The Food and Drug Administration (FDA) has issued an alert about the risk of a troubled heart pump, the Impella, puncturing a wall of the heart, leading to 49 deaths and numerous injuries worldwide. The tiny Impella pumps are used to take over the work of the heart in patients undergoing complex procedures or with life-threatening conditions. The FDA noted that the manufacturer, Abiomed, should have notified the agency about the risk sooner to provide a broader warning to hospitals and doctors. This alert highlights ongoing concerns about the deadly side effects of cardiac devices, particularly those that take over the heart’s blood-circulating function.
Multiple studies have indicated that the Impella heart devices increase the risk of death in patients with unstable medical conditions. However, Abiomed has continued to promote the device and compensate cardiologists with consulting payments and hospital grants. The FDA has received additional reports of heart wall tears linked to patient deaths following Abiomed’s initial notice about the device’s complications in 2021. This has led to the classification of the FDA’s alert as the most serious type of action, short of removing the device from the market.
There are currently 66,000 Impella pumps in the United States and 26,000 in other countries, and the number of Impella-related injuries has raised concerns among cardiologists. Some experts question the overall benefit of the devices, and whether an alert in the pump’s instruction manual will effectively prevent deaths. Abiomed, now owned by Johnson & Johnson MedTech, has defended the Impella device, stating that there have been no reported instances of heart wall perforations related to product design or manufacturing.
Abiomed has issued multiple warnings about Impella pumps over the past year that have been linked to serious injury or death. Despite being cleared for use by the FDA in 2008, concerns about the device’s safety persisted among cardiologists. The company has reported benefits of using Impella devices in nonemergency procedures, but studies have shown higher death rates and bleeding complications compared to other treatments. The elevated payments made by Abiomed to doctors and hospitals have raised questions about financial influences on device usage.
Researchers have highlighted the potential for Impella devices to cause serious bleeding complications, while urging greater scrutiny of the evidence supporting their use. Medicare data shows significant payments made by Abiomed to doctors and hospitals, indicating a financial incentive for promoting the devices. Johnson & Johnson MedTech’s acquisition of Abiomed underscores the significant revenue generated by the sale of Impella devices. Rigorous studies are needed to determine the best treatment approaches for patients using these devices.
