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T04-05 |
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FDA today approved a Humanitarian Device Exemption (HDE) for a miniaturized heart pump for children aged 5 to 16 who are awaiting a heart transplant.
The product, called a ventricular assist device, is designed to help the left ventricle of the heart pump blood. Use of the device may allow children with severe left ventricle failure to survive long enough to receive a heart transplant.
The product is the DeBakey VAD Child, manufactured by MicroMed Technology, Inc., of Houston. While similar devices have been approved for use in adults, this is the first one to be approved for use in children.
An HDE is a special regulatory marketing approval that makes devices available on a limited basis for patients with rare medical conditions—those that affect fewer than 4,000 people annually in the United States. It is estimated that fewer than 100 children a year will be candidates for the new device.
FDA approved the HDE based on a review of data from 190 adults worldwide who were implanted with this device, and on extensive mechanical testing performed by MicroMed.
The data shows that the miniaturized device has a reasonable probability of being safe and effective in children. Without such a device, many children with severe left ventricle heart failure would die before a heart became available for transplant.
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