About Multiple Sclerosis
Multiple sclerosis is a central nervous system disease that affects millions worldwide. Although most individuals do not become severely disabled, more than half experience spasticity, which tightens muscles and can complicate daily life. Medtronic developed a unique technology to help control severe spasticity in some individuals.
Of the estimated 400,000 people in the United States and 2.5 million worldwide with multiple sclerosis,1 over half suffer from spasticity.2 If you experience severe spasticity connected to your multiple sclerosis, and respond positively to a screening test, our treatment may be able to reduce your spasticity.
Multiple sclerosis is a chronic, often disabling disease of the central nervous system (the brain or spinal cord).
Symptoms result when myelin, the protective insulation surrounding the nerve fibers of the central nervous system, is destroyed and replaced by scars of hardened "sclerotic" patches of tissue.1
Multiple sclerosis is most common in Caucasians (especially with Northern European ancestry), women, and individuals with a genetic predisposition. Studies indicate that genetic factors could make certain individuals more susceptible to the disease, but there is no evidence that MS is directly inherited.1
The symptoms of multiple sclerosis can be unpredictable and vary widely from person to person.
- 17% reported that spasticity frequently affects activities
- 13% reported a need to modify daily activities due to spasticity
- 4% reported that spasticity prevents daily activities
Types of Multiple Sclerosis
Your clinician may diagnose you with one of many different types of multiple sclerosis. Since 1996, multiple sclerosis has been categorized in the following ways:1
- Relapsing-Remitting (very common as initial diagnosis)
- Primary-Progressive (relatively rare)
- Secondary-Progressive (if left untreated, half of all Relapsing-Remitting individuals develop this within 10 years)
- Progressive-Relapsing (relatively rare)
About Spasticity due to Multiple Sclerosis
Spasticity is caused by damage or injury to the part of the central nervous system (the brain or spinal cord) that controls voluntary movement. This damage disrupts important signals between the nervous system and muscles, creating an imbalance that increases muscle activity or spasms.
Spasticity can make movement, posture, and balance difficult. It may affect your ability to move one or more of your limbs, or to move one side of your body. Sometimes spasticity is so severe that it gets in the way of daily activities, sleep patterns, and care giving. In certain situations, this loss of control can be dangerous for the individual.
- MS the Disease. National Multiple Sclerosis Society. www.nationalmssociety.org. Accessed October 30, 2012.
- Rizzo MA et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Multiple Sclerosis. 2004; 10: 589-95.
The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.
IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs 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 know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.
The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), 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. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. 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. You or your caregiver should 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 0913
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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.
- Find a Doctor
I'm exploring treatments for severe spasticity.
I have a baclofen pump or will soon.
Talk with someone who receives this therapy.