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.
You may also be interested in...
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.
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.
The US Food and Drug Administration has designated a recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps from Datascope/Getinge as class I due to the potential for the pumps to shut down during use.