Technology | October 23, 2014

FDA Clears Pair of Stentless Heart Valves from Sorin

Both models designed to replace a diseased, damaged or malfunctioning aortic heart valve

October 23, 2014 — The U.S. Food and Drug Administration (FDA) approved the Freedom Solo and Solo Smart stentless heart valves from Sorin Group Canada Inc. to replace a diseased, damaged or malfunctioning aortic heart valve.

The valve is made from natural tissue obtained from the sac that surrounds the heart of a cow. It is called stentless because the frame does not contain any metals or polymers. The Solo Smart stentless heart valve is identical to the Freedom stentless heart valve except that it contains a flexible holder that helps the surgeon sew the valve in place.

The Freedom Solo stentless heart valve replaces an aortic valve that does not properly close all the way so that blood leaks back into the heart, or does not open fully, so that blood flow through it is reduced. Either condition can result in serious health problems. The artificial valve is implanted by first placing the patient on a cardiopulmonary bypass machine, which takes over the task of breathing for the patient and pumping their blood throughout their body. Once on bypass, the surgeon then removes the existing aortic valve and sews the new one into place.

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