Indications for Inspire® therapy
Inspire therapy is indicated for patients with the following characteristics*:
Adults
Diagnosed with moderate to severe OSA (AHI 15-100)
Unable to use or get consistent benefit from CPAP
Not significantly overweight
Pediatric patients with Down Syndrome
Aged 13-18
Diagnosed with Severe OSA (AHI 10-50)
Unable to use or get consistent benefit from CPAP
Not effectively treated by adenotonsillectomy.
*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 100). 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:
Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or
Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).
Inspire UAS is also indicated for OSA patients ages 18 to 21 years with moderate to severe OSA (15≤AHI≤100), and pediatric patients ages 13 to 18 years with Down Syndrome and severe sleep apnea (10<AHI<50) who:
Do not have complete concentric collapse at the soft palate level.
Are contraindicated for, or not effectively treated by, adenotonsillectomy
Have been confirmed to fail, or cannot tolerate, PAP implant despite attempts to improve compliance
Have followed standard of care in considering all other alternative/adjunct therapies
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 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
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
Pneumothorax
Rhabdomyolysis
Warnings
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 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.
Our therapy
Inspire therapy works inside the body. The small Inspire® implant is placed during a same-day, outpatient procedure. Once healed, the patient will use a small handheld Inspire™ remote to turn the therapy on and off. While asleep, the Inspire implant opens the patient’s airway, allowing them to breathe regularly and sleep soundly.