Inspire Medical Systems has announced that the company has received approval from the USA Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multicentre 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
The STAR trial will be conducted at leading medical centres across the United States and Europe. The results of this study will be the basis for a pre-market approval application to the FDA.
“Obstructive sleep apnea is a prevalent disorder affecting over 15 million adults in the USA alone. Current front line therapies for obstructive sleep apnea, including CPAP, can have a significant impact on the lifestyle and comfort for both the patient and their bed partner. As a result, patient compliance for these front line therapies is suboptimal. A substantial number of patients suffering from the disease are looking for a new approach to treat this challenging condition,” said 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.”
“Patients with untreated sleep apnea are at higher risk of developing hypertension, heart failure and stroke,” said Meir Kryger, director of Sleep Medicine Research and Education at Gaylord Hospital in New Haven, Connecticut. “There is a growing need for new treatment options for those patients who are non-compliant with current therapies.”
Inspire also announced today that it has received CE Mark for Inspire Upper Airway Stimulation therapy. “The receipt of the CE Mark is an important validation of our internal quality system and it authorises the commercial sale of Inspire therapy in Europe,” said Herbert. “The company’s current focus is to conduct a robust pivotal trial. We will begin initial European market development activities in late 2011.”
Leading medical centres in Germany, Belgium and The Netherlands are currently approved to implant patients into the STAR trial. Paul Van de Heyning, director of Otolaryngology and Head and Neck Surgery at the University of Antwerp, Belgium, recently implanted the first patient in the STAR trial. “Inspire’s stimulation therapy is well suited to address the root cause of obstructive sleep apnea for many patients which is a decrease in airway muscle tone during sleep,” said Professor Van de Heyning. “The Inspire implant procedure is less invasive than most obstructive sleep apnea surgical techniques which will likely contribute to faster patient recovery times. The STAR trial will provide valuable information on the potential role of upper airway stimulation therapy.”
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 US, Europe and Israel. Clinical data from those studies served as the basis for initiating the STAR trial.