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Intrathecal Baclofen Therapy

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Full Prescribing Information
  • SynchroMed II

    View all ITB products

    Manuals and Technical Resources

    SynchroMed IsoMed Information for Prescribers

    This document includes information about contraindications, adverse events, component disposal, and other information regarding Medtronic SynchroMed® and IsoMed® infusion systems.

    Lioresal Intrathecal (baclofen injection) Full Prescribing Information

    This is the package insert for Lioresal® Intrathecal (baclofen injection).

    SynchroMed II Model 8637 Implant Manual

    This manual provides instructions for using for the SynchroMed II programmable infusion system model 8637.

    Indications, Drug Stability and Emergency Procedures Reference Manual

    This reference manual contains information specifically regarding indications, drug stability, and emergency procedures for the SynchroMed and IsoMed infusion systems.

    SynchroMed II Programming Guide

    This programming guide provides SynchroMed II pump model 8637 programming instructions for the software application card model 8870 software version B, using the N'Vision clinician programmer.

    SynchroMed Programmable Infusion Systems Clinical Reference Guide

    The seven chapters of the SynchroMed Programmable Infusion Systems Clinical Reference Guide offer in-depth information on various aspects of this programmable pump, used for the management of chronic pain and severe spasticity. The chapters include Intrathecal Morphine for Intractable Chronic Pain Management, Intrathecal Baclofen Therapy for Severe Spasticity Management, Surgical Procedures, Therapy Maintenance, Programming, System Components, and myPTM Personal Therapy Manager.

    ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.

    Important Safety Information for ITB Therapy: Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

    Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information.

     

    This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

    The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.

    The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

    Please refer to the full prescribing information and system information for details or call Medtronic at (800) 328-0810.

    USA Rx Only   Rev 0313

    United States