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September 21, 2021

FDA approves Abbott’s transcatheter aortic valve replacement system

The system is indicated for severe aortic stenosis patients with high or extreme risk for open-heart surgery.

The US Food and Drug Administration (FDA) has approved Abbott’s Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat individuals with symptomatic, severe aortic stenosis.

The system is intended for use in patients who are at high or extreme risk for open-heart surgery.

A self-expanding TAVR valve with intra-annular leaflets within the native valve, Portico could aid in providing streamlined blood flow or haemodynamics when placed inside a patient’s natural valve.

Furthermore, the replacement valve’s structure maintains access to the vital coronary arteries for potential future interventions.

Positioned using Abbott’s FlexNav delivery system, the Portico device has a slim design to fit varying patient anatomies as well as small vessels.

In addition, the device improves flexibility, ease of tracking and accuracy of valve placement.

With the development of the new TAVR system, also known as transcatheter aortic valve implantation (TAVI), Abbott continues to provide the industry’s leading portfolio of structural heart solutions.

These solutions include minimally invasive treatments to close openings in the heart as well as repair or replace diseased or damaged heart valves.

Abbott structural heart business senior vice-president Michael Dale said: “With the approval of our TAVR therapy in the US, 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.”

An especially common and life-threatening heart valve disease, aortic stenosis happens when the opening of the aortic valve shrinks and hinders blood flow from the left ventricle to the aorta.

Last month, Abbott reported data from the GUIDE-HF clinical trial, where its CardioMEMS HF System reduced mortality in New York Heart Association Class II, III and IV heart failure patients.

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