Abbott’s Navitor for Severe Aortic Stenosis Receives CE Mark

Abbott recently announced that it received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, for individuals with severe aortic stenosis in Europe.

Navitor is a minimally invasive device that is available to individuals with aortic stenosis who are at high or extreme surgical risk. The system advances TAVI therapies with innovations, such as a unique design to prevent blood leaking around the valve.

Abbott’s FlexNav delivery system received CE Mark in 2020. This device offers a slim design with the lowest TAVI delivery system profile, allowing treatment of individuals with vessels as small as 5.0 millimeters.

The design can accommodate different aortic anatomies for stable, predictable, and accurate valve delivery and placement, an Abbott spokesperson explained.

Using FlexNav, the Navitor TAVI system is the latest addition to the company’s structural heart transcatheter portfolio that gives physicians and patients less invasive options to treat heart disease.

"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," Lars Søndergaard, MD, professor of cardiology at Copenhagen University Hospital in Denmark and co-principal investigator for the global Navitor TAVI system clinical study.

"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 TAVI systems when we encounter complex patient anatomies that can lead to potential complications,” Søndergaard continued.

Navitor features a fabric cuff that works with the cardiac cycle to reduce or eliminate a backflow of blood around the valve frame known as paravalvular leak (PVL). This a common complication following TAVI procedures.

Currently, the device is the only self-expanding TAVI system with intra-annular leaflets and large frame cells, an Abbott spokesperson explained. These features help to improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease.

Additionally, the new design provides improved hemodynamics, or improved blood flow.

Aortic stenosis occurs when the heart's aortic valve narrows, and the valve doesn't open fully. This reduces or blocks blood flow from the heart, into the main artery, and throughout the body.

Generally, aortic valve replacement (AVR) therapy is a front-running choice in severe aortic stenosis patients because it improves symptoms, left ventricle function, and overall survival. But this surgery is considered a high-risk procedure due to potential complications with age, frailty, or having multiple other diseases or conditions.

Abbott’s TAVI is a less-invasive alternative to surgical aortic valve replacement and can reduce symptoms and improve the lives of patients with this condition.

Currently, the Navitor TAVI and FlexNav Delivery System are approved for investigational use only in the US, an Abbott spokesperson said.

"The innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives," said Michael Dale, senior vice president of Abbott's structural heart business.

"This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition,” Dale continued.

Notably, there is no pill that can cure or improve aortic stenosis, but there are some medications that may help control symptoms and lower the chance of having certain complications.

These treatments include ACE inhibitors, which can open blood vessels more fully, medicines that tame heart rhythm problems, beta-blockers, and Diuretics, which lessen the amount of fluid in an individual’s body and ease stress on the heart.