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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:
Specifically, before being implanted with the Impella RP system, patients in the post-approval study were more likely than patients in the premarket studies to have been in shock for longer than 48 hours, experienced an in-hospital cardiac arrest, had an intra-aortic balloon pump, or had a stroke or lack of blood flow to the brain ... The FDA believes that when the device is used for the approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks," according to the letter.
Translation: "early-adopter" physicians are primarily using the device as a salvage therapy in the most severely ill patients, as compared to the trial population, who were carefully selected by the investigators.
Impella RP is FDA approved for use in right heart failure refractory to medical treatment, with suggested uses by its manufacturer including myocardial infarction with shock, heart transplant, or open heart surgery. RECOVER RIGHT included 30 patients with shock after left ventricular device implantation, after cardiotomy or myocardial infarction. The device was not studied in, nor is it approved for use in patients with right heart failure due to pulmonary embolism.