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      Cindy Resman

            Public Relations

                        763-526-6248

Severe Spasticity and Medtronic ITB Therapy^SM

The Condition

• Spasticity, or tight stiff muscles, is a condition that makes movement, especially of the arms or legs, difficult or uncontrollable.
• Injury or disease of the central nervous system may cause spasticity. Examples include spasticity of cerebral origin, which may be caused by cerebral palsy, stroke, or brain injury; or spasticity of spinal origin, which may be caused by multiple sclerosis or spinal cord injury.
• While the exact incidence of spasticity is unknown, about half a million people in the United States, and more than 12 million worldwide, are afflicted with spasticity.

The Consequences

• In some individuals, untreated spasticity can lead to serious orthopedic problems such as muscle contractures, a permanent shortening of muscle fibers that can make joints difficult or impossible to move.
• People with spasticity may also have spasms — sudden, involuntary muscle contractions.
• Everyday activities such as walking, eating, dressing, or bathing can become time-consuming and difficult for individuals with spasticity, as well as their caregivers.

Treatment Options

• Depending on the severity of the spasticity, individuals and their health care professionals can design treatment programs consisting of one or more of the following treatment options:
  • Physical and occupational therapy
  • Oral medications
  • Injections into the spastic muscles
  • Orthopedic surgery or neurosurgery
  • Medtronic ITB Therapy^SM

ITB Therapy^SM

• ITB Therapy^SM (Intrathecal Baclofen Therapy), approved by the U.S. Food & Drug Administration in 1992 (severe spasticity of spinal origin) and 1996 (severe spasticity of cerebral origin), uses a programmable pump that is surgically implanted and connected to a catheter to deliver a liquid form of baclofen directly into the intrathecal space where fluid flows around the spinal cord.
• Because the drug is delivered directly to where it is needed in the spinal fluid, it does not circulate throughout the body in the blood. This may help minimize potential side effects that often accompany oral baclofen.
• Since 1992, more than 50,000 Medtronic baclofen pumps have helped individuals worldwide manage severe spasticity,
• ITB Therapy has been shown in studies to significantly reduce spasticity.^2,3,4
• There have been reports that ITB Therapy helped people be more independent, allowing them to feed or dress themselves, sit more comfortably, or transfer more easily. ^5,6,7,8
• Caregivers also reported satisfaction with ITB Therapy. ^9,10

ITB Therapy Candidates

• Candidates for ITB Therapy include those with severe spasticity of spinal cord or cerebral origin.  Those with severe spasticity of spinal cord origin must have either not responded to or experienced intolerable side effects from oral baclofen. Traumatic brain injury patients must wait one year post-injury prior to receiving ITB Therapy.
• A screening test determines if ITB Therapy might work. During the test, a health care professional injects a test dose of medication into the fluid around the spinal cord. If spasticity is significantly reduced, the person may be considered a candidate for ITB Therapy.

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 multi