The Food and Drug Administration is warning about adverse health risks identified with two models of implantable heart devices used to help sustain patients waiting for heart transplants.
The ">FDA on Wednesday identified
The agency cited two analyses that found thrombosis occurred in 8.4% of patients at three months after the devices were implanted, and in 6% of patients at six months. Clinical trial results at the time showed a rate of thrombosis occurring in 1.6% of implanted devices at one year and in 3.8% of patients at the two-year mark.
The agency also issued a warning regarding Framingham, Mass.-based maker HeartWare's HVAD ventricular pump after results of a recent clinical trial found an increased rate of stroke over two years compared with the HeartMate device made by Thoratec.
Both devices were found to be associated with bleeding complications, the cause of which was not fully understood, according to the agency.
The devices are the only two currently approved by the FDA to provide circulatory support to a patient at risk of imminent death from non-reversible left ventricular heart failure. HeartMate is approved for use as both a bridge for patients awaiting transplant and for use among patients with end-stage ventricular heart failure who are ineligible for transplant. HeartWare's device is approved only for use as a bridge to transplant.
“The FDA recognizes that LVADs are life-sustaining, life-saving devices for patients with advanced left ventricular heart failure,” the agency wrote. “When used for the currently approved indications in appropriately selected patients, we believe the benefits of these LVADs continue to outweigh the risks. However, the FDA also believes it is important for healthcare providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients.”
The FDA has not called for any action to be taken against either product maker or for a recall of the devices, stating the benefits of the devices. Instead, the agency has recommended healthcare providers perform thorough examinations of patients to assess their risk for thrombosis, stroke or bleeding.
Both companies are conducting studies to assess the issues related to each device. Attempts to reach Thoratec and HeartWare were unsuccessful late Wednesday afternoon.
