Sleep Apnea Implant Device Receives FDA Approval
The most common adverse reactions included implant-site infection and swelling near the implant site.
HealthDay News — The Remede sleep system, an implanted device that treats central sleep apnea, has been approved by the US Food and Drug Administration.
The new system, including a battery pack implanted in the chest, stimulates the phrenic nerve and monitors a patient's lung function during sleep, the FDA said.
In clinical testing involving 141 individuals, the apnea hypopnea index was reduced by at least half among 51% of people who used the system. That compared with an 11% reduction among those who didn't have the system implanted.
The most common adverse reactions included implant-site infection and swelling near the implant site. The system should not be implanted in people with an active infection or among people who require use of a magnetic resonance imaging machine, the FDA said.
The system is produced by Respicardia Inc, based in Minnetonka, Minnesota.
FDA approves implantable device to treat moderate to severe central sleep apnea [press release]. Silver Spring, MD:FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579506.htm. Published October 6, 2017. Accessed October 11, 2017.