The US Food and Drug Administration (FDA) has approved a new treatment option for patients who have been diagnosed with moderate-to-severe central sleep apnea. The Remedē System, manufactured by Respicardia, Inc., is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing. Respicardia, Inc. is headquartered in Minnetonka, MN.

Indications: The Remedē 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.

Adverse effects: The most common adverse events reported included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The Remedē System should not be used by patients with an active infection or by patients who are known to require magnetic resonance imaging.