FDA approves first fully implantable device for obstructive sleep apnea

fda logo FDA approves first fully implantable device for obstructive sleep apnea Individuals with obstructive sleep apnea (OSA) who have unsuccessfully tried other remedies have a new treatment available. The Food and Drug Administration (FDA) announced it has approved the first fully implantable neurostimulator to treat the condition, but only as a second-line therapy.

Inspire Upper Airway Stimulation therapy, made by Inspire Medical Systems, is an implant that keeps a patient’s airway open during sleep by stimulating the hypoglossal nerve, causing the upper airway muscles to contract and pull the base of the tongue forward. The device was approved specifically for patients with moderate to severe OSA who cannot use continuous positive airway pressure.

Obstructive sleep apnea is a potentially serious sleep disorder in which breathing repeatedly stops and starts because the airway has become narrowed, blocked or floppy. Treatment generally involves using a device to keep their airway open or using a mouthpiece to thrust the jaw forward during sleep. Some people undergo surgery to change the structure of their nose, mouth or throat. Some devices are not comfortable or are not tolerated well by patients, making treatment difficult.

According to the company’s website, Inspire Upper Airway Stimulation therapy is an implanted system that consists of three components – a small pulse generator, a sensing lead, and a stimulation lead. The single external component, a small handheld Inspire sleep remote, turns the therapy on before bed and off upon waking.

When activated, Inspire therapy senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep. Unlike other surgical procedures to treat OSA, Inspire therapy does not require removing a patient’s facial or airway anatomy.

Adverse events with the neurostimulator included tongue weakness, dry mouth, pain and numbness. Also, the device is incompatible with having a magnetic resonance imaging (MRI) scan.