Impella Safety Update: Data Supports Pump For Qualified Patients
Executive Summary
Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.
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FDA Updates Abiomed’s Heart Pump Labeling After Post-Approval Clinical Study
The US Food and Drug Administration recently updated the labeling of Abiomed’s Impella RP System to reflect the latest results from a clinical study on the device. The FDA first approved the heart pump system in September 2017.
FDA Says Abiomed’s Impella RP Pump Works For ‘Appropriate Patients’
In a letter sent 21 May, the US FDA tells physicians the benefits of Abiomed’s Impella RP right-heart circulatory support device outweigh the risks in appropriately selected patients. In February, the agency warned doctors that the postmarket study of the device showed worse survival than the premarket clinical trial.
Abiomed, FDA Attribute High Mortality In Impella RP Post-Market Data To Patient Selection
FDA sent a letter to physicians alerting them to interim results from the post-approval study of Abiomed’s Impella RP right-heart pump system that suggest a higher mortality rate for patients than what was observed in pre-market studies. FDA believes the benefits of the Impella RP system continue to outweigh the risks for patients covered by the currently approved indication; it emphasizes to physicians the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients. The results cited by FDA were announced about two months after results of a non-randomized study in Germany cast doubt on the benefits of Impella for left-sided support in cardiogenic shock patients.