ImThera Medical has announced that the final patient has been implanted in its Targeted hypoglossal neurostimulation #2 (THN2) study. The THN2 Study is an international, prospective multicentre study that will evaluate the safety and efficacy of the Aura6000 sleep therapy system for the treatment of moderate to severe obstructive sleep apnoea.
This announcement was made as clinical and surgical leaders convened this week at the American Academy of Otolaryngology AAO-HNSF Meeting in Vancouver, Canada.
“We are excited to be the first USA centre to implant subjects in this landmark clinical study,” said Michael Friedman, professor of Otolaryngology and chairman Sleep Surgery Section at Rush University Medical Center, Chicago, and a study investigator. “The surgeries were simple to perform and took under 60 minutes. Patient satisfaction with the therapy is high and early results are very promising.”
The study enrolled 57 subjects at nine medical centres in five countries, including the USA. “There are literally millions of patients who have been diagnosed with obstructive sleep apnoea who are going untreated or undertreated because they are unable to comply with the rigours of continuous positive airway pressure therapy,” said Ofer Jacobowitz, a study investigator and partner at ENT and Allergy Associates in New York, USA. “We believe that this study will add to the growing body of clinical evidence demonstrating that the Aura6000 System is a viable treatment option for this large, underserved patient population.”
While obstructive sleep apnoea is readily treated with continuous positive airway pressure therapy, studies show that this therapy is cumbersome and that between 20–80% of patients cannot or will not comply with it. The Aura6000 System is an investigational device, limited by United States law to investigational use.