News from the FDA/CDC

FDA approves implantable device for central sleep apnea


 

The U.S. Food and Drug Administration on Oct. 6 approved an implantable device for the treatment of moderate to severe central sleep apnea.

The remedē System consists of a battery pack and small, thin wires placed under the skin in the upper chest area. The wires are inserted into the blood vessels in the chest to stimulate the phrenic nerve. The system monitors respiratory signals and, when it stimulates the nerve, the diaphragm moves to restore normal breathing.

This is a treatment for central sleep apnea and is not intended for use in patients with obstructive sleep apnea.

The agency’s approval comes on the basis of study results showing that the system reduced the apnea–hypopnea index scores by 50% or more in 51% of patients studied. Control patients in the study saw an 11% reduction in their score.

Adverse events reported in the study included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The remedē System is contraindicated for patients with active infection or who are known to require an MRI.

Recommended Reading

Sleep apnea in pregnancy linked to preterm birth
MDedge Pediatrics
Hypoxia of obstructive sleep apnea aggravates NAFLD, NASH in adolescents
MDedge Pediatrics
Pediatric OSA improved with oral montelukast
MDedge Pediatrics
Treatment plan addresses circadian rhythm disorders from nighttime screen use
MDedge Pediatrics
Roommates
MDedge Pediatrics
Adolescents and sleep, or the lack thereof
MDedge Pediatrics
Later school start tied to more sleep
MDedge Pediatrics
Late-to-bed adolescents may be early-to-diabetes
MDedge Pediatrics
OSA in pregnancy linked to congenital anomalies
MDedge Pediatrics
Improving children’s sleep may reduce internalizing problems long term
MDedge Pediatrics