Obstructive Sleep Apnea (OSA) affects approximately 12 million people in the U.S. alone. Repeated episodes of apnea due to airway collapse can lead to daytime fatigue and increase a person’s risk for more severe complications, usually cardiac. Existing therapies for OSA include upper airway surgeries, oral devices, and continuous positive airway pressure (CPAP). While CPAP can be particularly effective in patients when used, it can be cumbersome with many patients failing to comply with treatment.
Inspire Medical Systems (Maple Grove, MN), has developed an implantable OSA therapy called Inspire. The system is an implanted upper airway stimulator unit, that looks like a pacemaker, designed to stimulate the hypoglossal nerve on each breathing cycle to prevent airway obstruction during sleep. During implantation a stimulation electrode is placed on the hypoglossal nerve, a sensing lead is placed between intercostal muscles to sense breathing patterns, and a neurostimulator is implanted just below the clavicle bone. Patients activate the device at night using an external controller.
The technology has its origins in the neurostimulation and cardiac pacing technology developed by Medtronic. In contrast to other surgical procedures to treat obstructive sleep apnea, Inspire therapy does not require removing or altering a patient’s facial or airway anatomy.
The technology is currently being evaluated in 22 medical centers in the United States and Europe as part of the multicenter, prospective Stimulation Therapy for Apnea Reduction (STAR) trial. Last week the first 12 month follow up results were published in the New England Journal Medicine. The device achieved a 70% reduction in the severity of sleep apnea episodes as well as a reduction in daytime sleepiness.
The Inspire Therapy is CE Marked and approved for sale in Europe and is currently undergoing review by the FDA.
Here’s Ryan Soose, M.D., director of the UPMC (University of Pittsburgh Medical Center) Division of Sleep Surgery and assistant professor at the University of Pittsburgh School of Medicine, explaining the device and trial:
Flashbacks: FDA OKs Trial for Inspire Medicals Implantable Nerve Stimulator For Sleep Apnea; Hypoglossal Nerve Stimulation System for Obstructive Sleep Apnea Receives CE Approval; ImThera’s Targeted Hypoglossal Neurostimulation Therapy for Obstructive Sleep Apnea
University of Pittsburgh School of Medicine: New Device Can Reduce Sleep Apnea Episodes by 70 Percent, Pitt-UPMC Study Shows…
Link: Inspire homepage…
