Intrathecal Baclofen Therapy

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Presentations

Note: all video files must reside in the same directory folder as the presentation in order to display properly.

This presentation includes information about the sutureless pump connector implant and technology.

Audio

This 40-minute audio file discusses the article by Dr. Terence Edgar,originally published in the January 2007 issue of Journal of Child Neurology.

Videos

This video illustrates the effect of ITB Therapy on Kaleigh living with severe spasticity due to cerebral palsy.

This video illustrates the effect of ITB Therapy on Nick who is living with severe spasticity due to cerebral palsy.

This video illustrates the effect of ITB Therapy on Kaleigh who is living with severe spasticity due to cerebral palsy.

This video provides patients with an overview of ITB TherapySM (Intrathecal Baclofen Therapy).

This video provides patients with an overview of ITB Therapy.

This video educates adult patients, families, and caregivers on the ITB Therapy screening test.

This video educates pediatrics and their caregivers on the ITB Therapy screening test.

This video shares Bob's experience with ITB Therapy. Bob struggles with severe spasticity due to multiple sclerosis.

This video shares Mary's experience with ITB Therapy. Mary struggles with severe spasticity due to stroke.

Images

Preview
Intrathecal Catheters 2
Lioresal Intrathecal
N'Vision Programmer
Pump Placement in Body
SynchroMed II Pump
SynchroMed II No Catheter

For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review the device brief summaries for the SynchroMed II Drug Infusion System and the SynchroMed EL Infusion System.

ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. 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.

Indications, Safety & Warnings 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).

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 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

January 2008