Indications And Contraindications

Contraindications for the use of Inspire® implant include the following:

• Central + mixed apneas >25% of the total apnea-hypopnea index (AHI)

• Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate

• Any condition or procedure that has compromised neurological control of the upper airway

• Patients who are unable or do not have the necessary assistance to operate the sleep remote

• Patients who are pregnant or plan to become pregnant

• Patients with Inspire Model 3024 cannot undergo MRI.

• Patients with Inspire Model 3028 or Model 3150 can undergo MRI if certain conditions and precautions are met. Please see the “MRI Guidelines for Inspire Implant” manual for more information.

• Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system. Consult the device manufacturer to assess the possibility of interaction

Possible adverse effects include, but are not limited to, the following patient related conditions:

• Damage to blood vessels in the vicinity of implant

• Excessive bleeding

• Nerve trauma or damage

• Allergic and/or rejection response to the implanted materials
  Infection

• Local irritation, seroma, hematoma, erosion, or swelling

• Persistent pain, numbness, or inflammation at the implant site

• Discomfort from the stimulation

• Tongue movement restrictions, irritation resulting from tongue abrasions on preexisting sharp or broken teeth

• Tongue soreness or weakness

• Problems with swallowing or speaking

• Undesirable change in stimulation over time, possibly related to tissue changes around the electrode(s), shifts in electrode position, loose electrical connections, or lead fractures

• Fibrosis to the extent that it makes it difficult to remove the system without damaging surrounding structures

• Dry mouth

• Other acute symptoms (ie, headaches, coughing, choking, dysphasia, and speech related events)

• Insomnia

• Pneumothorax

• Rhabdomyolysis

• Training – Physician must be trained in the proper use and surgical procedure before implantation or operation of the device.

• Pediatrics – The majority of cases of obstructive sleep apnea in younger pediatric patients (eg, less than 18 years of age) result from anatomical obstruction (eg, adenotonsillar hypertrophy) that would not be appropriately managed with neurostimulation implant.

• Components – The use of components not provided by Inspire Medical Systems may result in damaged components, improper operation, or increased risks to the patient.

• Diathermy – Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Diathermy can also damage the neurostimulation system components, resulting in loss of implant and requiring additional surgery for system explanation and replacement. Advise your patient to inform all their health care professionals that they should not be exposed to diathermy treatment. Injury to the patient or damage to the device can occur during diathermy treatment when:

  • The neurostimulation system is turned on or off

  • Diathermy is used anywhere on the body, not just at the location of the neurostimulation system

  • Diathermy delivers heat or no heat

  • Any component of the neurostimulation system (lead, extension, neurostimulator) remains in the body

• Magnetic Resonance Imaging –

  • The use of magnetic resonance imaging (MRI) on patients with Inspire Model 3024 is contraindicated. Patients with Inspire Model 3024 should not undergo MRI as it can cause tissue damage as well as damage to the Inspire system and components.
    Patients with Inspire Model 3028 or Model 3150 can undergo MRI if certain conditions and precautions are met. Please see the “MRI Guidelines for Inspire Implant” manual for more information.

  • Sleep Remote Use – When operating their sleep remote, patients should use special care near flammable or explosive atmospheres. An interaction between the flammable or explosive atmospheres and the battery in the sleep remote could occur. The consequences of using the battery-powered sleep remote near flammable or explosive atmospheres are unknown.

• Body Mass Index (BMI) — Data on BMI > 40 was not studied on a significant number of
patients in post-market registries and clinical trials. Safety and effectiveness of Inspire UAS for the BMI>40 patient population is unknown at this time.



  • Pediatric patients with Down syndrome and a BMI over the 95th percentile on the Centers for Disease Control and Prevention neurotypical growth curves have not been studied.

• Caution: Federal law (USA) restricts this device to sale by or on the order of a doctor. For more complete product information, please refer to the System Implant Manual that accompanies each system, or is available upon request from Inspire.