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# FDA Approves Respicardia PMA for Sleep Apnea
- URL: https://www.fdaweb.com/fda-approves-respicardia-pma-for-sleep-apnea/
- Published: 2017-10-09T12:00:00.000Z
- Updated: 2026-09-14T22:55:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139821

FDA has approved a Respicardia PMA for the Remed System as a treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The implantable device stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing, according to an [FDA release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579506.htm?ref=fdaweb.com). The system comprises a battery pack surgically placed under the skin in the upper chest and thin wires that are inserted into the blood vessels in the chest near the nerve (phrenic) to stimulate breathing. “The system monitors the patient's respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing,” the agency says.

Approval was based on data from 141 patients whose apnea hypopnea index (AHI), a measure of the frequency and severity of apnea episodes, was assessed. After six months, AHI was reduced by 50% or more in 51% of patients with an active device implanted, the agency says. “AHI was reduced by 11% in patients without an active Remed System implanted,” it adds. “The most common adverse events reported included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion.”