Getting ITB Therapy

The Medtronic SynchroMed^® pump is a programmable device that delivers powerful medication around the clock, directly where it can have the biggest impact on your severe spasticity. If you successfully complete the screening test, then expect a 2-hour procedure and a stay in the hospital, if advised by your doctor, to have your pump placed.

Evaluation and Screening Test

Your doctor will consider many factors including your symptoms, goals, body mass, and results of a screening test.
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Your Healthcare Team

With Medtronic ITB Therapy^SM (Intrathecal Baclofen Therapy), also known as the baclofen pump, a variety of healthcare providers will work together to help manage your severe spasticity.
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Insurance Coverage

Medtronic ITB Therapy is an FDA-approved, commercially available treatment. It's covered for the approved indications by most health insurance companies, Medicare, and state Medicaid programs.
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Surgery: What to Expect

On average, the surgery to implant ITB Therapy takes about 1 to 2 hours from start to finish. Your doctor can answer any questions you may have about the procedure.
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Questions and Answers

We've provided answers to some of the common questions and concerns about how ITB Therapy can help you minimize the symptoms of severe spasticity.
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Personal Stories

Read about the experiences of people who have received our products and therapies. You’ll learn first-hand what life was like for these particular individuals, both before and after treatment.
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Next: Evaluation and Screening Test

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION ON ITB THERAPY

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.

The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia, seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal^® is a registered trademark of Medtronic, Inc.

USA Rx Only Rev 0911

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 4 Oct 2012