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FDA Gives Approval to an Implantable Device For Treating Central Sleep Apnea

By jeremyc | October 13, 2017

The FDA has given approval to a new treatment for people who have moderate or severe central sleep apnea. The new treatment is a tiny implantable device which works by stimulating a nerve present in chest that sends signals to our diaphragm to breathe. With the approval of this new treatment, central sleep apnea patients now have an additional treatment option.

In sleep apnea, the patient has shallow breaths or breathing pauses during sleep. A breathing pause can be of a few seconds or minutes.

In central sleep apnea, the brain doesn’t stimulate diaphragm to breathe, and this in turn causes a pause in breathing before breathing restarts. This form of sleep apnea is linked to poor quality of sleep, as well as greater risk to hypertension, heart failure, heart attack, diabetes, obesity, and stroke.

The FDA assessed data of 141 central sleep apnea patients to evaluate the device’s efficacy in lowering AHI (or apnea hypopnea index), used for measuring the severity and frequency of sleep apnea episodes. It was found that in case of 51 percent of sleep apnea patients who used the Remede System, AHI reduced by at least 50 percent following 6 months of use. Patients who didn’t use it recorded 11 percent reduction.




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