Abbott’s Portico Device Receives FDA Approval
A new transcatheter aortic valve replacement (TAVR) device, Abbott’s Portico, has been approved by the FDA to treat patients who have asymptomatic severe aortic stenosis.
The system is designed to be used with patients who are at increased or severe risk for open-heart surgery.
Portico consists of a self-expanding TAVR valve containing intra-annular leaflets inside the native valve.
The Portico system is designed to aid in facilitating haemodynamics (streamlined blood flow) when inserted into the patient’s natural valve.
Furthermore, the replacement valve’s structure allows future interventions to be conducted via coronary arteries without preventing access to the vital arteries.
The Portico device uses Abbott’s FlexNav system to deliver medicine to patients with varying anatomies, or patients with small vessels.
The device is also flexible, easy to track, and improves valve placement accuracy.
As a result of its new TAVR medical system, also known as transcatheter aortic valve implantation (TAVI), Abbott maintains its leadership status as the leading manufacturer of structural heart solutions in the industry.
In addition to repairing and replacing diseased or damaged heart valves, minimally invasive solutions are now available to close openings in the chambers of the heart.
Patients with severe aortic stenosis used to need surgical aortic valve replacement before TAVR was available, but not every patient was an open-heart surgery candidate.
Heart valve disease caused by aortic stenosis is a leading cause of death. This disease is caused by narrowing of the aortic valve and restricting the flow of blood from the left ventricle into the aorta.
Patients with this disease may experience symptoms such as breathlessness, pressure or tightness in the chest, fainting, heart palpitations, exhaustion and cardiac murmurs.
Michael Dale, the senior vice president of the structural heart segment of Abbott’s Business, 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.”
© Abbott Laboratories
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