On May 21, 2019, the FDA issued an update to an earlier letter to health care professionals to inform them about the most recent, interim post-approval study results for the Abiomed Impella RP System, provide recommendations for health care providers and outline the ongoing steps being taken to better understand the benefits and risks.
February 4, 2018
“Our understanding of a device’s benefits and risks can evolve throughout a device’s total product lifecycle based on information we gain from the various tools we use to monitor device safety and efficacy, such as real-world evidence and studies conducted after a device is on the market. The FDA can require sponsors to conduct post-approval studies to help ensure the continued safety and effectiveness of the device once it is on the market,” said Jeff Shuren, M.D., director of the Center for Radiological Devices and Health. “Today we are communicating about new information we received from interim results of a required post-approval study for a specific heart pump used in patients who need temporary emergency support to maintain stable heart function. The study is doing exactly what post-approval studies are designed to do—provide more information about a device’s benefit-risk profile by studying the performance and outcomes of device use in real-world clinical settings. We are thoroughly reviewing the data. Until we know more, we’re giving health care providers recommendations to consider when making treatment decisions. We’re committed to early, transparent communications with health care providers and patients when safety signals emerge, and we’ll continue to communicate about this issue as we learn more.”
Today, the FDA issued a Letter to Health Care Providers alerting them that the agency is evaluating post-approval study interim results that suggest a higher risk of death (mortality rate) than was observed in clinical studies prior to the device’s approval in patients treated with a temporary heart pump called the AbioMed Impella RP System. The pump system is a temporary mechanical circulatory support device intended to help patients maintain stable heart function without additional open chest surgery. It is inserted into the right ventricle and pulmonary artery of the heart for no more than 14 days and then removed. The patient remains in the hospital while the pump is implanted. In the premarket clinical studies supporting approval of the device, 73 percent of patients survived for at least 30 days after the device was removed or after they were discharged from the hospital (whichever was longer) or until they started a longer-term therapy such as the implant of a durable right Ventricular Assist Device (VAD) or a heart transplant. In the post-approval study required by the FDA, interim results showed a higher mortality rate in patients enrolled in the ongoing study, with a total of 17 percent of patients surviving using the same endpoints. The data so far suggests this higher mortality rate may be related to differences in patient characteristics from the premarket studies. Specifically, before being implanted with the Impella RP system, patients in the post-approval study were more likely than patients in the premarket studies to have been in shock for longer than 48 hours, experienced an in-hospital cardiac arrest, had an intra-aortic balloon pump, or had a stroke or lack of blood flow to the brain.
The FDA is carefully evaluating this data and has not determined the root cause for the higher mortality rate. It’s also important to note that the study population had additional health conditions that increased their risk of death compared to the premarket study population.
The FDA believes that when the device is used for the approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks. The FDA is recommending that health care providers carefully consider information about the characteristics of patients enrolled in both the premarket and postmarket studies for this device when making treatment decisions about who may benefit from the Impella RP System and discuss the benefits and risks of the device with patients and their caregivers. It’s important to note that while the data is concerning, the Impella RP System may be the best option for some patients requiring emergency treatment with a temporary heart pump.
The agency encourages prompt reporting of adverse events or suspected adverse events experienced with these devices through its MedWatch reporting system.
The FDA will continue to communicate about this issue as more information becomes available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.