Tongue Stimulation Device Treats Obstructive Sleep Apnea

During sleep, the small (11 cm3) multicontact electrode array targets stimulation to subsets of the hypoglossal nerve to increase muscle tone in key tongue muscles, thereby opening the upper airway and treating OSA. In addition, the neurostimulator automatically cycles stimulation between several tongue muscles to prevent fatiguing any single muscle.

The system is composed of an implantable pulse generator (IPG) enclosure that contains the electronics and the radio frequency (RF) receive-transmit antenna; it is externally programmable, specifically set for each patient, and rechargeable. The external component includes the patient’s controller, charger, and a programmer device that interfaces to the IPG for both patient functions and set-up and programming, and includes the aura6000 Clinical Manager software. Using a paired remote control, patients can turn the device on and off, as well as wirelessly recharge it as necessary. The ImThera aura6000 OSA system is a product of ImThera Medical (San Diego, CA, USA), and has received the European Community CE marking of approval.

“The aura6000 is a new therapeutic option that has proven efficient in obstructive sleep apnea patients who cannot comply with CPAP,” said Prof. Daniel Rodenstein, MD, of the department of pneumology at Universite Catholique de Louvain (Belgium), and principal investigator of the ImThera clinical trial. “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 prevalence of OSA has been extensively studied in recent decades and the World Health Organization (WHO) estimates that 1%-6% of the adult population suffers from the syndrome. If left untreated, OSA may lead to serious consequences, including hypertension, congestive heart failure (CHF), atrial fibrillation (AF), stroke, type II diabetes, weight gain, depression, and traffic accidents. Approximately 20% of OSA patients in the first world have the benefit of some type of treatment, with continuous positive airway pressure (CPAP) as the established therapy for moderate to severe OSA; however, only 54% of patients are able to comply with this method.

Related Links:
ImThera Medical
Universite Catholique de Louvain