The
US Food and Drug Administration (FDA) has approved the first fully implantable
neurostimulator to treat obstructive sleep apnea (OSA), but only as a
second-line therapy. The device, called Inspire
Upper Airway Stimulation therapy, is manufactured by Inspire Medical
Systems, which announced the FDA's decision today. The implant helps keep a
patient's airway open by stimulating the hypoglossal nerve during sleep in
tandem with a patient's inspiration. The stimulation contracts upper airway
muscles to pull the base of the tongue forward. The FDA has approved Inspire
Upper Airway Stimulation therapy specifically for patients with moderate to
severe OSA who cannot use continuous positive airway pressure. Adverse events
reported in a clinical trial of the device included tongue weakness, dry mouth,
pain, and numbness. The device is incompatible with having a magnetic resonance
imaging scan. Stimulating the hypoglossal nerve reduces the severity of
obstructive sleep apnea (OSA) and improves daytime sleepiness symptoms and
quality of life, authors of a new study report. These documented improvements
using standard pacemaker technology offer patients who are unable to tolerate
continuous positive airway pressure (CPAP) an alternative treatment In some
patients with obstructive sleep apnea, the pharyngeal dilator muscles are
ineffective. Soft tissues and craniofacial structures around the pharyngeal
airway may be compromised, leading to increased airway collapsibility. Prospective
study participants were screened using polysomnography and endoscopy performed
while patients were in a drug-induced sleep. During the endoscopy procedure,
investigators looked for signs of complete concentric collapse at the
retropalatal airway; patients with this sort of collapse were excluded from the
study because it's a predictor of nonresponse to stimulation.
