December 1, 2009 – ImThera Medical, Inc. announced that two patients have been surgically implanted with ImThera’s aura6000™ neurostimulation device for treating tongue‐based Obstructive Sleep Apnea (OSA).Patients are being enrolled in ImThera’s pilot clinical investigation in Belgium with the first results expected to be published in the first half of 2010. The patients were implanted with the aura6000, during which the hypoglossal nerve was briefly stimulated to verify system and nerve integrity. One week postsurgery, the patients underwent an in‐laboratory Polysomnography (PSG) titration process during which stimulation parameters were determined in order to maintain proper tongue position and to provide an open airway during sleep.
“The surgical procedures went smoothly, taking approximately 90 minutes to complete. There were no surgical complications; minor surgical issues were quickly resolved. At one week, patients were not disturbed by the implanted stimulator, lead or electrode,”...[PDF] ImThera Medical's Press Release -
