Safety Information

Indication for Use

The Genio system 2.1 is used to treat patients suffering from moderate to severe Obstructive Sleep Apnea (OSA), defined as AHI of greater or equal to 15 and less than or equal to 65, with and without Complete Concentric Collapse (CCC) at the soft palate level.

The Genio system 2.1 is used in adult patients who have not tolerated, have failed or refused PAP treatments.
PAP failure is defined as the inability to eliminate OSA (AHI of greater than 15 despite PAP usage).
PAP intolerance is defined as the inability to use PAP (less than 5 nights per week of usage; usage defined as 4 hours or more of use per night) or the unwillingness to continue to use PAP (after attempting to use it).

Contraindications

The Genio system 2.1 is contraindicated for:

  • Children.
  • Patients with an Apnea-Hypopnea Index below 15 or over 65 events/hour.
  • Patients with combined central and mixed Apnea-Hypopnea Index > 25% of the total AHI.
  • Pregnant women, or women planning to become pregnant.
  • Patients with any functional or structural problem that would impair the ability of a hypoglossal nerve stimulator to treat OSA.
  • Patients with any medical illness or condition that contraindicates a surgical procedure under general anesthesia or that would prevent the implantation of the Implantable Stimulator or the placement of Activation Chip/Disposable Patch.
  • Patients with coagulopathy or requiring anticoagulant medications (such as warfarin, Clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period.
  • Patients with major head and neck abnormalities narrowing the airway or the implantation site.
  • Patients with hypersensitivity to any material of system components.
  • Patients with other Active Implantable Medical Devices (AIMD).

Warnings

Pediatric Use

Safety and effectiveness of the use of the Genio system 2.1 has not been established in children.

Components

The use of charging adaptors not provided by Nyxoah may result in device malfunction, damaged devices or increase the risks to the users.

Body Mass Index (BMI)

Patients with a body mass index (BMI) equal to or lower than 32 kg/m2 have been investigated in clinical studies with this device. The use of the Genio system 2.1 in patients with higher BMI (> 32 kg/m2) has not been investigated.

MRI Safety Information

This section contains important information regarding the Genio® Implantable Stimulator (IS) and the conditions in which an MRI scan can be safely performed.

The Genio IS is a Magnetic Resonance (MR) Conditional device marked by the symbol MR inside a yellow triange which means that under MR environment the implant is safe within certain conditions.

MRI Scan Conditions, MRI Technician warnings and precautions are listed in the Genio system 2.1 Patient Instructions for Use (Section 2 – Safety Information).

MRI scans must be performed only as described in this section.

If MRI scan was instructed, read the information in this section and the Genio system 2.1 Patient Instructions for Use.

It is important to share the information and discuss it with the treating physician and MRI technician.

Bring Genio system 2.1 Patient Instructions for Use and implant identification card to the MRI scan appointment.

Potential Risks Associated With MRI Scans

The Genio IS device has been designed to minimize the potential adverse events that could result in patient harm.

The potential MRI-related adverse events are listed below:

  • Implant heating causing damage to tissue in contact with the implant.
  • Implant migration causing damage to tissue in contact with the implant.
  • Implant migration causing the implant to be surgically removed (and replaced).
  • Unintended overstimulation causing damage to tissue in contact with the implant.
  • Unintended stimulation causing discomfort due to electrical stimulation.
  • Device malfunction causing the implant to be surgically removed (and replaced).
  • Diagnostic problems due to artifacts - shadowing on the MRI image in the vicinity of the implant causing loss or disturbance of diagnostic information.

MRI - Patient Warnings and Precautions

  • Do not bring the Genio system 2.1 external devices (such as the Genio Disposable Patch or Genio Activation Chip) with you to the MRI scan room. The use of the Genio Disposable Patch and Activation Chip during an MRI scan is prohibited.
  • Do not go through an MRI scan if you have a fever.
  • In case you feel uncomfortable pain or heating during the MRI scan, notify the MRI technician so that the scan can be stopped. Consult your treating physician to determine if anesthetics may be administered to reduce pain or discomfort.
  • The MRI scan should be conducted at least 6 weeks after your implantation or revision surgery. If you are required to undergo an MRI scan during this period, please consult your treating physician.
  • In case you experience a change in implant functionality please contact your treating physician.

Precautions

Pregnancy

  • There might be unknown risks to pregnancy if the implanted device is used while pregnant.
  • The the treating physician shall be informed in case of pregnancy or planned pregnancy.
  • In case of pregnancy after the implantation of the device, the device will need to be turned off as soon as possible. The device should remain OFF during pregnancy.

Defibrillation/Cardioversion

  • In case of a serious heart rhythm problem (such as ventricular or atrial fibrillation), in the time of device application, the Disposable Patch and the attached Activation Chip should be removed from the chin prior to the use of defibrillation or cardioversion.
  • After defibrillation or cardioversion, a doctor should confirm the Genio system 2.1 is working as intended.
  • Possible interaction between the Genio system 2.1 and cardiac devices (implantable defibrillators) has not been investigated.

Water and Humidity

  • It is advised to keep Genio external devices away from extremely humid areas and sources of water. Water and humidity may result in device malfunctions.

Medical Procedures

  • Medical staff should always be informed of implanted medical device in the chin area before any medical procedures or examinations.
  • The following medical procedures may interfere with the Genio system 2.1 or cause permanent damage to the implant or to the body tissue:
    • Treatment of muscle and joint conditions using heating of the tissue by high frequency electric current (diathermy).
    • Treating abnormal heartbeats with an internal or external defibrillation.
    • Radiation therapy.
    • Treating kidney stones with ultrasound (lithotripsy).
    • Magnetic stimulation, or any other form of electrical stimulation.
  • Treating doctor should be consulted prior to undergoing the above listed procedures.

Treatment with Therapeutic Ionizing Radiation

  • After the implantation of the Implantable Stimulator, treatment with therapeutic ionizing radiation should not be applied.
  • If radiation therapy is required in the area of the device, the Genio Implantable Stimulator might need to be surgically removed.
  • If radiation therapy is applied to an area far away from the implanted device, the device should be shielded, and its function confirmed after treatment.

Therapeutic Ultrasound

  • Before undergoing treatment with ultrasound therapy, the treating physician should be consulted as it might damage the Implantable Stimulator and/or might cause tissue damage.

Radio-Frequency or Microwave Ablation

  • No exposure to radio-frequency or microwave ablation is allowed. The electrical current may cause heating resulting in device and/or tissue damage.
  • If radio-frequency or microwave ablation is required in the area of the device, it might need to be surgically removed.

Hyperbaric Chambers

  • There may be possible safety hazards associated with hyperbaric chambers when the Implantable Stimulator is in place.
  • The effects of high pressure should be discussed with the treating physician before entering hyperbaric chambers.

Entering Special Areas

  • Before entering environments that are protected by a warning notice preventing entry by persons fitted with an Active Implantable Medical Device (AIMD) such as a pacemaker, refer to medical guidance.

Metal Detectors

  • Interactions with metal detectors are unlikely to damage the Implantable Stimulator or cause clinically significant symptoms. However, the Implantable Stimulator contains metal parts that might possibly set off metal detector alarms.
  • Inform security personnel of the implanted device in the chin area and always have the Implant Identification Card with you. Security wands should not affect the device.

Physical Activities and Sports

  • Use caution and consult the treating physician prior to performing activities that may damage or displace the Implantable Stimulator such as diving, boxing, jack-hammering, extreme sports etc.

Implant Identification Card

  • The Implant Identification Card supplies information about the Genio system 2.1 and treating physician contact information. It should be presented in case of a medical emergency or security requirements.
  • The Implant Identification Card should be carried on at all times!

Device Charging

  • The Activation Chip must be charged on a daily basis in order to be fully charged for the next night of use.

Cleaning your Devices

  • The devices should be kept in a clean environment.
  • The Activation Chip should be kept in the provided protective cover when it is not in use or not being charged.
  • Do not attempt to clean the devices.
  • If functionality is compromised due to lack of cleanliness, please contact your physician.

Adverse Events

  • Medical treatments often cause side effects. None, some or all the side effects listed below may be experienced in a mild, moderate or severe way.
  • In case of any side effects, or any questions, consult the treating physician.
  • Risks of using the Genio system 2.1 can be minimized by following the Instructions for Use, and by following doctor’s instructions.
  • In addition to the risks described below, the device may have other risks that are currently unknown. Immediately inform the treating physician or a member of his/her team if experiencing any side effects, or upon appearance of any other health issues.
  • If a severe side effect or reaction occurs, the treating physician may need to stop your therapy.

Risks Associated With the Implantation Procedure

  • For the purpose of device implantation, a surgery procedure under general anesthesia is required. Whilst anesthesia is generally very safe nowadays, there is always the possibility of some risks associated with anesthesia. The commonly known adverse events associated with anesthesia are listed below. Most of these anesthesia-related events are uncommon and are generally resolved quickly. The risk of brain damage or death due to anesthesia is very low.
  • The risk of complications from anesthesia increases for people who have frequent surgical procedures within a short timeframe and participants with other high-risk diseases.

The anesthesia and implantation surgery may involve the following risks:

Very common risks (which may affect more than 1 in 10 participants)
  • Post-surgical discomfort.
  • Post-surgical numbness, tingling or other sensory changes related to the skin incision.
  • Post-surgical mild to moderate swelling or bruising around the incision site.
  • Post-surgical mild to moderate pain, stiffness or tenderness at the incision site.
  • Impaired or painful swallowing.
  • Impaired or painful speaking due to the procedure.
  • Paraesthesia (sensation of tingling or itching).
  • Bleeding (including haematoma).
  • Abnormal scarring.
  • Pain or irritation in the throat or nasal passage from intubation.
  • Feeling unwell or vomiting.
  • Dry mouth.
  • Post-surgical hoarse voice due to anesthesia.
  • Bruising at the site of injections.
Common risks (which may affect between 1 in 10 and 1 in 100 participants)
  • Post-surgical headache, dizziness.
  • Damage or trauma to nerves, blood vessels or muscles.
  • Transient tongue weakness.
  • Local skin irritation.
  • Post-surgical diarrhea.
  • Tongue fasciculations (twitching of tongue).
  • Tongue muscle weakness or soreness.
  • Muscle or skin tightness.
  • Post-surgical back pain due to lying on the table during the procedure.
  • Infection.
Uncommon risks (which may affect less than 1 in 100 participants)
  • Temporary lip weakness.
  • Post-surgical fever.
  • Superficial skin infection.
  • Impaired sense of taste.
  • Tongue may get larger or smaller.
  • Persistent pain at the implant site.
  • Post-surgical irritability, nervousness, confusion.
  • Post-surgical sleep problems like insomnia or sleepiness.
  • Post-surgical respiratory complications requiring ventilation.
  • Aspiration (i.e. food/fluid directed to windpipe when swallowing).
  • Allergic reaction to anesthetics or other medications used before, during, or after the surgery.

Risks associated with the devices and the use of the devices

The potential device-related adverse events are listed below:

Very common risks (which may affect more than 1 in 10 participants)
  • Discomfort due to electrical stimulation.
  • Mild tongue abrasion.
  • Temporary local skin irritation.
  • Abnormal scarring.
  • Tongue fasciculations (twitching of tongue).
  • Paraesthesia (sensation of tickling or itching).
  • Impaired or painful swallowing due to the device.
Common risks (which may affect between 1 in 10 and 1 in 100 participants)
  • Dry mouth.
  • Temporary tongue muscle weakness or soreness.
  • Temporary usability or functionality issues with an external device leading to temporary delay of treatment.
  • Permanent usability or functionality issues with an external device leading to no therapy.
  • Usability or functionality issues with the implanted device.
  • Increased or continued snoring.
  • Mouth blisters (due to tongue rubbing against teeth during stimulation).
  • Pain or irritation in the throat or nasal passage.
  • Post-surgical mild to moderate pain, stiffness or tenderness at the incision site.
  • Implant may need to be surgically removed (and replaced).
  • Infection.
Uncommon risks (which may affect less than 1 in 100 participants)
  • Allergic and/or rejection response to the implanted device.
  • Damage to tissue in contact with the implant.
  • Damage to tissue in contact with external devices.
  • Persistent pain at the implant site.
  • Impaired or painful speaking due to the device.
  • Damage or trauma to blood vessels/nerves in the vicinity of the implant.
  • Clinically significant implant migration (device moving from implanted location).
  • Change in salivary flow.

Risks associated with a revision surgery

  • If an additional surgery is performed in order to have the implant removed or replaced, the risks associated with the implantation procedure detailed above, along with some new risks, would apply to the revision surgery.
  • The risks of a revision surgery are higher because scar tissue builds up around the implanted device.
  • The risk of infection from the surgery is slightly higher. Injury to nerves, blood vessels or tissues around the implanted device could occur.

Risks associated with sleep studies

  • The Polysomnography (PSG) is a non-invasive, painless test but may be uncomfortable. Complications are rare.
  • The most common side effects are as follows:
    • Being unable to sleep in the sleep lab causing tiredness or fatigue the next day and loss of productivity.
    • Local irritation or bleeding of the skin where external electrode sites are attached.
    • Bruising, bleeding or soreness from external electrode removal.

Risks associated with pregnancy

  • The general anesthesia performed for the implantation surgery may present risks for the embryo.
  • The effects of the Genio system 2.1 on the unborn child and on the new-born are not known.

Storage and Handling

  • External system components must be stored at a secure, cool and dry place.Transportation may be at -10 to 55°C.
  • Do NOT expose the products to direct sunlight.
  • Humidity — Keep your Genio external devices away from extremely humid areas and sources of water.
  • Expiration date — Disposable patches should not be used after the expiration date.Expiration date is indicated on component’s packaging labels.
  • Handling — The components of the Genio system 2.1 should be handled with care:
    • The Activation Chip metal pins at the bottom of the chip should not be in contact with any surface except for the Disposable Patch, the Charging Unit docking area or the Activation Chip protection cover.
    • The devices should not be placed on any metallic surfaces.
    • We recommend that you leave the Activation Chip in the Charging Unit all day to ensure it will be fully charged for the next night of use.
    • Make sure to close the zipper of the bag containing the new Disposable Patches, to avoid any moisture/humidity that may affect the adherence properties of the patches.
  • Traveling with the Devices — Be cautious when traveling with the devices.Follow the package and transport conditions of the different components:
    • Always transport the Activation Chip in its protective cover.
    • Do not fold the Disposable Patches before use.
    • Disconnect the Charging Unit from its adapter.
  • Disposal — Waste of Electrical and Electronic Equipment.

EMC Warnings

  • Use of Genio system 2.1 components should be observed to verify that they are operating normally.
  • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of Genio system 2.1 could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Genio system 2.1, including cables specified by the manufacturer. Otherwise, degradation of the performance could result.
  • The Genio system 2.1 needs special precautions regarding EMC and needs to be installed and put into service according to the specific instructions for maintaining basic safety and essential performance with regard to electromagnetic disturbances for the expected service life.

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Genio is a registered trademark of Nyxoah.

The Genio system is CE-marked as a medical device.