FDA approves Remedē System for moderate to severe central sleep apnea

The FDA approved the Remed System to treat patients with moderate to severe central sleep apnea.

The Remed System (Respicardia) is an implantable device that stimulates a nerve, located in the chest, responsible for sending signals to the diaphragm to stimulate breathing.

“This implantable device offers patients another treatment option for central sleep apnea,” 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, said in a press release. “Patients should speak with their health care providers about the benefits and risks of this new treatment compared to other available treatments.”

The device is 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 to stimulate breathing. The Remed System monitors the patient’s respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing.

The agency’s decision included data from a trial designed to evaluate the efficacy of the system in 141 patients with moderate to severe central sleep apnea.

After 6 months, 51% of patients demonstrated a 50% reduction in apnea hypopnea index, a measure of the frequency and severity of apnea episodes, compared with only 11% of patients who did not have the device implanted.

The most common adverse events included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion.