The U.S. Food and Drug Administration has approved a new treatment option for patients who have moderate to severe central sleep apnea.
Central sleep apnea is different from obstructive sleep apnea, in which partial or complete closure of the upper airway interferes with breathing. In central sleep apnea, the brain fails to send signals down the phrenic nerve (which runs from the neck to the diaphragm) to cause the diaphragm to breathe.
Central sleep apnea may be the result of heart failure, stroke, or other medical conditions.
Respicardia’s Remedē System is an implantable device located in the chest that stimulates the phrenic nerve to send the signal to the diaphragm to breathe.
A battery pack is surgically placed under the skin in the upper chest area with small, thin wires inserted into the blood vessels in the chest near the phrenic nerve. The system monitors the patient’s respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing.
“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 a statement.
“Patients should speak with their health care providers about the benefits and risks of this new treatment compared to other available treatments,” she added. Current treatments include medication, surgery, or use of a continuous positive airway pressure device (CPAP), either on its own or assisted with an adaptive servo-ventilator, which monitors breathing and responds with extra pressure and possibly extra oxygen when the normal breathing pattern goes awry.
The most common adverse events include concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. Remedē System is not recommended for those with obstructive sleep apnea or those who require magnetic resonance imaging or have an active infection.
The FDA based their approval on clinical trial results from 141 patients. The study assessed the effectiveness of the Remedē System in reducing Apnea-Hypopnea Index (AHI), a measure of the frequency and severity of apnea episodes.
After six months, AHI was reduced by 50 percent or more in 51 percent of patients with an active Remedē System implanted. AHI was reduced by 11 percent in patients without an active Remedē System implanted.