Portico, which is implanted using FlexNav TAVR system, is indicated for the treatment of people with symptomatic and severe aortic stenosis who are at high or extreme risk for open-heart surgery
The FDA has approved Abbott’s Portico with FlexNav TAVR system. (Credit: Abbott)
Abbott has secured approval from the US Food and Drug Administration (FDA) for its Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat aortic valve disease.
The Portico with FlexNav TAVR system is indicated for the treatment of people with symptomatic and severe aortic stenosis who are at high or extreme risk for open-heart surgery.
With the latest TAVR solution, the company is now offering an advanced portfolio of structural heart solutions that consist of minimally invasive therapies to repair or replace diseased or damaged heart valves or close openings in the heart.
Aortic stenosis, which is a common and life-threatening heart valve disease, results when the aortic valve’s opening narrows and restricts blood flow from the left ventricle to the aorta.
Portico is a self-expanding TAVR valve with intra-annular (within the native valve) leaflets, which enable to deliver optimal blood flow (hemodynamics) when placed inside a patient’s natural valve.
The structure of the replacement valve also allows to provide access to the critical coronary arteries for future coronary interventions.
Abbott’s FlexNav delivery system is used to implant the Portico device. The FlexNav system features a slim design to accommodate different patient anatomies and small vessels, as well as enhance flexibility, ease of tracking and precision of valve placement.
Abbott’s structural heart business senior vice president Michael Dale said: “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.
“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.”
In August this year, Abbott secured FDA approval for its Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke.