A new sleep apnea implant was approved Monday by the U.S. Food and Drug Administration to treat moderate to severe sleep apnea.
The device, called the Remede System, works by stimulating a nerve in the chest that sends signals to the diaphragm to cause breathing, according to an FDA news release.
Sleep apnea causes patients to stop breathing or breathe too shallowly as they sleep, with pauses lasting a few seconds to more than a minute. The condition causes poor sleep quality and can lead to serious health issues such as high blood pressure, heart attack or failure, stroke, obesity, and diabetes.
Current treatment options for moderate to severe sleep apnea include medication, machines to keep the airway open, or surgery.
A study of the new implant showed the apnea hypopnea index (AHI), which measures the severity of the apnea, was reduced 50 percent or more in 51 percent of the 141 patients given the Remede System, compared to an 11 percent reduction in patients who didn’t have the Remede System implanted, the FDA reported.
The device can’t be used with patients who have obstructive sleep apnea, which occurs when the upper airway is blocked during sleep.
Some adverse events were reported, including infection at the site of implantation, swelling, local tissue damage, and interaction between the Remede System and other devices.
The system consists of a battery pack implanted under the skin and wires that are inserted into the blood vessels in the chest near the phrenic nerve, which stimulates breathing. When a patient stops breathing, the nerve is stimulated to move the diaphragm and get the patient breathing again.
Up to 18 million Americans reportedly have sleep apnea. Most are either middle age males or are overweight.
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