Inspire Medical Systems, a developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), has received approval from the US Food and Drug Administration (FDA) to begin its STAR (Stimulation Therapy for Apnea Reduction) pivotal clinical trial.
The STAR trial 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).
Inspire Upper Airway Stimulation (UAS) therapy is an implantable therapy that works with the body’s natural physiology to prevent airway obstruction during sleep.
Inspire therapy is designed to deliver physiologically timed, mild stimulation to the hypoglossal nerve on each breathing cycle.
Inspire Medical said that the STAR trial will be conducted at leading medical centers across the US and Europe and the results of the study will be the basis for a Pre-market approval (PMA) application to the FDA.
Inspire Medical Systems president and CEO Herbert said that the company’s current focus is to conduct a robust pivotal trial and they will begin initial European market development activities in late 2011.
"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.