Abbot’s Navitor TAVI System Cleared by FDA
Medical device company Abbott’s latest generation TAVI (transcatheter aortic valve implantation) system Navitor, which is used for the treatment of those suffering from severe aortic stenosis, and who are at extreme or very high risk for open heart surgery, has recently been approved by the FDA.
“Abbott’s Navitor device features advancements to help doctors safely and effectively treat patients with aortic stenosis, including a design that reduces the backflow of blood around the valve that’s often a complication following TAVI procedures,” Michael Reardon, MD, the Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, said in a statement.
“The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies.” This new TAVI system provides a less invasive treatment option for common and serious heart diseases for both patients and physicians.
Aortic stenosis takes place when the opening of the aortic valve narrows, restricting blood flow, and without treatment, can lead to heart failure, then death. Clinicians could choose to use TAVI therapies, which include the Navitor system, on individuals who are at high risk of surgery, due to complications which could relate to frailty, age, or other medical conditions. “Our Navitor valve builds upon our industry-leading portfolio of minimally invasive devices that surpass existing standards of care to address a range of heart diseases, Michael Dale, senior vice president of structural heart business at Abbott, said in the statement.
“Navitor is the first TAVI system to offer optimal hemodynamics in all valve sizes, while also preserving options for lifetime disease management, an important consideration for physicians and patients when selecting a TAVI solution,” he said.
“Receiving this approval is a major next step in our mission to help people live better lives through better health.” The Navitor system is equipped with a fabric cuff, to reduce or eliminate blood backflow to the valve frame, known as a paravalvular leak.
The Navitor is also the only TAVI system which self-expands containing leaflets within the native valves. This helps to improve access to coronary arteries, and helps future procedures designed for treating coronary artery disease, the company said in a statement. The system has also been applauded for its good hemodynamics (blood flow) through the valve. The FlexNav delivery system is implanted in the Navitor device, and its slim design is used to accommodate various patient anatomies, as well as small vessels for predictive, stable and accurate valve delivery and placement.
© Abbott Laboratories