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Use of Impella Left Ventricular Assist Devices Should Be Stopped

Washington, D.C. — Abiomed has recalled the instructions for use for Impella left ventricular assist devices due to the risks of the device perforating the wall of the heart. The Food and Drug Administration (FDA) has issued a MedWatch notice, identifying the recall as Class 1, the most serious type. The devices are used for short term support of the ventricles (pumping chambers) of the heart, such as for myocardial infarction (heart attack) complicated by cardiogenic shock. Although there have been 129 reported serious injuries from the devices, including 49 reports of death, the FDA has allowed them to remain in use. Moreover, there are serious and ongoing concerns about whether there are clinically meaningful survival benefits that outweigh the risks of these left ventricular assist devices. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement.

Myocardial infarction complicated by cardiogenic shock is a devastating condition with a high mortality for which better treatments are urgently needed. Given the ongoing safety concerns about Impella left ventricular assist devices and this new recall, it is woefully inadequate to revise an instruction manual and to tell cardiologists to be more careful. The use of these left ventricular assist devices should be stopped. In the future, these devices should only be used in patients enrolled in a randomized controlled trial that compares the devices to medical management.”