FDA Approves Implantable Device for Sleep Apnea
The U.S. Food and Drug Administration has approved a new treatment for people diagnosed with moderate or severe central sleep apnea. Called the Remedē System, the implantable device stimulates a nerve in the chest that sends signals to the diaphragm to stimulate breathing.
In people with central sleep apnea, the brain fails to signal the diaphragm to breathe during sleep, causing pauses in breathing that can last 10 seconds or longer, up to 100 times an hour. Untreated sleep apnea leads to poor sleep quality and increases the risk for serious health problems including high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes.
This new device is comprised of a battery pack that is surgically placed under the skin in the upper chest area and small wires that are inserted into blood vessels in the chest near the phrenic nerve, which stimulates breathing. The Remedē System monitors respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing. It is not approved for use in people with obstructive sleep apnea, a condition that occurs when the upper airway is partially or completely blocked during sleep.