Abbott (NYSE:ABT) today announced U.S. FDA approval of its Portico with FlexNav TAVR system.
The approval launches Abbott into a U.S. TAVR space that Edwards Lifesciences and Medtronic have dominated. (Check out our recent DeviceTalks Weekly podcast that recounted Edwards Lifesciences’ pioneering work in the space.) Boston Scientific is out of the TAVR market for now after the retirement of its Lotus program in late 2020.
Abbott officials think they’ll have an edge through the comprehensive nature of their structural heart portfolio.
“With the approval of our TAVR therapy in the U.S., physicians now have access to an even more robust set of solutions to treat structural heart disease,” said Michael Dale, SVP of Abbott’s structural heart business.
“This latest and important introduction of Portico with FlexNav represents another milestone in our work to advance our mission to restore health and improve quality of life so more people can get back to living fuller lives,” Dale said in a news release.
For now, the FDA’s approval of Portico with FlexNav covers people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.
Abbott’s Portico is a self-expanding TAVR valve with intra-annular (within the native valve) leaflets. The Portico’s creators designed its structure to help provide optimal blood flow (hemodynamics) when placed inside a patient’s natural valve.
The Portico’s structure also preserves access to the critical coronary arteries for future interventions.
The FlexNav delivery system that delivers the Portico features a slim design to accommodate different patient anatomies and small vessels. The idea is to optimize flexibility, ease of tracking and precision of valve placement.