Obstructive Sleep apnea (OSA) is caused by complete or partial obstruction of the upper airway and the condition is characterized by repetitive episodes of shallow and paused breathing during sleep, despite the effort to breathe, and is usually associated with a reduction in blood oxygen saturation. Traditionally, continuous positive airway pressure (CPAP) device is the therapy that is used as a treatment for this condition.
However, for some, CPAP can result in many sleep destructions including unwanted noise, mask irritation, pressure intolerance, nasal congestion, claustrophobia, dry mouth and many more. It is estimated that more than 40% of patients refuse to wear it. Hence, companies are now coming up with advanced implantable devices, in which stimulation is used to open key airway muscles throughout the night. These implant systems are controlled by a remote or wearable patch, and generally the implant system include a breathing sensor and a stimulation lead powered by a small battery.
The system senses breathing patterns during the sleep and deliver mild stimulation to the tongue and throat to keep the airway open. Surgery to implant these devices are minimally invasive and requires short recovery time. ImThera Medical has created one such novel therapy, known as Targeted Hypoglossal Neurostimulation (THN).
The therapy is composed of pulse generator also known as pacemaker that is implanted in the upper part of the chest a small electrode attached to the pacemaker and positioned to interact with the hypoglossal nerve (also implanted), and an external remote control to activate the therapy. The neurostimulation implant will stimulate the activity of the hypoglossal nerve, which supports the activity of the tongue and improves the muscle tone in the tongue as well as the tone of the soft tissues adjacent to it.
The company is not only the first developer to bring a neurostimulation technology but in the past, Inspire Medical Systems launched a similar device in May 2014 using their patented Upper Airway Stimulation (UAS) therapy to treat OSA. Even other companies like Respicardia is developing a transvenous neurostimulation therapy, remedē System that specifically targets those patients with central sleep apnea. ImThera’s THN therapy is being tested for efficacy and is considered “under investigation” by the Food and Drug Administration, which in 2014 approved clinical trials for the device.