FDA OKs First Neurostimulator Implant for Sleep Apnea
Posted on May 2, 2014
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, according to Medscape Medical News.
The device, called Inspire Upper Airway Stimulationtherapy, is manufactured by Inspire Medical Systems, which announced the FDA's decision May 1.
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.
In February, the neurostimulator received a near unanimous voteof confidence in terms of safety and effectiveness from the Anesthesiology and Respiratory Therapy Devices Panel of the FDA's Medical Devices Advisory Committee.
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.
Source: Medscape Medical News