Inspire Medical Systems, Inc. announced that results from its STAR (Stimulation Therapy for Apnea Reduction) pivotal clinical trial have been published in the January 9 issue of the New England Journal of Medicine. The STAR trial was a multi-center clinical study designed to evaluate the safety and effectiveness of Inspire therapy in patients with moderate to severe OSA who were intolerant to Continuous Positive Airway Pressure (CPAP). The STAR trial was conducted at 22 medical centers across the United States and Europe.

In the STAR trial, patients implanted with Inspire therapy experienced a reduction in apnea events and improvements along several indices designed to measure quality of life. Endpoint results reported in the publication include: 68% median reduction in apnea hypopnea index (AHI). 70% median reduction in oxygen desaturation index (ODI).

Inspire Medical Systems is in the process of seeking approval from the FDA for use of Inspire therapy for patients with moderate to severe OSA, who are intolerant to CPAP.