Implant to Treat Central Sleep Apnea Approved by FDA

October 06, 2017

The US Food and Drug Administration (FDA) today approved an implantable device that treats moderate-to-severe central sleep apnea (CSA) by stimulating a nerve to move a patient's diaphragm when the brain doesn't.

The device, called the remedē System (Respicardia), is a battery pack implanted in the upper chest under the skin. The device's tiny wires send electrical current to the phrenic nerve, which descends from the neck to innervate the diaphragm.

In CSA, the brain doesn't send the usual signals down the phrenic nerve to cause the diaphragm to breathe. CSA increases the risk for conditions such as high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes.

The FDA determined that the remedē System was safe and effective based on clinical-trial results for 141 patients. After 6 months, 51% of patients implanted with an active remedē System saw at least a 50% reduction in their apnea-hypopnea index (AHI), which measures the severity and frequency of sleep apnea, the agency said in a news release. In contrast, AHI decreased by only 11% for control-group patients who had an implanted device that was turned off.

Concomitant device interaction, implant site infection, swelling, and local tissue damage or pocket erosion were the most common adverse events observed in the trial.

The remedē System is not recommended for patients with an active infection or those undergoing magnetic resonance imaging, according to the FDA. And it's not meant for patients diagnosed with obstructive sleep apnea, in which partial or complete closure of the upper airway interferes with breathing.

More information about today's announcement is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert


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