FDA Clears Implantable Device for Central Sleep Apnea — Physician’s First Watch
FDA Clears Implantable Device for Central Sleep Apnea
By Kelly Young
The FDA has cleared the Remedē System to treat patients with moderate-to-severe central sleep apnea.
With this system, a battery pack is implanted under the skin of the upper chest. Thin wires are inserted into the patient's phrenic nerve, which stimulates breathing. When the device senses that normal breathing has been interrupted during sleep, it stimulates the phrenic nerve to move the diaphragm and prompt normal breathing.
In a trial of nearly 150 patients with central sleep apnea, most of whom had heart failure, the system reduced the apnea hypopnea index score by 50% in more than 51% of patients at 6 months. In comparison, among those with the device implanted but not activated, only 11% had a score reduction of 50% or more.
Some of the common adverse events included concomitant device interaction, infection at the implant site, and swelling and local tissue damage or pocket erosion.