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Indications for Use

The remedē® System is indicated for transvenous phrenic nerve stimulation to treat central sleep apnea.

Contraindications

  • The remedē System is contraindicated for the following:
    • Patients with an active infection
    • Patents known to require magnetic resonance imaging (MRI)

Warnings

  • Diathermy – Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (collectively referred to as diathermy) on patients implanted with the remedē System. Energy produced by diathermy equipment may be transferred through the implanted system and can cause permanent tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Diathermy can also damage the remedē System, resulting in loss of therapy and requiring additional surgery for system explantation and replacement. Advise the patient to inform their health care professionals that diathermy exposure should be avoided.
  • Electric Shock – When operating under AC power, the remedē System Programmer must be connected to a grounded power source to avoid risk of electric shock.
  • Concomitant Active Implantable Devices – Use remedē System with caution in patients with an active implantable device that may be susceptible to unintended interaction with the remedē System.
  • Patients with Evidence of Phrenic Nerve Palsy – Therapy with the remedē System may be ineffective in patients who have evidence of phrenic nerve palsy.
  • Pediatric Use – The safety and effectiveness of the remedē System has not been established for pediatric use.
  • Magnetic Resonance Imaging (MRI or NMRI) – Do not use magnetic resonance imaging (MRI or NMRI) on patients who have been implanted with the remedē System. Energy produced by MRI equipment may result in permanent tissue damage or damage to the remedē System. Alternative imaging options should be considered.
  • Modified Components – The use of modified components with the remedē System is not allowed and may result in damaged components, unintended operation, or increased risks to the patient.
  • Pacemaker Dependence – Use remedē System therapy with caution in pacemaker dependent patients without a physiologic escape rhythm. Device interaction may lead to over or undersensing resulting in a loss of pacing.
  • Pregnancy -The safety and effectiveness of the remedē System during pregnancy has not been established.

Precautions

  • The remedē System is designed to ensure immunity from most common sources of electromagnetic interference (EMI). In most cases, turning off the EMI source, or moving away from the EMI source will return the IPG to normal operation. Extremely strong sources of EMI could interfere with normal IPG operation, causing the IPG to reset and requiring the programmed settings to be reconfigured. For information on MRI and diathermy, see ‘Warnings’ 
  • Electrocautery – Electrocautery may induce failure of the IPG and leads if direct contact is made. Alternatives to electrocautery should be used when available. If electrocautery is necessary, the remedē System should be programmed off and bipolar cautery should be used. Confirm proper function of the remedē System after any procedure where electrocautery is used.
  • Radiofrequency or Cryoballoon Ablation – If radiofrequency or cryoballoon ablation must be used in the vicinity of the IPG or leads, the remedē System should be programmed off. Avoid direct contact between the radiofrequency ablation or cryoballoon catheter and the implanted remedē System.
  • Therapeutic Radiation – The IPG should not be directly irradiated by therapeutic levels of ionizing radiation (such as that produced by cobalt machines or linear accelerators used for treatment of certain cancers) because of the risk for damage to the remedē System. If such therapy is required, program the remedē System off, shield the device, and confirm proper function of the remedē System after treatment.
  • Computed Tomography (CT) Imaging – If a CT scan is required, ensure that the remedē System is off and confirm proper function of the remedē System after the scan is complete.
  • Therapeutic Ultrasound – Exposure to high ultrasonic frequencies may result in damage to the remedē System. It is not recommended to use high-output ultrasonic devices, such as an electrohydraulic lithotripter or bone growth simulator on patients implanted with the remedē System. If therapeutic ultrasound must be performed, program the remedē System off and keep the implanted system a minimum of 2.5 cm (1 in) away from the ultrasonic field. Confirm proper function of the remedē System after treatment.
  • External Defibrillation Energy – The use of external defibrillation may cause damage to the remedē System. The risk of damage may be minimized by positioning the defibrillation patches or paddles a minimum of 15 cm (6 in) and perpendicular to the IPG. Confirm proper function of the remedē System after any use of external defibrillation.
  • Patient Monitoring Equipment – remedē System stimulation therapy may be detectable by patient monitoring equipment including automated external defibrillators. Confirm proper function of monitoring equipment if used while remedē stimulation therapy is active.
  • Transcutaneous Electrical Nerve Stimulators (TENS) – TENS therapy should be used only if the remedē System is inactive (not providing stimulation therapy). If TENS therapy must be used, place the TENS electrodes as far from the remedē System as possible. TENS electrodes should also be spaced as close together as possible to reduce the generated electrical field. Confirm proper function of the remedē System after use of TENS therapy.
  • Electrical Isolation During Implant – Do not allow the patient to have contact with grounded equipment that might produce electrical current leakage during implant. Electrical current leakage may induce arrhythmias that could result in patient death.
  • Lead Compatibility – Only use IS-1 lead or lead extension terminals with the remedē System. Use of non IS-1 compatible terminals may result in undersensing of respiratory activity, failure to deliver necessary therapy, or a leaking or intermittent electrical connection.
  • Concomitant Active Implantable Cardiac Devices – It is recommended that testing for oversensing of remedē stimulation therapy by the concomitant cardiac device occur at the time of implant and prior to initiating remedē System therapy in patients with a concomitantly implanted cardiac device (testing protocol described on page 36 on the device manual). Programming of the remedē System and/or the concomitant device, when necessary, can prevent oversensing of remedē stimulation therapy.
  • To avoid telemetry interference, one telemetric programming system should be utilized at a time if the concomitantly implanted device uses magnetic inductive telemetry.

Adverse Effects

Possible adverse events which may be associated with the implantation and use of the remedē System include, but are not limited to, the following: adverse contrast dye reaction such as allergic reaction, pulmonary edema, or worsening renal function, adverse reaction to radiation exposure, thromboembolism, air embolism, bleeding, cardiac perforation including tamponade, hematoma, seroma, local bruising or swelling, hypotension, local wound healing issues at device implant site including wound dehiscence, pocket erosion, extrusion, movement of implanted device, keloid formation, pneumothorax, hemothorax, vascular damage, e.g., venous dissection, perforation, adverse biocompatibility reaction to the implanted system, infection, lead breakage, lead dislodgement, lead not connected or secured appropriately in device header, implantable device malfunction, requirement for more energy to stimulate the nerve or ineffective stimulation, venous occlusion, crosstalk with another implanted device, disrupted sleep, muscle fatigue or discomfort in diaphragm, chest or abdomen from appropriate stimulation, nerve dysfunction, perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea, inappropriate sensations, worsening heart failure, respiratory status or overall health, anxiety, arrhythmia, including ventricular fibrillation, death, depression, hypotension, pain, skin irritation or local allergic reaction, thrombus or embolism, potentially leading to pulmonary embolism or stroke.

CAUTION: Rx only. Prior to use, please see the complete “System Implant and Clinician Use Manual” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.