’s NaviSeal technology for reducing the risk of a paravalvular leak.
“The innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVR procedures for physicians, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives,” Michael Dale, senior vice president of Abbott's structural heart business, said in a prepared statement. “This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.”
“With an aging world population and with aortic stenosis cases projected to double in Europe and the U.S. in the next few decades, the need for innovative, minimally invasive solutions is critical,” added Lars Sondergaard, MD, a cardiologist at Copenhagen University Hospital in Denmark. “While transcatheter valve replacement has for some time been a standard of care for patients with a narrowing of the aortic valve, Navitor helps to address challenges we sometimes find in current TAVR systems when we encounter complex patient anatomies that can lead to potential complications.”
The Navitor TAVR system and FlexNav delivery system are both approved for investigational use only in the United States.
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