(RxWiki News) The US Food and Drug Administration (FDA) has approved a new implantable device to treat moderate to severe central sleep apnea.
The newly approved Remedē System is a small battery pack and wires that are implanted under the skin near the chest. The FDA approved it to treat sleep apnea after it appeared safe and effective in data from 141 patients.
In patients with sleep apnea, breathing stops and starts repeatedly. This condition can lead to a host of medical problems if it's left untreated. These include strokes, high blood pressure, heart problems, depression, diabetes and headaches, among others.
In central sleep apnea — the condition this new device is approved to treat — the brain fails to signal the diaphragm that it's time to breathe. According to the FDA, the Remedē System works by using electricity to stimulate a nerve that tells the diaphragm to breathe.
“This implantable device offers patients another treatment option for central sleep apnea,” said Dr. Tina Kiang, acting director of the FDA's Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices, 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.”
Patients who have infections or who must undergo magnetic resonance imaging should not use the Remedē System, according to the FDA. Common adverse events tied to this device included infections at the implant site, swelling and tissue damage and interactions with other medical devices.
The Remedē System is not approved for use in patients with obstructive sleep apnea, the FDA noted. Talk to your health care provider about the best treatment for your sleep disorder.
Respicardia Inc. markets the Remedē System.