U.S. FDA Approves Miniature LVAD for Children

The U.S. Food and Drug Administration said on Thursday it had granted a special exemption for a miniature heart device to keep alive children waiting for a heart transplant.

It approved a humanitarian device exemption for the specially designed left ventricular assist device (LVAD). “Use of the device may allow children with severe left ventricle failure to survive long enough to receive a heart transplant,” the FDA said in a statement,

The exemption means the company does not have to directly show that the device would be safe in children. Tests on similar devices used on adults suggested it would be safe for children, the FDA said.

While frequently used in adults, this would be the first left ventricular assist device approved for use in children. This particular device is called the DeBakey VAD Child, made by privately owned MicroMed Technology, Inc., of Houston.

The exemption is used to make 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,” the FDA said.