New Device Approved By FDA to Treat Sleep Apnea

A new device aimed at treating moderate to severe central sleep apnea was recently approved by the U.S. Food and Drug Administration. The Remede System stimulates nerves responsible for sending signals that promote breathing. The device is implanted under the skin in the upper chest area, and its thin wires are threaded through veins into the 

diaphragm. An external controller then programs the device to send small electrical stimuli that cause the diaphragm to contract and breathing to occur.

Data was evaluated by the FDA from 141 patients to determine the Remede’s effectiveness at reducing apnea hypopnea index, or AHI. This is a measure of how often and how severe each apneic episode is during sleep. The patients who received Remede implants saw a 50 percent reduction in AHI, compared to the patients without the device, who only saw an 11 percent reduction in AHI.

Treating Central Sleep Apnea 

There are actually three main types of sleep apnea, according to Dr. Kevin Pollock, DDS, MS, an oral and maxillofacial surgeon who treats patients with the most common form: obstructive sleep apnea.

“Central sleep apnea occurs when the brain doesn’t send the right signals to stimulate and control breathing during sleep,” he said. “Obstructive sleep apnea is caused by a blockage of the airways during sleep. The third form of sleep apnea is called mixed sleep apnea, or complex sleep apnea, and is a combination of central and obstructive.”

Since central sleep apnea is not as common as obstructive sleep apnea, the treatments for this condition are not as well known. A continuous positive airway pressure, or CPAP, machine is the go-to treatment method for all forms of sleep apnea, including central sleep apnea. It works by delivering a constant flow of pressurized air to keep the airway open during sleep. Another treatment option for those suffering from central sleep apnea is medication that can help stimulate breathing.

“It’s possible that central sleep apnea can be caused by another medical condition such as heart failure or stroke,” said Pollock. “For these patients, treating the cause of the sleep apnea can improve symptoms and overall health.”

Alternative to CPAP Machine 

This new device is a welcome alternative to the CPAP machine for many in the sleep apnea community. The biggest struggle most treating physicians have had with sleep apnea is patient compliance with their CPAP treatments.

According to studies conducted by the University of Pennsylvania School of Nursing and the Division of Biobehavioral and Health Sciences, between 29 and 83 percent of patients are non-adherent to their recommended CPAP treatments. This means these patients use the machine less than three hours a night or not at all.

“Many patients report that they find it harder to sleep with the CPAP machine than they did before treating the sleep apnea at all,” said Pollock. “This is a real problem because sleep apnea that goes untreated can be very dangerous and even potentially deadly. Finding a treatment option that not only works for the patient, but is also something they’re comfortable with is extremely important.”