Remede System Approved for Central Sleep Apnea
MONDAY, Oct. 9, 2017 -- The Remede sleep system, an implanted device that treats central sleep apnea, has been approved by the U.S. 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 percent of people who used the system. That compared with an 11 percent 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.
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Posted: October 2017