What Is ITB Therapy?

ITB Therapy^SM (Intrathecal Baclofen Therapy), or the Medtronic baclofen pump, is a treatment that may relieve some of the symptoms of severe spasticity. Since 1992, more than 60,000 Medtronic baclofen pumps have been used worldwide to manage severe spasticity related to a variety of conditions.

Depending on your specific condition, ITB Therapy may impact your severe spasticity in different ways. Treatment may be even more effective when used in combination with physical or occupational therapy.

Detail - Pump and catheter placement

How ITB Therapy Treats Severe Spasticity

ITB Therapy uses a surgically implanted programmable pump and catheter that delivers medication which helps relieve severe spasticity. This medication is a liquid form of baclofen, called Lioresal^® Intrathecal (baclofen injection), that goes directly into the intrathecal space where fluid flows around the spinal cord.

Because Lioresal Intrathecal is delivered directly to where it’s needed most in the spinal fluid, it relieves spasticity with smaller amounts of medication than when baclofen is taken orally. This method of delivery may help minimize side effects that can result from oral baclofen.

Therapy Components

The ITB Therapy system consists of:

Pump – a surgically placed, battery-powered programmable pump with a reservoir infuses the drug at a programmed rate via the catheter
Catheter – a flexible silicone tube delivers medication from the pump to your body
Lioresal Intrathecal – a liquid form of the medication baclofen

Why Choose a Medtronic Pump System?

Medtronic has more intrathecal therapy experience than any other company
Medtronic ITB Therapy is the only intrathecal therapy backed by 20 years of experience in severe spasticity management
More than 60,000 pumps have been implanted worldwide for Medtronic ITB Therapy
The quality, reliability, and strength of the new Medtronic Ascenda™ catheter may reduce complications caused by kinks, breaks, and leaks – even during active daily living
Medtronic is a global company, so your system can be programmed and refilled in clinics across the United States and around the world
For more than 15 years, Medtronic has collaborated with advocacy groups to help raise awareness of spasticity and the conditions that can cause it

Next: SynchroMed II Pump

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: 8 Oct 2012