May 22, 2019

FDA letter updates mortality risk in patients receiving Abiomed Impella RP System

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on May 21 released a letter to healthcare professionals about the most recent, interim post-approval study (PAS) results for the Abiomed Impella RP System, a percutaneous heart pump for right heart support.  

The latest interim results show a lower survival rate for a subgroup of PAS patients who would not have qualified for the premarket clinical studies.

The FDA says when the system is used for the currently approved indication in appropriately selected patients, the benefits continue to outweigh the risks.

The FDA recommends that healthcare providers read and follow the revised labeling, which includes a patient selection checklist to understand which patients may benefit the most from the system.

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