The FDA has approved an implantable nerve stimulator (the Remede System) for moderate-to-severe central sleep apnea, the agency announced.
The system monitors respiratory signals during sleep and stimulates the phrenic nerve, which stimulates breathing, to move the diaphragm to restore normal breathing, according to an agency press release.
The device is comprised of a battery pack placed surgically under the skin in the upper chest and small leads that are inserted into the blood vessels in the chest near the phrenic nerve.
Premarket approval was based on a study of 141 patients randomized to the device or to a control group. After 6 months, a larger proportion of those in the device group had a reduction of 50% or more in the Apnea-Hypopnea Index (AHI) compared with controls (51% versus 11%), FDA said.
The most common adverse events included concomitant device interaction, implant site infection, swelling, and local tissue damage or pocket erosion.
Remede shouldn't be used by patients with an active infection or by those who are known to need frequent MRI. It's also not intended for use in obstructive sleep apnea, the agency stressed.
Central sleep apnea is tied to poor sleep quality and may boost the risk of hypertension, heart attack, heart failure, stroke, obesity, and diabetes, according to FDA. Common treatments include medication, positive airway pressure devices, or surgery.
The Remede System is made by Respicardia Inc., of Minnetonka, Minnesota.