FDA Advises of Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System
The U.S. Food and Drug Administration (FDA) has issued an update to the February 4, 2019 letter to health care providers to inform the health care community of the most recent, interim post-approval study (PAS) results for Abiomed's Impella RP System. These latest interim results, which are available on the FDA Post-Approval Studies webpage, indicate a lower survival rate for the subgroup of PAS patients who would not have qualified for the premarket clinical studies compared to the premarket clinical study survival rate.
Based on 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.
This update provides a summary of post-approval study assessments and FDA actions to date. It also includes the following recommendations:
The 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.
The FDA continues to recommend that health care providers:
- Be aware that the FDA approval of the Impella RP System was based on the results of premarket clinical studies that included patients who had been in cardiogenic shock for less than 48 hours prior to device implant. Additionally, none of the patients in the premarket clinical studies experienced an in-hospital cardiac arrest, or were treated with an intra-aortic balloon pump, or suffered a hypoxic or ischemic neurologic event, prior to Impella RP being implanted. Although these clinical events may not preclude a clinical decision to use the device, physicians should be aware that the occurrence of one or more of these events prior to Impella RP implantation may decrease expected survival rate.
- Carefully consider these interim survival results from the ongoing PAS when making treatment decisions and discuss the risks and benefits of the Impella RP System with patients and their caregivers. Additionally, be aware that there are currently no other device interventions that have been approved by the FDA under the premarket application (PMA) process for the patient population demonstrating a higher mortality rate in the PAS. As such, other interventions may include their own benefits and risks that should be considered and discussed with patients and their caregivers.
- Report any adverse events or suspected adverse events experienced with the Impella RP System:
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
The FDA will continue to keep the public informed as significant new information or recommendations become available for the Impella RP System.
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