FDA: Post-Approval Study Finds High Mortality Rate Among Heart Pump Patients

(February 6, 2019, 9:53 AM EST) -- SILVER SPRING, Md. — The Food and Drug Administration on Feb. 5 said it is evaluating interim post-approval study (PAS) results that show that only four out of 23 patients implanted with the Impella RP System heart pump survived....

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