Two patients have been surgically implanted with ImThera Medical’s aura6000 neurostimulation device for treating tongue-based obstructive sleep apnea, according to information from the San Diego-based company.
During the implantation of the aura6000, the hypoglossal nerve was briefly stimulated to verify system and nerve integrity. One week post-surgery, the patients underwent an in-laboratory 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,” said Philippe Rombaux, MD, head of otolaryngology surgery at the Université Catholique de Louvain, Belgium.
“Speech, swallowing, and tongue sensibility were not disturbed by surgery. Stimulation resulted in effective and painless tongue movement during wakefulness. During sleep, stimulation at sufficient levels was not perceived by the patients and did not interrupt sleep. Although this was not at all an outcome planned for the analysis at one week after surgery, sleep apnea severity was improved during electrical stimulation. Clinical benefit can only be appreciated in the future, therefore we are looking forward to the results of this pilot study,” said principal investigator of the European study, Daniel Rodenstein, MD, PhD, also of the Université Catholique de Louvain.
According to information from ImThera, the physicians observed substantial improvement in upper airway opening and flow measured by normal sleep and a reduced AHI during the postsurgery PSG.
Currently, 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.
Listen to Sleep Review’s podcast with Marcelo G. Lima, chairman, president, and chief executive officer of ImThera Medical, as he discusses how the aura6000 works.