FDA Updates Safety Event Data for Impella RP SystemMay 23, 2019
The Food and Drug Administration (FDA) has issued an updated letter to healthcare providers regarding interim post-approval study (PAS) data for the Impella RP System (Abiomed). The most recent, interim PAS results demonstrated a lower 30-day survival rate for a subgroup of PAS patients who have not qualified for the premarket clinical studies compared with survival rates reported in the premarket clinical trial (28.6% versus 73.3%, respectively).
According to the FDA, patient selection was the source for the difference in survival rates. In April 2019, the FDA approved revised labeling to include additional information on patient selection and which patients may benefit most from the use of this device. Based on the current analysis, the FDA notes that the benefits of using the Impella RP System for the currently approved indication in appropriately selected patients outweighs the risks.
The FDA recommends that healthcare providers promptly report adverse events or suspected adverse events experienced with the Impella RP System. The FDA will continue to work with Abiomed to monitor survival rates.
The Impella RP System is a minimally invasive, miniaturized percutaneous circulatory support system indicated to restore normal right heart hemodynamics, reduce RV work, and allow the right heart time to potentially recover adequate contractile function or to be bridged to the next therapy.
Food and Drug Administration. Update: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System – Letter to Health Care Providers. March 21, 2019. Available at: click here. Accessed May 23, 2019.