CryoLife's (Kennesaw, Georgia) decellularized replacement heart valve used to replace diseased, damaged, malformed or malfunctioning pulmonary valves in early February received FDA 510(k) clearance. Children who face multiple surgeries for congenital heart defects will likely be the most significant beneficiaries of the new valves, according to the company, by potentially reducing the number of surgeries they must have over a lifetime.
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