Heart assist device available for children

FDA Consumer, May-June, 2004

The FDA has approved a miniaturized heart pump for children ages 5 to 16 who are awaiting a heart transplant. While similar devices have been approved for use in adults, this is the first one to be approved for use in children.

The DeBakey VAD Child, a ventricular assist device, was approved in February 2004 under the humanitarian device exemption (HDE), which makes devices available on a limited basis for patients with rare medical conditions. The 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.

An HDE is a special regulatory marketing approval available for medical devices to treat conditions 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.

The device is manufactured by MicroMed Technology Inc. of Houston.