FDA approves ‘pacemaker’ for treating sleep apnea

FDA approves ‘pacemaker’ for treating sleep apnea

New treatment option approved for sleep apnea patients that cannot use CPAP will consist of fully implanted pacemaker-like stimulator.

Sleep apnea affects an estimated 18 million Americans and is not only disruptive because of loud snoring but is also a serious health condition. Mild sleep apnea may be corrected by weight loss and training the patient to sleep in positions other than on the back. In more serious cases, special devices or surgery may be necessary. Because of its invasiveness, surgery is usually a last resort. Unfortunately, the most often used devices, continuous positive airway pressure (CPAP) machines, are noisy, cumbersome, and uncomfortable.

Now, there is a new option for those who suffer from sleep apnea that cannot be corrected with weight loss, sleep repositioning, or for those who cannot use CPAP machines. Inspire Medical Systems, Inc. received approval on Thursday from the U.S. Food and Drug Administration (FDA) to market Inspire Upper Airway Stimulation (UAS) therapy to patients with moderate to severe Obstructive Sleep Apnea (OSA). The therapy involves the implantation of a device that senses breathing patterns and stimulates muscles in the problem areas to constrict and keep the airway open.

“All of us at Inspire Medical Systems are committed to improving the health and quality of life for these individuals with OSA, and we are excited to make this innovative and much needed treatment available to patients and physicians,” said Tim Herbert, Inspire Medical Systems president and CEO.

Patients who suffer from OSA experience periodic relaxation of the tongue muscles and collapses of the airway, resulting in blocked respiration for anywhere from ten seconds to a minute while the sleeping person struggles to breathe. This results in interrupted sleep, next-day drowsiness, chronic oxygen deprivation, and more long-term cardiovascular effects such as high blood pressure, heart attack, and stroke.

“Patients with moderate to severe OSA who are not on effective treatment are at an increased risk for cardiovascular disease, accidents and death,” said Meir Kryger at Yale School of Medicine. “There is a significant need for safe, effective and well-tolerated new treatments in the sleep medicine field.”

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