FDA OKs Clinical Trial of Neurostimulation Therapy for OSA

Inspire Medical Systems has received approval from the US Food and Drug Administration (FDA) to begin a multicenter study, dubbed the STAR trial, that will evaluate both the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients with moderate to severe OSA.

“Current front line therapies for OSA, including CPAP, can have a significant impact on lifestyle and comfort for both the OSA patient and their bed partner,” said Tim Herbert, president and CEO of Inspire Medical Systems. “As a result, patient compliance for these front line therapies is suboptimal. Our goal with Inspire therapy is to significantly reduce the burden of sleep apnea and restore restful sleep without the lifestyle trade-offs that some other therapies require.”

Inspire Upper Airway Stimulation is an implantable therapy that works with the body’s natural physiology to prevent airway obstruction during sleep. While the OSA patient sleeps, Inspire therapy is designed to deliver physiologically timed, mild stimulation to the hypoglossal nerve on each breathing cycle. The stimulation is intended to restore tone to the muscles that control the base of the tongue, preventing the tongue from collapsing and obstructing the airway.

Medical centers in Germany, Belgium, and The Netherlands are currently approved to enroll patients into the STAR (Stimulation Therapy for Apnea Reduction) trial. The first US implants in the STAR trial are targeted for early 2011. Prior to the approval of the STAR trial, Inspire Medical Systems completed three independent feasibility studies in the United States, Europe, and Israel. Clinical data from those studies served as the basis for initiating the trial.

Inspire also received the CE Mark for its UAS therapy. “The receipt of the CE Mark is an important validation of our internal quality system and it authorizes the commercial sale of Inspire therapy in Europe,” Herbert said. “The company’s current focus is to conduct a robust pivotal trial. We will begin initial European market development activities in late 2011.”