The Food and Drug Administration has approved a Humanitarian Device Exemption for an implanted device to treat children who have Thoracic Insufficiency Syndrome, a term used to describe patients who have severe deformities of the chest, spine, and ribs that prevent normal breathing and lung development. An HDE is a special category of approval that allows a manufacturer to market a device on a limited basis to diagnose or treat patients with rare medical conditions–those that affect fewer than 4,000 people annually in the United States. Manufacturers of such products must demonstrate that the product is safe and has probable benefit to the patient which outweighs any risk of injury or illness that may be associated with its use.
From U.S. FDA:
FDA Approves Device to Treat Thoracic Insufficiency Syndrome
The Food and Drug Administration (FDA) has approved a Humanitarian Device Exemption (HDE) for an implanted device to treat children who have Thoracic Insufficiency Syndrome, a term used to describe patients who have severe deformities of the chest, spine, and ribs that prevent normal breathing and lung development.
An HDE is a special category of approval that allows a manufacturer to market a device on a limited basis to diagnose or treat patients with rare medical conditions–those that affect fewer than 4,000 people annually in the United States. Manufacturers of such products must demonstrate that the product is safe and has probable benefit to the patient which outweighs any risk of injury or illness that may be associated with its use.
The new device is the Vertical Expandable Prosthetic Titanium Rib, manufactured by Synthes Spine Co., of West Chester, Pa. The device is a curved metal rod that is attached to ribs near the spine using hooks located at both ends of the device. It is intended to help straighten the spine and separate ribs so that the lungs can grow and fill with enough air to breathe. The device is lengthened or replaced as the patient grows, requiring the patient to undergo repeat operations every six months.
Synthes studied use of the device in 147 children, ranging from ages six months to 15 years. The children had various serious defects affecting their ribs or chest wall and ability to breathe, including severe scoliosis (lateral curvature of the spine).
The study showed that the device was safe and showed probable benefit by enabling some of patients to breathe unassisted, or be less dependent on ventilators. There were 12 deaths that clinical researchers considered not related to a problem with the device.
The device is not intended to correct conditions other than chest wall instability. It should not be used in children younger than six months or those older than about age 14 for girls and age 16 for boys (i.e., children who are skeletally mature).