UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling – Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued an updated Letter to Health Care Providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed.
The final PAS results show the survival rate for the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies is consistent with the premarket clinical studies survival rate and further confirms that the device is safe and effective when used for its currently approved indication. The FDA approved updated labeling for the Impella RP System, based on the PAS results, with an updated indications for use statement to better reflect the characteristics of the patients who may benefit the most from treatment with the device.

The Letter to Health Care Providers includes important information about the Impella RP system including:

• Details on the post-approval study (PAS) results, including the survival rate in the PAS, and the related updated labeling.
• Recommendations for health care providers.
• Background information about the issue.
• Instructions for reporting problems with the Impella RP System.

Questions?

If you have questions about the Impella RP system, contact the Division of Industry and Consumer Education (DICE).