FDA Approval for New Implanted Apnea Device

We told you back in January about a new implantable device that could replace CPAP treatment for some sleep apnea sufferers.  That device has just taken one more step toward becoming available to the general public, with approval by the FDA.

Obstructive sleep apnea, or OSA, is characterized by repeated episodes of upper airway collapse during sleep, due to narrowing or blockage. Patients with OSA stop breathing frequently during sleep, often for a minute or longer. Repeated episodes of apnea can lead to daytime fatigue, and increase a person’s risk for heart attack, stroke, high blood pressure and even death.  Standard treatments for OSA include weight loss, upper airway surgeries, oral appliances, and continuous positive airway pressure (CPAP).

This new treatment, called the Inspire Upper Airway Stimulation, is a neurostimulator device that’s similar to a pacemaker. Inspire, which is implanted in the chest, has a small generator, a sensing lead and a stimulator. A patient also receives a remote control to turn the therapy on before bedtime and off in the morning. When the device is activated it senses the person’s breathing patterns.  When an apnea episode begins, it stimulates one of the nerves that goes to the upper airway, helping to hold the airway open during sleep.

“This therapy represents a major advance in sleep apnea treatment for some patients who are unable to use or tolerate CPAP therapy,” said Meir Kryger, MD, professor, Yale  School of Medicine. “Patients with moderate to severe OSA who are not on effective treatment are at an increased risk  or cardiovascular disease, accidents and death.  There is a significant need for safe, efective and well-tolerated new treatments in the
sleep medicine field.”

In clinical trial of the device on 126 patients, 68 percent experienced less sleep apnea and 70 percent had a reduction in oxygen desaturation as well as improved function in the daytime, according to the paper published in the New England Journal of Medicine in January.

The company that makes Inspire says it will be available in the second half of this year.  Read more about it in this press release.

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