FDA approved implantable device for central sleep apnea

Central sleep apnea is a disorder where your breathing repeatedly pauses during sleep because the brain doesn’t send the proper signals to the diaphragm (these are the muscles that control your breathing).

The U.S. Food and Drug Administration (FDA) today approved a new treatment option for patients with moderate to severe central sleep apnea. It’s an implantable device called “The Remedé System” developed by Respicardia Inc.

The device is surgically placed under the skin in the upper chest area. Thin wires are inserted into the blood vessels near the nerve that’s responsible for sending signals to the diaphragm to stimulate breathing. The system monitors the patient’s respiratory signals during sleep, and when breathing is stopped, it stimulates the nerve that stimulates contraction of the diaphragm similar to normal breathing.

The FDA’s approval is based on a clinical trial involving 151 patients across Germany, Poland, and the USA. The study assessed the effectiveness of the device in reducing apnea hypopnea index (AHI) by 50% or more (AHI is a measure of the frequency and severity of apnea episodes). After 6 months of the treatment, just over half of the patients with the implanted device showed the reduction in AHI, compared to only 11% of the control group.

138 of the 151 participants did not report serious trial-related adverse events at 12 months. 27 (37%) of 73 patients in the treatment group reported non-serious therapy-related discomfort. As stated on the FDA website, “the most common adverse events reported included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The Remedē System should not be used by patients with an active infection or by patients who are known to require magnetic resonance imaging. This device is not intended for use in patients with obstructive sleep apnea, a condition in which the patient attempts to breathe, but the upper airway is partially or completely blocked.”

Please speak to your medical providers about the benefits and risks of the device, versus other available treatments.

Link to the original clinical trial: http://www.sciencedirect.com/science/article/pii/S0140673616309618?via%3Dihub

Link to FDA approval: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579506.htm

 

About Rina Soetanto

Rina Soetanto is currently doing her PhD in molecular biology. She also has an extensive background in pharmacology and pre-clinical cancer research, as well as an undergraduate science degree from the Australian National University with a double major in neuroscience and immunology.

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