The European Commission has granted CE mark approval for ImThera Medical's aura6000 system, designed for the treatment of obstructive sleep apnoea (OSA).
The aura6000 system employs the company's patented Targeted Hypoglossal Neurostimulation (THN Sleep Therapy) method to deliver mild electrical pulses for the stimulation of targeted muscles of the tongue during sleep.
The aura6000 system consists of an 11cm3 rechargeable neurostimulator that generates electrical pulses and a lead (wire) with multiple electrodes that delivers the pulses to the hypoglossal nerve, which controls all muscles of the tongue.
The pilot study of the system, conducted at Université Catholiqu de Louvain in Belgium, indicated that all the ten patients included in the trial responded well to targeted hypoglossal neurostimulation therapy, while using the device every night at home. In a pre-defined subgroup, seven of ten patients showed a mean apnoea hypopnoea index (AHI) reduction of 68%, oxygen desaturation index (ODI) reduction of 68.1%, and HI reduction of 64.1%.
St. Luc Hospital, Belgium, Université Catholiqu de Louvain department of pneumology professor Daniel Rodenstein said the aura6000 is a new therapeutic option which has proven efficient in obstructive sleep apnoea patients who were non-compliant with continuous positive airway pressure (CPAP).
"Patients that tried and failed CPAP and then were implanted with the aura6000 tell me that this therapy has allowed them to recover freedom to sleep undisturbed and to resume a normal life," Rodenstein added.
ImThera Medical chairman president and CEO Marcelo Lima said: "We are pleased to have reached this milestone and look forward to making this therapy available to patients at key European centres of excellence in the second half of 2012."
The aim of the company is to provide a safe and effective alternative for OSA patients who cannot comply with CPAP, while substantially reducing healthcare costs related to serious complications associated with untreated OSA.