SAN DIEGO--(BUSINESS WIRE)--ImThera Medical Inc. today announced European CE Mark (Conformité Européenne) approval of its aura6000™ system for the treatment of obstructive sleep apnea (OSA).
The aura6000 system delivers mild electrical pulses to stimulate targeted muscles of the tongue during sleep, operating as a pacemaker for the tongue. The system uses ImThera Medical’s patented Targeted Hypoglossal Neurostimulation (THN Sleep Therapy™) method to focus neurostimulation on certain muscles of the tongue during sleep.
“The aura6000 is a new therapeutic option that has proven efficient in obstructive sleep apnea patients who cannot comply with CPAP,” said Professor Daniel Rodenstein, Department of Pneumology at Université Catholique de Louvain, St. Luc Hospital, (Belgium) and principal investigator of the ImThera study. “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.”
The aura6000 system consists of an 11 cm3 rechargeable neurostimulator—among the world’s smallest—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. Patients use a remote control and charger (RCC) to turn the system on/off and to recharge the neurostimulator.
"We are pleased to have reached this milestone and look forward to making this therapy available to patients at key European centers of excellence in the second half of 2012," said Marcelo G. Lima, Chairman, President and CEO of ImThera Medical. "This new therapy will prove to be an important tool for physicians to consider for the treatment of OSA." The limited launch of these systems in Europe represents ImThera Medical’s first commercial efforts.
The prevalence of obstructive sleep apnea syndrome has been extensively studied in recent decades and it has been estimated that between 1% and over 6% of the adult population (World Health Organization) suffers from obstructive sleep apnea. Approximately 20% of OSA patients in the first world have the benefit of some type of treatment. Continuous positive airway pressure (CPAP) is the established therapy for moderate to severe OSA, however studies show that only 54% of patients are able to comply to this method. Left untreated, OSA may lead to many serious consequences, including: hypertension, congestive heart failure, atrial fibrillation, stroke, type II diabetes, weight gain, depression and traffic accidents.
About ImThera Medical, Inc (www.imtheramedical.com) and THN Sleep Therapy
ImThera Medical has developed a novel neurostimulation system for the treatment of OSA. The aura6000™ system delivers the THN Sleep Therapy via a multi-contact electrode array that targets stimulation to subsets of the hypoglossal nerve to increase muscle tone in key tongue muscles during sleep, thereby opening the upper airway and treating OSA. In addition, the aura6000™ neurostimulator automatically cycles stimulation between several tongue muscles to prevent fatiguing any single muscle.
ImThera’s mission is to provide a safe and effective alternative for OSA patients who cannot comply with CPAP so that they can live longer and enjoy better lives, while substantially reducing health care costs related to the serious complications associated with untreated obstructive sleep apnea.
CAUTION: The aura6000TM is not for sale in the U.S.A.