ImThera Medical, Inc. unveils its new product, the aura6000™ neurostimulation system for the treatment of Obstructive Sleep Apnea (OSA). According to the company, more than 800,000 patients in the US are annually diagnosed with OSA.
While Continuous Positive Airway Pressure (CPAP) is the established therapy, studies show that only 54 percent of patients comply with CPAP. The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™ delivering neurostimulation to the tongue during sleep. Additional features include:
- A surgically-placed multi-contact electrode specifically designed for the Hypoglossal nerve.
- A wire (lead) that connects the electrode to a programmable implantable pulse generator (IPG) that is placed in the anterior chest wall.
- The ability to deliver muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep.
- External programmability, specifically for each patient.
- External components including a patient’s controller/charger and a physician’s notebook PC which includes the aura6000 Clinical Manager THN Sleep Therapy physician software.
- The ability to targeting multiple tongue muscles to deliver therapy; operating in open loop, continuous mode during sleep, not requiring complex trigger (closed loop) methods and sensors.
- A multi-current source design, measuring just over 11 cubic centimeters in volume.
ImThera is exploring additional European clinical trial sites. The company will at a later date determine interest in the US in participating in US clinical trials once appropriate approvals have been obtained. ImThera’s device is not for sale in the U.S.A
For more information, visit www.imtheramedical.com