Impella RP survival only 17% so far (not 73%), says FDA
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The FDA is advising physicians that in post-approval data, 30-day survival rates with Abiomed's Impella RP right ventricular assist device have been only 17%, compared to 73% in the RECOVER RIGHT study leading to the device's approval in 2017. There were only 60 patients in the post-approval study, who had significantly worse clinical status at baseline compared to the originally studied patients:
Impella RP survival only 17% so far (not 73%), says FDA
Impella RP survival only 17% so far (not…
Impella RP survival only 17% so far (not 73%), says FDA
The FDA is advising physicians that in post-approval data, 30-day survival rates with Abiomed's Impella RP right ventricular assist device have been only 17%, compared to 73% in the RECOVER RIGHT study leading to the device's approval in 2017. There were only 60 patients in the post-approval study, who had significantly worse clinical status at baseline compared to the originally studied patients: