Indications/
Contraindications for Use

Inspire therapy is indicated for patients with the following characteristics:

  • 22 years of age or older
  • have moderate to severe OSA (AHI range from 15-65 with <25% central apneas)
  • unable to use CPAP
  • free of complete concentric collapse at the palate

Inspire therapy has not been tested in people with a BMI greater than 32.

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Specifically:
Inspire Upper Airway Stimulation (UAS) is used to treat a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA) (apnea-hypopnea index [AHI] of greater than or equal to 15 and less than or equal to 65). Inspire UAS is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level.

PAP failure is defined as an inability to eliminate OSA (AHI of greater than 15 despite PAP usage), and PAP intolerance is defined as:

  1. Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or
  2. Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).

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Contraindications

Contraindications for the use of Inspire UAS therapy 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 can undergo MRI on the head and extremities if certain conditions and precautions are met. Please see the “MRI Guidelines for Inspire Therapy” 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

Potential Adverse Events

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

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Warnings

  • Training – Doctors 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 therapy.
  • 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 therapy 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 can undergo MRI on the head and extremities if certain conditions and precautions are met. Please see the “MRI Guidelines for Inspire Therapy” 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) – BMI greater than 32 was not studied as part of the pivotal trial. Based on data from the feasibility study, it may be associated with decreased likelihood of response to treatment. Use of Inspire UAS in higher BMI patients is not recommended due to unknown effectiveness and safety.

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.

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