FDA Approves Abbott’s Navitor TAVI System for Aortic Stenosis

The FDA has approved Abbott’s latest-generation transcatheter aortic valve implantation (TAVI) system Navitor for the treatment of individuals with severe aortic stenosis who are at extreme or high risk for open-heart surgery.

“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.”

The new TAVI system is a less invasive treatment options for patients and physicians for common and serious heart diseases.

Aortic stenosis is when the aortic valve’s opening narrows and restricts blood flow. If untreated, it can cause heart failure and death. Physicians could decide to use TAVI therapies, including the Navitor system, for individuals with severe aortic stenosis who are at extreme or high surgical risk, because of potential complications related to age, frailty, or other diseases or 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 has a fabric cuff to eliminate or reduce the backflow of blood to the valve frame, which is known as paravalvular leak.

It is also the only self-expanding TAVI system with leaflets within the native valves, which helps improve access to coronary arteries and help future procedures for treating coronary artery disease, according to a statement from the company.

Additionally, the system provides good hemodynamics, known as blood flow, through the valve.

The Navitor device is implanted with the company’s FlexNav delivery system, which has a slim design used to accommodate different patient anatomies and small vessels for accurate, predictive, and stable valve delivery and placement.

Reference

Abbott receives FDA approval for Navitor, a next generation TAVI system designed to treat aortic stenosis. Abbott. News release. January 17, 2023. Accessed January 19, 2023. https://abbott.mediaroom.com/2023-01-17-Abbott-Receives-FDA-Approval-for-Navitor-TM-,-a-Next-Generation-TAVI-System-Designed-to-Treat-Aortic-Stenosis