FDA approves Inspire UAS therapy for Obstructive Sleep Apnea-Inspire Medical

The FDA has approved Inspire Upper Airway Stimulation (UAS) therapy, from Inspire Medical Systems, 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. Current treatments for OSA include weight loss, CPAP, oral appliances and anatomy altering surgeries.

Patients implanted with Inspire therapy who participated in the company�s STAR pivotal clinical trial experienced a 68 percent reduction in apnea events, a 70 percent 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.