The remedē System: A New Approach to Treating Sleep Apnea

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By Emily Majorkiewicz

Affecting over 200,000 people in the United States alone, sleep apnea is quite a common sleeping disorder that is characterized by frequent pauses in ventilation, usually causing a person to awaken [5]. These lapses in breathing can be frequent and disrupt the circadian rhythm, causing the affected to feel persistent fatigue.  This condition is often difficult to diagnose, as there are no obvious symptoms of sleep apnea besides fatigue, and diagnosing it typically requires a sleep study [5].

Once diagnosed, a common treatment for sleep apnea involves putting on a continuous positive airway pressure device (CPAP) before sleeping. This ventilation gear is essentially a mask that encases the mouth and nose, continuously blowing a stream of air into the ventilation pathways to keep them from collapsing and disturbing sleep [4]. Additional traditional methods may involve surgery or dental appliances that aim to reposition the jaw to maximize airflow [4]. There is now, however, a new device that may make these old methods pale in comparison.

The remedē System is a brand new device that has recently been approved by the Federal Drug Administration, with the purpose of treating severe forms of sleep apnea in adults. This innovative battery-powered device is implanted into the chest area directly under the skin, where it generates a pulse whenever necessary [2]. The system has a wire that contacts the phrenic nerve, which is responsible for the autonomic breathing function. When a certain stimulus alerts the device, a wire will signal to the nerve to make the diaphragm muscle contract [2]. This stimulation will allow the user to take a breath and remain within his or her sleep stage.

Unlike other sleep apnea devices, the remedē System is unique in that it has two different functional settings that can be customized to fit the patient’s specific needs. It can be used to either generate pulses in between certain time intervals, or it can be set to only stimulate the phrenic nerve when there is a lapse in breathing [2]. The system is also designed to only deliver pulses during certain periods of the day — for example, when the person is more likely to be asleep — and requires that the person be lying down before activating [2]. In clinical studies that involved over 173 sleep apnea patients, symptoms were significantly diminished in patients who used the device [1,3]. Despite these promising results, there is still room for improvement, as a reported 26 percent of patients required repositioning of the device at some point during the study [1]. All in all, with improvement, the remedē System may become the primary device for effectively treating the many individuals suffering from sleep apnea.

References

  1. Abraham, W.T., Jagielski, D., Oldenburg, O., Augostini, R., Krueger, S., Kolodziej, A., Gutleben, K.J., Khayat, R., Merliss, A., Harsch, M.R., Holcomb, R.G., Javaheri, S., Ponikowski, P. Phrenic nerve stimulation for the treatment of central sleep apnea. 2015. JACC Heart Fail. 3(5): 360-369. LINK: https://www.ncbi.nlm.nih.gov/pubmed/25770408
  1. Center for Devices and Radiological Health. “Remedē® System – P160039.” U S Food and Drug Administration Home Page, Center for Devices and Radiological Health, 6 Oct. 2017. LINK: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm579412.htm.
  1. Costanzo, M.R., Augostini, R., Goldberg, L.R., Ponikowski, P., Stellbrink, C., Javaheri, S. Design of the remedē System Pivotal Trial: A Prospective, Randomized Study in the Use of Respiratory Rhythm Management to Treat Central Sleep Apnea. 2015. J Card Fail. 21(11): 892- LINK: https://www.ncbi.nlm.nih.gov/pubmed/24726495
  1. “How Is Sleep Apnea Treated?” Sleep Disorder Problems, National Sleep Foundation, 2017. LINK: https://sleepfoundation.org/sleep-disorders-problems/sleep-apnea-treatment
  1. “What Is Sleep Apnea?” National Heart Lung and Blood Institute, U.S. Department of Health and Human Services, 10 July 2012. LINK: https://www.nhlbi.nih.gov/health/health-topics/topics/sleepapnea/
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