Dec 072010

Obstructive sleep apnea (OSA) is a condition in which breathing is periodically obstructed during sleep, often due to a prolapsed tongue or swollen throat. OSA affects 3-5% of people (18 millions in the US alone) and is often associated with obesity and old age. The hypoglossal nerve (HGN) controls the tongue and soft palate muscles. The closed-loop HGN stimulation, synchronized with the inspiratory phase of respiration, was shown (by Johns Hopkins U. researchers in mid-90es) to reduce the severity of OSA. In 1996-1997, Medtronic Inc. tested the first implantable HGN stimulator, Inspire I, in humans but soon abandoned the device due to concerns about its safety. Fast-forward to 2010: we have an expired patent on the HGN stimulation and several companies vying for dominance in this lucrative market. Charging ahead of the competition is a Medtronic’s spinout Inspire Medical Systems, with its device, Inspire II, that just received the CE Mark for clinical use in Europe. Not far behind are the Apnex Medical and ImThera Medical, who are undergoing clinical trials for their versions of the HGN stimulation devices. It is worth mentioning that other neurostimulation technologies are being applied for sleep apnea. Cardiac Concepts Inc. is developing a device for the phrenic nerve stimulation to restore a more natural breathing pattern in patients with the central sleep apnea, a related medical condition. Inspiration Medical Inc. holds several patents for the diaphragm pacing as yet another method for OSA treatment. Finally, there are some less-invasive approaches including tongue stimulation with sublingual electrodes and the repelling magnetic implants in the tongue base and posterolateral pharynx. Perhaps, it is too early to predict which of the technologies will ultimately prevail, so let’s not lose our sleep over this for now.

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