Devices

Update Safety Alert on Abiomed's Impella RP System

A revised safety update on Abiomed's Impella RP System emphasizes proper patient selection after interim post-approval study (PAS) results indicated a lower survival rate for the subgroup of PAS patients who would not have qualified for inclusion in clinical studies performed before the device was approved. The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery. “Based on our current analysis, the FDA believes that when the device is used for the currently approved indication in appropriately selected patients the benefits of the Impella RP system continue to outweigh the risks,” the update says.

“Interim results from the most recent Impella RP System PAS report indicate that 12 out of the 42 enrolled PAS patients (28.6%) survived to 30 days post device explant or hospital discharge, or to the start of next longer term therapy,” the agency says. “In the premarket clinical studies, the survival rate was 73.3%.”

The primary reason for different survival outcome appears to be patient selection, FDA says. “For the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies, the survival rate was 64.3% (9 out of 14 patients) which is similar to the premarket clinical study survival rate,” it says. “For the subgroup of PAS patients who would not have qualified for the premarket clinical studies, the survival rate was 10.7% (3 out of 28 patients). In these patients, the PAS survival rate should be interpreted in the context of the patients' conditions and limited treatment options.”

FDA recommends that health care providers read and follow the revised labeling for Abiomed’s Impella RP System, which includes a patient selection checklist to understand which patients may benefit the most from treatment with the Impella RP System.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome