More than a year and a half after securing an approval in Europe, Abbott has gotten the green light from the FDA for the newest generation of its transcatheter aortic valve replacement implant.
The minimally invasive Navitor system was approved this week for people with severe aortic stenosis—or a narrowing of the heart valve, which slows the flow of blood out to the rest of the body—in cases where it would be too risky for them to undergo open-heart surgery.
It’s the second TAVR valve from Abbott to receive the FDA’s blessing since September 2021, when the company’s Portico implant was approved for the same category of patients.
Like the Portico, the Navitor is a self-expanding valve. Both rely on the company’s FlexNav catheter-based delivery system to thread the implant through the blood vessels into the heart and guide its placement.
But by comparison, the Navitor is ringed with a folded-over fabric cuff, designed for a tighter seal to stop blood from flowing backwards and leaking around the edges of the implant, which will ultimately take the place of the heart’s natural aortic valve. The upgraded device can be recaptured and repositioned up until it is fully deployed.
The valve is also designed to allow future surgeons to access the heart’s coronary arteries, by not blocking their inlets near where the left ventricle connects to the aorta.
The FDA’s 2021 approval of the Portico valve marked Abbott’s first entry into the U.S. TAVR market, where it joined longtime competitors Medtronic and Edwards Lifesciences.
The segment had dropped from three down to two players just the year before when Boston Scientific terminated its Lotus Edge TAVR program following a voluntary global recall amid troubles with its delivery system.
“[Navitor] will be our second-generation product. We’ve launched it in Europe and it’s doing incredibly well,” Abbott CEO Robert Ford told investors during the company’s presentation at the J.P. Morgan Healthcare Conference in San Francisco earlier this month. “Given the data we’ve seen and the kind of impact it’s had in the European systems, I truly believe that we have a real shot here at a credible third player in this still very large market.”