First Neurostimulator Implant for Sleep Apnea

Maria Dalamagka 

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.