Harvard Heart Letter

FDA approves another device to replace aortic valve without surgery

When the heart's aortic valve stiffens or becomes clogged with calcium deposits, the condition—known as aortic valve stenosis—can lead to fainting and chest pain. Some people can't tolerate open-heart surgery to replace the valve. But a less invasive procedure, called transcatheter aortic valve replacement, or TAVR, is another option.

In July, the FDA approved a new device called the CoreValve System for this purpose. The valve is made from pig tissue attached to a flexible, nickel-titanium frame. A catheter carrying the CoreValve is threaded through the artery at the top of the thigh up to the opening between the heart and the aorta. Once it reaches the diseased aortic valve, the device expands and anchors to the old valve. Then the replacement valve takes over, helping blood flow freely from the heart to the rest of the body. A similar device, called the Sapien Transcatheter Heart Valve, was approved in 2011.

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