FDA Warns of Adverse Events Associated With LVADs
The U.S. Food and Drug Administration (FDA) issued an alert on July 5 concerning serious adverse events associated with implantable left ventricular assist devices (LVADs). These adverse events include increased rate of pump thrombosis with Thoratec’s HeartMate II, a high rate of stroke with the HeartWare HVAD, and a risk of bleeding complications with both devices.
According to the FDA, “when used for the currently approved indications in appropriately selected patients, [we believe] the benefits of these LVADs continue to outweigh the risks”. However, health care professionals are advised to take these risks into consideration before recommending an LVAD device for patient use.
Keywords: Heart-Assist Devices, Stroke, Thrombosis, United States Food and Drug Administration
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