September 20, 2021 – Abbott (Abbott Park, IL) announced that the U.S. Food and Drug Administration (FDA) has approved the company’s 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.
Portico is a self-expanding TAVR valve with intra-annular (within the native valve) leaflets that help provide optimal blood flow (hemodynamics) 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, the company says.
The Portico device is implanted using Abbott’s FlexNav delivery system, which features a slim design to accommodate different patient anatomies and small vessels, and optimizes flexibility, ease of tracking and precision of valve placement.