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FDA Approves First Sleep Apnea Implant

Neurostimulation keeps airway open

The FDA has approved Inspire upper airway stimulation (UAS) therapy (Inspire Medical Systems, Inc.) for use in a subset of patients with moderate-to-severe obstructive sleep apnea (OSA) who are unable to use continuous positive airway pressure (CPAP). Inspire therapy is a fully implanted neurostimulation device, the first of its kind for sleep apnea.

According to the National Sleep Foundation, OSA affects approximately 18 million Americans. Research has shown that an individual with poorly managed OSA is at increased risk for heart attack, stroke, weight gain, hypertension, heart failure, and falling asleep while driving. Sleep apnea can also be disruptive to a person’s everyday activities, causing depression, spousal/interpersonal problems, irritability, and daytime fatigue.

Current treatments for OSA include CPAP, weight loss, oral appliances, and anatomy-altering surgeries. CPAP is the current standard of care for the management of OSA. It is often successful, but recent studies have shown that roughly half of all patients who start CPAP do not continue to use it consistently.

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 remote device 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 apnea, Inspire therapy does not require the removal or permanent alteration of facial or airway anatomy.

Patients implanted with Inspire therapy who participated in the pivotal STAR (Stimulation Therapy for Apnea Reduction) trial experienced a 68% reduction in apnea 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 in the U.S. in the second half of 2014.

Source: Inspire Medical Systems; May 1, 2014.

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