Inspire Medical Systems has announced that the US Food and Drug Administration (FDA) has approved Inspire upper airway stimulation therapy for use in a subset of patients with moderate to severe obstructive sleep apnoea who are unable to use continuous positive airway pressure. Inspire therapy is a fully implanted neurostimulation device, the first of its kind for sleep apnoea, that provides an alternative treatment that is proven, convenient and easy to use.
Current treatments for obstructive sleep apnoea include weight loss, continuous positive airway pressure, oral appliances and anatomy altering surgeries. Continuous positive airway pressure is the current standard of care for obstructive sleep apnoea management. It is often successful but recent studies have shown that roughly half of all patients that start continuous positive airway pressure do not continue to consistently use it.
Inspire therapy is a fully implanted system consisting of three components: a small generator, a sensing lead and a stimulation lead. The single external component is a small handheld Inspire sleep remote used to turn the therapy on before bed and off upon waking. When activated, Inspire therapy senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep. In contrast to other surgical options to treat sleep apnoea, Inspire therapy does not require removal or permanent alteration of facial or airway anatomy. As such, the procedure is less invasive and should result in a shorter recovery time.
“This therapy represents a major advance in sleep apnoea treatment for some patients who are unable to use or tolerate continuous positive airway pressure therapy,” says Meir Kryger, professor, Yale School of Medicine. “Patients with moderate to severe obstructive sleep apnoea who are not on effective treatment are at an increased risk for cardiovascular disease, accidents and death. There is a significant need for safe, effective and well-tolerated new treatments in the sleep medicine field.”
Patients implanted with Inspire therapy who participated in the company’s STAR (Stimulation therapy for apnoea reduction) pivotal clinical trial experienced a 68% reduction in apnoea events, a 70% reduction in oxygen desaturation events, and significant improvements in daytime functioning as measured by two validated questionnaires. These results were published in the January 9, 2014 issue of the New England Journal of Medicine.
Inspire therapy will be commercially available to patients in the United States in the second half of 2014.