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.
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