November 30, 2010 - Inspire Device for Obstructive Sleep Apnea will be tested at sites in US and Europe – Inspire Medical Systems, a leading developer of neuro stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multi‐center study that will evaluate both the safety and effectiveness of Inspire™ Upper Airway Stimulation (UAS) therapy in patients with moderate to severe obstructive sleep apnea (OSA). The STAR trial will be conducted at leading medical centers across the United States and Europe. The results of this study will be the basis for a Pre‐market approval (PMA) application to the FDA.“OSA is a prevalent disorder affecting over 15 million adults in the U.S. alone. Current front line therapies for OSA, including CPAP, can have a significant impact on the lifestyle and comfort for both the OSA patient and their bed partner. As a result, patient compliance for these front line therapies is sub‐ optimal. A substantial number of patients suffering from OSA are looking for a new approach to treat this challenging condition,” commented Tim Herbert, President and CEO of Inspire Medical Systems. “Our goal with Inspire therapy is to significantly reduce the burden of sleep apnea and restore restful sleep without the lifestyle tradeoffs that some other therapies require.”... [PDF] Inspire Medical Systems' Press Release -
