Important Safety Information

Inspire therapy is indicated for moderate to severe Obstructive Sleep Apnea in patients ages 18 years and older with an apnea-hypopnea index (AHI) between 15 and 65 and in pediatric Down syndrome patients ages 13 to 18 years with an AHI between 10 and 50. It should be used after you have tried positive airway pressure treatments and they have not worked, or you could not tolerate them.

Your doctor will need to evaluate your condition to determine if Inspire therapy is right for you. For example, Inspire therapy is not intended for patients with a complete concentric collapse at the level of the soft palate, or those in whom central and mixed apneas make up 25% or more of their apnea-hypopnea index. Patients who require MRI should discuss Inspire therapy with their doctor. In addition, Inspire therapy has not been clinically tested in patients with a body mass index greater than 32.

As with any surgically implanted device, there are risks associated with the Inspire system. First, there are risks related to the surgical procedure itself such as pain, swelling, temporary tongue weakness, and infection. These types of events are generally expected with any kind of surgery, and almost all of them are resolved on their own or with medication within a period of weeks or months. In rare cases tongue paresis and atrophy were observed.  Once the therapy is turned on, some patients may experience discomfort from stimulation, tongue abrasion, mouth dryness, and discomfort from the presence of the device. The majority of these events are resolved either on their own, with medication, or by adjusting the therapy settings. You will not be able to have diathermy if you have the Inspire system implanted. Inspire therapy may not work for everyone. Your doctor may need to take additional steps to address your sleep apnea. There are additional risks associated with removing your system.

This therapy is not for everyone. Please contact your doctor to decide whether Inspire therapy is right for you. For further information,
please call 1-844-OSA-HELP (1-844-672-4357) or click here to view Inspire Product Manuals.

800-341-001, Rev D