The FDA cleared Respicardia’s neurostimulation implant for the treatment of sleep apnea. The Remede system stimulates a nerve in the chest that prompts the diaphragm to restore breathing.
Sleep apnea describes a disorder where a person has one or more pauses in their breathing during sleep. These pauses may last anywhere from a few seconds to minutes, according to the NIH, and can disrupt sleep and cause excessive daytime sleepiness. It is typically treated with lifestyle changes, mouthpieces, breathing devices, such as continuous positive airway pressure (CPAP) machines and surgery.
"This implantable device offers patients another treatment option for central sleep apnea," said Tina Kiang, 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."
The Remede system comprises a neurostimulation implant, leads for sensing and delivering stimulation and a portable tablet for programming treatment. It monitors a patient’s breathing during sleep and stimulates a nerve to restore normal breathing, the FDA said in the statement.
The approval is based on a 141-patient study investigating how well the system reduced the frequency and severity of apnea episodes, measured by the apnea hypopnea index (AHI). The study found that six months after implantation, the AHI was at least halved in 51% of patients. The AHI score dropped only 11% in patients that did not receive the Remede implant.
A number of devicemakers are working on alternatives to bulky CPAP machines, including the Belgian-Israeli Nyxoah, which picked up $20 million last year to develop a neurostimulation-based treatment for sleep apnea. NightBalance, based in the Netherlands, raised nearly $14 million for its sleep position trainer, which vibrates when a patient rolls onto his or her back, prompting a position change and reducing apnea.