Device stimulates diaphragm-regulating nerve in chest to restore normal breathing.

An implantable device that has the potential to replace the continuous positive airway pressure (CPAP) machine to treat moderate to severe central sleep apnea has been approved by the FDA. The Remedē System, developed by Respicardia, a medical device company headquartered in Minneapolis, is one of the first implantable treatments for sleep apnea approved by the FDA.

Sleep apnea, is a common disorder that causes people’s breathing to pause or become shallow during sleep. These breath-pauses caused by sleep apnea range from seconds to minutes, and can lead to poor health outcomes. The Remedē system stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.

According to the National Institute of Health’s National Center on Sleep Disorders research, sleep apnea is associated with increased risk of high blood pressure, heart attack, hear failure, stroke and complications related to diabetes and obesity. Treatments for this condition are relatively limited, either to medication, positive airway pressure devices (e.g., CPAP) or surgery.

“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. “Patients should speak with their health care providers about the benefits and risks of this new treatment compared to other available treatments.”

Comprised of a battery pack surgically placed under the skin in the upper chest area, the Remedē system’s wires are inserted into the blood vessels in the chest near the phrenic nerve to stimulate breathing. Data from 141 patients were evaluated, to assess the device’s ability in reducing apnea hypopnea index (AHI). This index measures the frequency and severity of apnea episodes. The FDA reports, that after six months AHI was reduced by 50% or more in 51% of patients with the active implant.