FDA Updates Abiomed’s Heart Pump Labeling After Post-Approval Clinical Study
Executive Summary
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...
Impella Safety Update: Data Supports Pump For Qualified Patients
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.
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.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.