The United States Food and Drug Administration has approved a new treatment for those with sleep apnea.
Respicardia’s Remedē System is an implantable device that works to stimulate a nerve in the chest that sends signals to the diaphragm to prompt breathing, the FDA reports.
It is made up of a battery pack inserted under the skin in the chest area with small wires inserted near the nerve. The system monitors an individual’s respiratory signals.
Sleep apnea is a disorder in which individuals to have pauses in breathing or shallow breaths during sleep. The pauses can last from a few seconds to minutes, according to the FDA.
“This implantable device offers patients another treatment option for central sleep apnea,” said Tina Kiang, Ph.D., acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices in the FDA’s Center for Devices and Radiological Health.
In evaluating the Remedē System, the FDA observed 141 patients. Six months into the study, the apnea hypopnea index (AHI) – a measure of the frequency and severity of apnea episodes – AHI went down by 50 percent or more in 51 percent of those with the system, the FDA reports. AHI was reduced by only 11 percent in those without the system.