Thermo Cardiosystems has announced that the U.S. Food and Drug Administration (FDA) has approved the company's request to begin evaluating the HeartPak portable driver outside the inpatient environment.
The HeartPak is a battery-powered, compact, external power source designed for home use in conjunction with the company's pneumatic HeartMate left ventricular assist system (LVAS), which received FDA approval in 1994 as a bridge to transplantation. HeartPak is commercially available in Europe and Asia.
So far, most patients participating in an ongoing clinical trial of the device in the United States have been confined to a hospital; however, the FDA approval will allow patients to be routinely discharged from the hospital.
"We're pleased that patients supported by our pneumatic HeartMate system and the HeartPak portable driver will be able to wait for a donor heart in their own homes, just as patients supported by our electric HeartMate LVAS," said R. Michael Klein, chief executive officer of Thermo Cardiosystems.
The company's pneumatic and electric HeartMate assist devices are approved for commercial sale in the United States, Europe, and Canada, and parts of Asia.
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