FDA Approves Implantable Sleep Apnea Device

The US Food and Drug Administration (FDA) has approved an implantable device for moderate-to-severe central sleep apnea.

The Remedē System, a device that stimulates diapgrahm-signalling nerves in the chest to aid in the breathing process, was approved on data involving 141 patients assessed on the apnea hypopnea index (AHI). After 6 months of treatment, about half of the patients had reported a reduction in AHI by 50% or more.

The device is comprised of a battery pack surgically placed subcutaneous in the upper chest area. Thin wires are inserted into the blood vessels near the phrenic nerve, which stimulates breathing. During sleep, the device monitors respiratory signals and stimulates the nerve to move the diaphragm and restore normal breathing.

Central sleep apnea can cause patients to stop breathing during sleep for 10 seconds or more before restarting. The condition can lead to health issues such as cardiovascular disease or events, obesity, and diabetes.

The most common adverse events reported included concomitant device interaction, implant site infection, swelling, and local tissue damage. The Remedē System is not intended for use in patients with obstructive sleep apnea, a condition in which the patient attempts to breathe, but the upper airway is partially or completely blocked.

Tina Kiang, PhD, 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, advised patients speak with their doctors about the benefits and risks of the device, versus other available treatments.