FDA Approves Abbott’s Portico Heart Valve

Abbott has received the FDA’s approval for its Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

Before TAVR became available, the standard of care for severe aortic stenosis was surgical aortic valve replacement, but not all patients were candidates for open-heart surgery.

Portico is a self-expanding TAVR valve with leaflets that help provide optimal blood flow when placed inside a patient’s natural valve. The structure of the replacement valve also preserves access to the critical coronary arteries for future coronary interventions, Abbott says.