Edwards Lifesciences Corp. shares rose 2.0% in afternoon trade Thursday after the company's Sapien XT and Sapien 3 transcatheter heart valves were expanded for use in intermediate risk patients by the Food and Drug Administration. The two heart valves had previously only been approved for patients at high or greater risk for death or surgical complications. Patients who need aortic valve replacement but were only intermediate risk typically undergo open-heart surgery, which is far more invasive than a transcatheter heart valve, according to the FDA. The two valves have serious side effects, including death, stroke and heart attack, the FDA said. Edwards will have to conduct a study following the valves' approval to follow patients from clinical trials for the next decade and monitor safety and effectiveness. Edwards Lifesciences shares rose 15.0% over the last three months, compared with a 6.7% rise in the S&P 500 .
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