Device to treat sleep apnea by ImThera in clinical trials

aura6000, a device to treat obstructive sleep apnea (OSA) developed by ImThera, is currently undergoing clinical trials in Belgium.

aura6000 is a Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy, which is aimed at treating Obstructive Sleep Apnea (OSA).

Targeted Hypoglossal Neurostimulation Sleep Therapy delivering neurostimulation to the tongue during sleep.

The system is comprised of a surgically?placed multi?contact electrode specifically designed for the hypoglossal nerve, and a wire (lead) that connects the electrode to a programmable implantable pulse generator (IPG) that is placed in the anterior chest wall.

The device delivers muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep.

The system is externally programmable, specifically for each patient, and rechargeable.

External components include a patient’s controller/charger and a physician’s notebook PC which includes the aura6000 Clinical Manager THN Sleep Therapy physician software. Targeting multiple tongue muscles to deliver therapy.

It operates in open loop, continuous mode during sleep, not requiring complex trigger (closed loop) methods and sensors.

The aura6000’s IPG is a multi?current source design and measures just over 11 cubic centimeters in volume.

More than 800,000 patients in the US are annually diagnosed with OSA. While Continuous Positive Airway Pressure (CPAP) remains as the established therapy, studies show that up to 50% of patients do not comply with CPAP.

“OSA is a serious health issue worldwide. With numerous OSA patients still lacking an effective treatment, other methods such as surgical therapies that specifically target the tongue are evolving and may become very compelling,” stated Marcelo G.Lima, chairman, president and CEO of ImThera Medical.

What is obstructive sleep apnea (OSA)?

Obstructive sleep apnea (OSA) is caused by changes in the position of the tongue during sleep that result in the closure of the soft tissues at the rear of the throat.

Central sleep apnea is caused by the failure of the brain to send breathing control signals to the muscles responsible for breathing.

Mixed sleep apnea is a combination of both obstructive and central, and obstructive sleep apnea is the most prevalent of the three.

OSA is characterized by the complete obstruction of airway causing breathing to cease completely (apnea) or partially (hypopnea) for intervals ranging from seconds to minutes.

The human airway (at the level of the thorax) is lined by soft tissue, any collapse of its walls results in the closure of the airway which leads to insufficient oxygen intake, thereby interrupting one’s sleep (episodes or micro-arousals).

Obstructive sleep apnea is a potentially life-threatening disease that often goes undiagnosed in most patients affected by sleep apnea.

The severity of sleep apnea is determined by dividing the number of episodes of apneas and hypopneas lasting ten seconds or more by the number of hours of sleep. The resulting number is called the apnea-hypopnea Index, or AHI.

ImThera’s device is not approved for sale in the USA.

Based in San Diego, ImThera Medical is a privately funded, early?stage company developing a patent?pending, neurostimulation medical device for the treatment of Obstructive Sleep Apnea (OSA).This innovative technology is designed to increase airway flow, permitting normal and restful sleep for OSA patients.