The FDA has approved an upper airway stimulation device to treat a subset of obstructive sleep apnea (OSA) when standard therapy isn't an option, device maker Thursday.
The neurostimulation device gained an indication for treating moderate-to-severe OSA (Apnea Hypopnea Index of 20 to 65 events per hour) in adults confirmed to have failed or not tolerated conventional continuous positive airway pressure (CPAP) treatment, largely following the recommendation of an FDA advisory panel in February.
Also, the patient anatomy has to be such that it wouldn't make stimulation ineffective, particularly complete concentric collapse at the level of the soft palate.
That panel suggested contraindications in a large portion of sleep apnea patients -- the obese, those with central and mixed apneas, and those with other implantable devices -- but those were not included in the final approval.
The pacemaker-like implant in the chest sends a mild electrical jolt down a lead to the hypoglossal nerve at the base of the tongue, moving the tongue to clear the airway. A lead in the chest senses when to send the pulse in the breathing cycle.
This was the first such device to be approved for OSA, although others are in development.
An uncontrolled open-label trial had shown a drop in apnea-hypopnea index by 68% with the device, from a median 29.3 events per hour before implantation to nine after 1 year of use (P<0.001), and a similar 70% reduction in oxygen desaturation index score.