The company's latest-generation Navitor device has some upgrades to improve patient care, including reducing or eliminating the risk of blood leakage around valve implant


Abbott secures FDA approval for its Navitor TAVI device. (Credit: Abbott)

Abbott has secured approval from US Food and Drug Administration (FDA) for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with aortic stenosis.

The US-based medical device firm has designed Navitor for the treatment of people with severe aortic stenosis who are at high or extreme risk for open-heart surgery.

According to the firm, Navitor has a special fabric cuff (NaviSeal) to lessen or stop the paravalvular leak (PVL), or the backflow of blood around the valve frame.

The device is also the only self-expanding TAVI system with leaflets within the native valve, Abbott claimed. It can aid in facilitating future procedures for treating coronary artery disease by making it easier to reach coronary arteries.

Additionally, the system provides excellent hemodynamics, or blood flow, through the valve.

Abbott’s FlexNav delivery system, which has a narrow design to suit various patient anatomy and small vessels for stable, predictable, and accurate valve delivery and placement, is used to implant the Navitor device.

Abbott structural heart business senior vice president Michael Dale said: “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.

“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.

“Receiving this approval is a major next step in our mission to help people live better lives through better health.”

The Navitor TAVI device is the newest addition to Abbott’s extensive transcatheter structural heart portfolio that provides physicians and patients with less invasive treatment alternatives for heart diseases.

When the opening of the aortic valve narrows, it results in aortic stenosis, which limits blood flow to the body.

The US-based medical device firm said physicians may use minimally invasive surgery employing TAVI therapies like the Navitor system to reduce potential complications resulting from age, fragility, or several other diseases or ailments.