FDA Update: Abbott Portico With FlexNav TAVR System Approved For AS Patients

The U.S. Food and Drug Administration on Sept. 20 approved the Abbott Portico with the FlexNav TAVR system to treat patients with symptomatic, severe aortic stenosis (AS) at high or extreme risk for open heart surgery.

Portico is a self-expanding TAVR valve with intra-annular leaflets that help provide optimal blood flow when placed in a patient’s natural valve. The structure of the replacement valve preserves access to the coronary arteries for future coronary interventions. The Portico valve is implanted with Abbott’s FlexNav delivery system, which is designed to accommodate different anatomies and small vessels, and optimizes flexibility, ease of tracking and precise placement.

Read the full press release from Abbott or the FDA’s approval order.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: ACC Advocacy, Aortic Valve, Hemodynamics, Aortic Valve Stenosis, United States Food and Drug Administration, Coronary Vessels, Transcatheter Aortic Valve Replacement

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