FDA Warns of Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System
In a letter to health care providers, the U.S. Food and Drug Administration (FDA) is reporting that their evaluation of recent interim post-approval study (PAS) results suggest a higher mortality rate for patients treated with the Abiomed Impella RP System than the rate previously observed in the premarket clinical studies. The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery. The FDA wants to ensure provides are aware of the mortality rate that has been observed in the ongoing PAS.
Although the FDA is concerned about the high mortality rate from the interim PAS results, the agency 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 FDA has the following recommendations for health care providers:
- Be aware that 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 and as such, other interventions pose risks, as well, 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; prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
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