On May 21, the U.S. Food and Drug Administration (FDA) released a letter to health care professionals about the most recent, interim post-approval study results for the Abiomed Impella RP System. Results show that there is a "lower survival rate for the subgroup of post-approval study patients who would not have qualified for the premarket clinical studies compared to the premarket clinical study survival rate."

According to the FDA, when the device is used for the currently approved indication in appropriately selected patients, the benefits continue to outweigh the risks. However, the FDA recommends that health care providers read and follow the revised labeling, which includes a patient selection checklist to understand which patients may benefit the most from treatment with the Impella RP System.

The FDA also encourage health care professionals to report any adverse events or suspected adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Read more on the FDA's website.

Keywords: ACC Advocacy, United States Food and Drug Administration, Survival Rate, Patient Selection, Product Labeling, Risk, Health Personnel

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