The U.S. Food and Drug Administration on Friday approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea (CSA). The Remed? System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.
“This implantable device offers patients another treatment option for central sleep apnea,” says 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, in a release. “Patients should speak with their healthcare providers about the benefits and risks of this new treatment compared to other available treatments.”
CSA occurs when the brain fails to send signals to the diaphragm to breathe, causing an individual to stop breathing during sleep for a period of 10 seconds or more before restarting again. According to the National Institute of Health’s National Center on Sleep Disorders Research, CSA can lead to poor sleep quality and may result in serious health issues, including an increased risk for high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes. Common treatment options for moderate to severe sleep apnea include medication, positive airway pressure devices (for example, CPAP), or surgery.
The Remed? System is comprised of a battery pack surgically placed under the skin in the upper chest area and small, thin wires that are inserted into the blood vessels in the chest near the nerve (phrenic) that stimulates breathing. The system monitors the patient’s respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing.
The FDA evaluated data from 141 patients to assess the effectiveness of the Remed? System in reducing apnea hypopnea index (AHI), a measure of the frequency and severity of apnea episodes. After 6 months, AHI was reduced by 50% or more in 51% of patients with an active Remed? System implanted. AHI was reduced by 11% in patients without an active Remed? System implanted.
The most common adverse events reported included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The Remed? System should not be used by patients with an active infection or by patients who are known to require magnetic resonance imaging (MRI). This device 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.
The FDA granted approval of Remed? System to Respicardia Inc.