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Recent Device Approvals: Sorin Freedom SOLO Stentless Heart Valve and SOLO Smart Stentless Heart Valve

The FDA has recently approved the Sorin Freedom SOLO Stentless Heart Valve and SOLO Smart Stentless Heart Valve to be marketed.  The Freedom SOLO Stentless Heart Valve is an artificial aortic valve that is intended 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 SOLO Stentless Heart Valve except that it contains a flexible holder that helps the surgeon sew the valve in place.  For more information, please see: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm406443.htm


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