ITB TherapySM

Intrathecal Baclofen Therapy

Information for you and your family

For the management of severe spasticity

Committed to restoring people to full livesWith the invention of the pacemaker, Medtronic created a whole new industry based on medical technology. For more than 50 years, Medtronic has worked with physicians around the world to create products and therapies that alleviate pain, restore health, and extend life. In fact, Medtronic currently provides products and services that treat more than 5 million people each year. For more information about Medtronic, visit us online at www.medtronic.com.

Visit us online at www.spasticity.com

Table of ContentsThis guide was designed to introduce you to Medtronic ITB TherapySM* (Intrathecal Baclofen Therapy) and answer many of your questions. We hope you find it helpful. Words that appear in bold type are defined in the glossary at the back of this booklet. Your clinician can provide even more information and help you determine if ITB Therapy is right for you.

Spasticity ... you Can Do Something about It ...............................................2

about Medtronic ITB TherapySM ........................................................................3

Benefits of ITB Therapy .........................................................................................4

risks associated with ITB Therapy ...................................................................5

Determining If ITB Therapy Is right for you ..................................................5

The Day of your Screening Test ........................................................................6

everyone responds Differently ..........................................................................6

What happens after the Standard Screening Test? .................................7

If ITB Therapy Is right for you ............................................................................8

Surgery ........................................................................................................................9

post-Surgery Care ................................................................................................. 10

Therapy Maintenance ......................................................................................... 10

Device-related events .......................................................................................... 11

Living with your programmable pump ........................................................... 12

What Is your role in Making ITB Therapy Work? ....................................... 13

Creating New possibilities................................................................................... 13

Spasticity ... you Can Do Something about It ............................................. 14

embrace the possibilities .................................................................................... 14

Common Questions .............................................................................................. 15

Lioresal® Intrathecal patient Information ....................................................20

Glossary .................................................................................................................... 22

references .............................................................................................................. 24

For More Information ........................................................................Back Cover

* Please refer to the Lioresal® Intrathecal (baclofen injection) patient information on page 20 of this brochure.

This guide contains the experiences of several individuals with ITB Therapy. It is important to keep in mind that individual experiences vary. Not every individual will have the same results. Side effects can occur. For complete prescribing information please refer to page 20 of this guide.

About Medtronic ITB TherapySM

ITB Therapy is Intrathecal Baclofen Therapy, a treatment option that deliv-ers an injectable form of baclofen, Lioresal® Intrathecal (baclofen injection), directly to the fluid surrounding the spinal cord. The medication is delivered using a programmable pump that is surgically placed and connected to a catheter in the body. The medicine is delivered continuously based on the prescription programmed by your doctor. This method of drug delivery is called intrathecal infusion. The drug infusion system delivers the medication in small, precisely controlled doses throughout the day.

What makes ITB Therapy different from oral medications is the delivery of the medication to the site where it is used — the fluid-filled area surrounding the spinal cord called the intrathecal space. Intrathecal baclofen relieves severe spasticity with only small amounts of medication. Unlike oral medications, which circulate throughout the body in the blood (see systemic drug delivery), the drug is delivered where it is most effective. This may help minimize side effects, such as weakness, drowsiness, nausea, or other negative effects that often accompany oral baclofen or other medications. People who are extremely sensitive to oral baclofen are not candidates for ITB Therapy.

Because ITB Therapy delivers Lioresal Intrathecal directly to the spinal cord, it relieves spasticity with smaller amounts of medication than when taken orally. This helps minimize systemic side effects.

The information on the following pages may help you determine if this treatment option may be right for you or your loved one.

Spasticity... you Can Do Something about It

Spasticity is tight, stiff muscles that make movement, especially of the arms and legs, difficult or uncontrollable. It happens when there is injury to a part of the central nervous system (the brain or spinal cord) that controls voluntary movements. The damage causes a change in the balance of signals between the nervous system and muscles. The imbalance leads to increased activity or spasms in the muscles. Common conditions associated with spasticity include cerebral palsy, brain injury, stroke, multiple sclerosis, and spinal cord injury. Sometimes spasticity can be very difficult to control and can get in the way of activities of daily living.

Treating spasticity may:n Improve function,1 including gait, hygiene, activities of daily living,

and ease of care.n Decrease spasm frequency, pain, and fatigue.2

n Promote tone reduction, increased range of motion, and joint position.3

n Increase mobility.4, 5

n Complement other treatments, such as physical therapy, occupational therapy, and speech therapy.

The treatment of severe spasticity may require a combination of approaches, and you or your loved one may have tried one or many of the available treatment options. One of the most common methods for treating spasticity is an oral medication (pills) called baclofen, a potent muscle relaxant. Although oral baclofen works for thousands of people, some may require high doses to effectively man-age their spasticity. A high level of drug circulating throughout the body may cause intolerable side effects such as weakness, drowsiness, nausea, or other negative effects, and still may not obtain the desired results. There are other ways to control spasticity. Your clinician or physical therapist may talk to you about ITB Therapy.

“ The pump has helped Shellie enjoy life again. She is happy, comfortable, and joyful.” – alison, family caregiver/Shellie’s mom

Shellie S. | person with a brain injury receiving ITB Therapy since 1997

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Julie M. | Living with multiple sclerosis receiving ITB Therapy since 1996

“ After she got the pump, it became much easier for Ali to move around in physical therapy.” – Debby, Ali’s mother

Ali | Receiving ITB Therapy since 1993

Spinal Cord Injuryn ITB Therapy provides long-term control (>7 years), which can be achieved in

most spasticity of spinal origin.21

n ITB Therapy results in a reduction in spasticity and spasms.18

n ITB Therapy has been shown to improve bowel and bladder performance.9, 22 n Performance of activities of daily living (bathing, dressing lower body,

transfers)8, 9, 23 and quality of life24 improves with ITB Therapy, with a small number of significant complications.

Brain Injuryn ITB Therapy results in a significant reduction in spasticity and spasms,

which leads to marked reduction in spasticity-related pain.26

n With ITB Therapy, nursing and movement become much easier.26 n ITB Therapy has been shown to reduce spasticity in both the upper and

lower limbs.27

Risks Associated with ITB TherapyThe side effects of intrathecal baclofen include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. As with most medications, overdose (drug dose is too high) or underdose (drug dose is too low) can occur. Talk with your clinician about the side effects you may experience from your treatment. For more information, please refer to the information on Lioresal Intrathecal on page 20 of this brochure.

Determining If ITB Therapy Is Right for YouA standard screening test determines if ITB Therapy may work for you. Your clinician will inject a small dose of Lioresal Intrathecal into the intrathecal space (where fluid flows around your spinal cord). If your muscles become looser, ITB Therapy may work effectively for you.

Your muscles will most likely relax when you receive the test dose of medication.

In clinical studies, a positive response to the screening test was demonstrated in:

n 97% of patients with spasticity of spinal origin20—spinal cord injury, multiple sclerosis

n 86% of patients with spasticity of cerebral origin17—brain injury, cerebral palsy

Benefits of ITB TherapyIn studies, people have anecdotally reported that Medtronic ITB Therapy helped them to:

n be more independent, allowing them to feed or dress themselves6–9

n sit more comfortably or transfer more easily6–9

Additionally, caregivers have reported that care is easier with ITB Therapy.6–9

Furthermore, people receiving ITB Therapy and their caregivers have expressed high rates of satisfaction with the therapy. Consider these statistics:

n ITB Therapy demonstrated the highest patient satisfaction rating compared with all oral treatments.2

n More than 94% of caregivers are satisfied with ITB Therapy.10

n 81% of care providers “strongly agreed” that they would repeat the (pump) procedure.11

n More than 80% of caregivers would recommend ITB Therapy to others.10

ITB Therapy may be used to treat severe spasticity related to a number of conditions. Following is information on the effect of ITB Therapy on those conditions.

Stroken Studies have demonstrated that ITB Therapy has no effect on the unaffected

side of the body.12

n ITB Therapy results in improvement in walking speed, functional mobility, and spasticity.13

n ITB Therapy significantly improves stroke survivors’ muscle tone, function, and quality of life.1

Cerebral Palsyn ITB Therapy results in improved function.14

n Study results have shown that reduction in muscle tone with ITB Therapy may slow or prevent the development of hip problems, including dislocation.14

n ITB Therapy helps facilitate improvements in self-care and social function.15

n If ITB Therapy is offered at the appropriate time, orthopedic or neurologic surgery may be delayed or avoided altogether.16

n ITB Therapy provides long-term control (>11 years) in spasticity of cerebral origin with side effects usually managed by dose adjustments.17

Multiple Sclerosisn ITB Therapy results in significant decrease in spasticity.18, 19

n ITB Therapy results in improved function.19, 20

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The Day of Your Screening Testn Your clinician will review the screening test procedure with you in detail.

Be sure to discuss any questions or concerns you may have. n You will check into a medical facility for the screening test, either the night

before or the day of the test. The screening test procedure includes injection of the medication followed by monitoring for several hours (usually 8 to 12 hours), depending on the facility’s procedures.

n Before the procedure, your clinician might conduct a variety of tests to assess your spasticity and its impact on your ability to perform various tasks including activities important to your daily routine.

n Your clinician probably will numb a small area of your lower back. A small dose of the medication then will be injected into your intrathecal space, the area where fluid flows around your spinal cord. Only a small amount of medication is injected, but it is enough to have an effect in most people.

n The medication may take 30 minutes to 1 hour to begin to relax your mus-cles. You could begin to feel the medication’s greatest effect about 4 hours after the injection, and the effect usually lasts 6 to 8 hours or more.

n After the effect of the medication wears off, you will return to the same amount of spasticity that you had before the screening test.

During the screening test, your clinician will regularly monitor your vital signs (pulse, respiration, blood pressure) and the amount of spasticity in your muscles. By measuring and comparing your spasticity before and during the screening test, you and your clinician will be able to see what effect the medication is having.

Everyone Responds DifferentlyEveryone responds differently to the test dose. The medication probably will relax your muscles. Your muscles may loosen only slightly, or your muscles might feel so completely loose or weak that you can’t use them, especially your legs. Either response simply means that ITB Therapy may work for you.

If your muscles do become completely loose, it is important to realize that this is temporary and usually not cause for concern. This weakness happens when you receive the medication all in one dose rather than gradually throughout the day as a pump would deliver the dose. The effect is temporary. When the effect of the medication wears off, you will return to the same amount of spasticity you had before the screening test.

During the screening test, these temporary side effects are possible:

n Overly loose muscles n Headachen Sleepiness n Dizzinessn Nausea/vomiting

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Be sure to tell your clinician if you experience any of these possible side effects.

If you decide to go on to receive ITB Therapy, you and your clinician will work together to adjust the pump to manage your spasticity by delivering the dose of medication that’s just right for you.

What Happens After the Standard Screening Test?After your screening test is complete, you and your clinician will discuss your results and determine if you are a candidate for ITB Therapy.

Sometimes people don’t respond to the first test dose of medication. If this happens, your clinician may give you a second test dose using the same pro-cedure. The second dose may be given the next day, or the procedure may be rescheduled for another time. If this still does not loosen your muscles, your clinician may give you an even larger dose. If this dose does not loosen your muscles, you likely are not a candidate for ITB Therapy.

Please discuss any questions you may have with your clinician and be sure to discuss the long-term benefits and risks of ITB Therapy.

For more information about the screening test, ask your clinician for a copy of the ITB Therapy screening video.

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“ After she got the pump, it became much easier for Ali to move around in physical therapy.” – Debby, family caregiver/ali’s mother

Ali G. | Living with cerebral palsy receiving ITB Therapy since 1993

Ali | Receiving ITB Therapy since 1993

If ITB Therapy Is right for you SynchroMed Pump: The SynchroMed pump is an implantable, battery-powered device that stores and dispenses medicine according to instructions provided by your clinician.

Intrathecal Catheter: The intrathecal catheter is a thin, flexible tube that connects to your programmable pump and delivers medication from the pump to the area where fluid flows around the spinal cord — called the intrathecal space.

Medtronic Programmer: Your clinician will use a programmer during your refill and checkup sessions. The programmer is the external component of the SynchroMed System. The programmer allows your clinician to communicate with your SynchroMed pump and program it to deliver the right amount of medicine.

SurgeryThe SynchroMed System is placed during a surgical procedure that may require a brief hospital stay. During the surgery, the pump is placed just under the skin of your abdomen and connected to the catheter.

As with any surgical procedure, complications may occur after the pump is placed. Since the pump and catheter are placed beneath the skin, infections can develop and are generally related to the healing of the surgical incision, not to the long-term use of ITB Therapy.

In addition to surgical complications, there is potential that you may experience:

n Side effects caused by the medications used in the pumpn Symptoms of drug overdosen Symptoms of drug underdose

Talk with your clinician about the potential side effects and complications associated with your medication and surgical procedure.

If you and your clinician decide ITB Therapy is right for you, you will be scheduled to receive a Medtronic SynchroMed® Programmable Drug Infusion System.

The SynchroMed System offers a fully implantable and program-mable method of continuous drug delivery. In use clinically since 1982, and commercially since 1988, the programmability of the SynchroMed system allows:

n Dosages to be varied throughout the day and tailored to match your individual medication needs.

n The potential for doses lower than would be needed with oral medications, which may result in reduced side effects.

n Non-invasive dose changes.

The SynchroMed System consists of:

n Implantable pump

n Implantable catheter

n External programmer

“ When I got the pump, everything became easier. Getting dressed only takes about five minutes, and I do it by myself.”

– T.J. F. | Living with spinal cord injury receiving ITB Therapy since 1989

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If ITB Therapy Is right for youIf ITB Therapy Is right for you

“ After she got the pump, it became much easier for Ali to move around in physical therapy.” – Debby, Ali’s mother

Device-Related EventsThe programmable pump is designed to automatically deliver your medication at the rates and amounts you and your clinician determine best meet your needs.

Problems with the pump and catheter for ITB Therapy may result in:

n Return or increase in spasticity. n Drug withdrawal symptoms (please refer to information on Lioresal

Intrathecal on page 21).n Need for surgical removal of the pump or catheter adjustment. n Delivery of medication into the area under your skin where the

programmable pump is placed or along the catheter path.

Talk with your clinician about any additional complications associated with your treatment.

“ The pump has brought back my life to me. My husband and I can do things on the weekends that we couldn’t do before the pump. I can go to a movie and walk into the theater without a cane. I have the stamina to go out for dinner with friends.”

– Pam B. | Living with multiple sclerosis receiving ITB Therapy since 2004

Post-Surgery Care After surgery, there will be some discomfort and tenderness where your programmable pump and catheter for ITB Therapy are placed. Your clinician may prescribe medication to relieve the pain caused by surgery and antibiotics to prevent infection. If you notice any swelling, pain, or redness near your incision, notify your clinician.

Your clinician may recommend that you restrict activity for six to eight weeks after surgery. Once your incision has healed, the pump site requires no special care. However, you should talk with your clinician if you perform any excessive or repetitive activities that may damage your programmmable pump and catheter.

Therapy MaintenanceThe key to effective therapy management is active involvement and coopera-tion with your clinician. One of your most important responsibilities is to ensure the maintenance of the pump by making regular return visits to your clinic for follow-up care.

The frequency of follow-up visits varies from weeks to months, depending on the dose of your medication. These short visits are necessary to have your programmable pump refilled with medicine and the prescription adjusted. Your clinician will also check the pump to make sure it is working properly. During a typical session, the programmable pump will be emptied and refilled by a needle inserted through your skin. This is a relatively short and painless procedure.

It is important to keep and attend all of your refill appointments to maintain the level of medication you need for continuous and effective therapy and to monitor the performance and battery levels of your programmable pump. The battery lasts several years. The battery life depends on how much medicine you are programmed to receive each day. Before the battery runs out, you will need to replace your pump with a new one through a surgical procedure. The catheter usually can stay in place and be reconnected to the new programmable pump. Furthermore, it is very important that you know and understand the signs of baclofen withdrawal (see page 21). Be sure to tell your clinician right away if you experience any unusual symptoms, side effects, or changes in your condition.

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“ ITB Therapy isn’t saving my life, but it helps me live my life without worrying about my disability. In a sense, that is saving my life.”

– Jason F. | Living with spinal cord injury receiving ITB Therapy since 1991

What Is Your Role in Making ITB Therapy Work?When receiving ITB Therapy, it is very important for you to follow your clinician’s instructions. You should also:

n Carry your patient ID card and emergency cards with you at all times.n Always keep your follow-up and refill appointments.n Tell your clinician if you don’t feel well or if you are having problems with

the programmable pump.n Immediately notify your clinician if you hear a pump alarm.n Learn the programmable pump name (SynchroMed) and model number and

the name of the medication used in the pump — Lioresal Intrathecal. n Tell your other clinicians and your dentist about ITB Therapy.n Make sure your family and friends know about the programmable pump, so

they can help in an emergency.n If you plan to travel, tell your clinician so she or he can make sure enough

medicine is in your programmable pump.

Creating New PossibilitiesBy reducing your severe spasticity, ITB Therapy may create some new possibilities for you. For example, you may be able to participate more fully in rehabilitation therapies, such as physical and occupational therapy. Combining these therapies with ITB Therapy may allow you to achieve new and different goals that were unattainable due to severe spasticity.

Intensive physical therapy (3–5 times per week) may begin 6–8 weeks after you start receiving ITB Therapy. Regardless of whether you have undergone therapy before your surgery, you may be able to make significant advances that were not previously possible.

As you begin receiving ITB Therapy, you will be able to resume your daily activities. Your awareness of the programmable pump will lessen. Since there are no external parts, you may forget it’s there.

You may find that wearing loose clothing is most comfortable. Depending on your size and body type and where the program-mable pump is placed, it may not show at all under regular clothes.

Your clinician will prescribe and adjust the amount of medication to best meet your needs. As you become more active, discuss your level and type of activity with your clinician. Follow your clinician’s suggestions about work, sexual activity, travel, recreation, hobbies, and exercise.

Your clinician will let you know how often you need to get the programmable pump refilled. It has an alarm that will beep softly when it should be checked. If you hear the alarm, call your clinician to determine the cause and to make the necessary adjustments.

Living with your programmable pump

“ ITB Therapy has given me independence to continue doing the things I’ve always enjoyed.”

– Mary C. | Stroke survivor receiving ITB Therapy since 2003

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“ I know the difference [the pump] has made in my child’s life. He’s doing so many things that he may not have been able to do had he not had this opportunity.” – eve, family caregiver/Nick’s mom

Nick C. | Living with cerebral palsy receiving ITB Therapy since 1999

For additional information about ITB Therapy, visit www.spasticity.com.

What is spasticity?Spasticity is tight, stiff muscles that make movement — especially of the arms and legs — difficult or uncontrollable. Sometimes spasticity is so severe that it gets in the way of daily activities, sleep patterns, and caregiving, and can even threaten people’s safety.

What is ITB Therapy?ITB Therapy is Intrathecal Baclofen Therapy, a unique treatment that delivers a liquid form of baclofen, called Lioresal Intrathecal, directly to the fluid surrounding the spinal cord. The medication is delivered in small, precisely controlled doses using a programmable pump and catheter that are surgically placed.

Can you tell me more about the pump?The programmable pump is surgically placed, usually just under the skin of the abdomen. The device is round and metal and 74 mm in diameter. Most people report that the programmable pump is not uncomfortable or restric-tive and does not interfere with their movement. Depending on your size and shape, it may not show at all under regular clothes.

Does the pump run out of medication?Your programmable pump needs to be refilled with medication periodically, using an external procedure performed in your clinician’s office.

Refill dates are scheduled based on:

n The amount of medication your programmable pump holds. n The concentration of the medication you are receiving. n The rate at which the pump delivers medication. n The frequency of dosing changes required by your particular treatment plan.

Common QuestionsSpasticity ... You Can Do Something About ItWith ITB Therapy, you may be able to improve functional abilities and your quality of life.1, 7–9 Discuss any questions you have with your health care team. Talk to your clinician about the potential long-term benefits and possible risks associated with ITB Therapy.

ITB Therapy is available by prescription only. Please refer to the information on Lioresal Intrathecal on page 20, or visit www.spasticity.com for complete prescribing information.

“ At first I thought the pump was going to do something for me. Then I realized the pump allowed me to do things for myself.”

– Ricky M. | Stroke survivor receiving ITB Therapy since 2001

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Jennifer W. | Living with cerebral palsy receiving ITB Therapy since 2000

Embrace the PossibilitiesIf you have questions, or would like additional information, you may wish to take advantage of some of our resources:

n For more information on ITB Therapy, visit: www.spasticity.com or call 1-800-856-3823.

n Talk with your clinician about ITB Therapy. n Visit www.exploringspasticity.com for resources

and information on spasticity.

What if I need some spasticity for transfers, walking, or standing? Will ITB Therapy take this away?Your clinician can program the SynchroMed pump to deliver the precise amount of medication that you need. It can even be set to deliver different amounts at different times of the day, if needed. For example, the pump can be set to deliver less medication in the daytime when you may rely on your stiffness to walk, transfer, or put on clothes, then automatically deliver more medication at night to reduce spasticity to help you sleep.

Will ITB Therapy improve my comfort or physical ability?It is important to note that this therapy cannot give you any abilities that you do not already have. It may, however, relieve the spasticity that often prevents individuals from using these abilities or realizing their full potential. Appropriate goal-setting with your clinician is a key to satisfaction with your treatment regimen.

In studies, people have anecdotally reported that Medtronic ITB Therapy helped them be more independent, allowing them to feed or dress themselves, sit more comfortably, or transfer more easily.6–9

Additionally, caregivers have anecdotally reported that care is easier with ITB Therapy6–9 and they have “reported a reduction in use of oral medication for spasticity, and improvements in comfort, function, and ease of care.”10

Can I stop taking other medications once I have a pump?Your clinician will determine if you still need to take other medications.

How will alcohol or other medications affect me?The drowsy effect of Lioresal Intrathecal may add to the effect of alcohol or other depressants. Drowsiness has been reported in patients receiving Lioresal Intrathecal. You should be careful driving, operating dangerous machinery, or taking part in activities that may be dangerous if you are not alert.

Does the SynchroMed pump or Lioresal Intrathecal affect sexual function?There have been reports of patients who have been affected. This usually is not permanent and may be helped by changing the dose of Lioresal Intrathecal.

What happens if the programmable pump runs out of medication?Abruptly stopping Lioresal Intrathecal can result in serious medical problems and in rare cases has been fatal. For more information, please refer to the information on Lioresal Intrathecal on page 21 of this brochure.

How long does a refill procedure take?The average time varies from clinic to clinic, depending on their procedures. However, on average, a refill appointment lasts about 30–45 minutes. During the refill procedure, your clinician will place a plastic template on your skin, over the area where your pump is implanted. This template will help him or her locate the refill port on your pump. Your clinician will refill your pump by inserting a needle through your skin into your pump.

How do I know if ITB Therapy will work for me?To determine whether you are a candidate for ITB Therapy, your clinician will give you a screening test. A small dose of Lioresal Intrathecal is injected into the intrathecal space (where fluid flows around the spinal cord). Then your clinician will see how much your muscles relax over the next 6 to 8 hours.

Will ITB Therapy cure my spasticity?No, ITB Therapy is used to manage severe spasticity but cannot take away its cause. ITB Therapy is not a cure for spasticity or the conditions that are associated with it.

If oral baclofen didn’t work for me, why would ITB Therapy work?ITB Therapy delivers a liquid form of baclofen, Lioresal Intrathecal, directly into the intrathecal space, where fluid flows around the spinal cord. ITB Therapy relieves severe spasticity with small amounts of Lioresal Intrathecal delivered via a programmable pump that is surgically placed and connected to a catheter in the body. What makes ITB Therapy different from oral medications is the delivery of the medication to the fluid-filled area surround-ing the spinal cord. Because the drug is delivered directly to where it is needed in the spinal fluid, only minimal amounts circulate throughout the body in the blood. This helps minimize the possible side effects that often accompany oral medications.

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methods for the drug should be used during the time required for the MRI and if medical supervision should be provided while the MRI is conducted. Your clinician should check your programmable pump after an MRI to confirm it is still working properly.

During an MRI, you may notice a warming sensation around the programma-ble pump or feel a tingling sensation. If the warming or tingling sensation is uncomfortable to you, the MRI should be stopped and the settings adjusted to reduce or eliminate the sensation. During an MRI, you may also notice a slight tugging sensation at the pump. An elastic garment or wrap will reduce the tugging sensation. Additionally, the metal in the programmable pump may cause the MRI image to be distorted in the area around the pump. The MRI should be adjusted to minimize the image distortion.

Can I have a diagnostic ultrasound?Electromagnetic interference (EMI) from diagnostic ultrasound (e.g. carotid scan, doppler studies) is unlikely to affect your SynchroMed pump.

Note: to minimize potential image distortion, the transducer must be kept 15 cm (6 in) away from the infusion system.

Will the use of a cellular phone affect my pump?Your programmable pump is protected from low-powered stray electromag-netic interference (EMI) that is present in a typical cellular phone. However, if your phone is near your programmable pump (1 meter), be sure to turn your phone OFF prior to any telemetry on your pump to help prevent EMI. Some cellular phones (not all kinds) contain a tiny magnet.

Will a microwave oven affect my pump?The programmable pump has built-in features to protect it from interference produced by electrical devices found in the household. Under normal condi-tions, the household appliances you use in your daily activities will not affect the programmable pump.

Be sure to keep all household appliances in good working condition. If you suspect interference with your programmable pump, move away from or turn off the electrical device. The programmable pump will not be permanently affected.

On average, how long does the surgery take? Times vary depending on individual surgical techniques. On average, the procedure takes one to two hours from start to finish. Talk with your clinician about specifics and duration of your procedure.

Is ITB Therapy covered by insurance?ITB Therapy is an FDA-approved, commercially available treatment and is cov-ered by most health insurance companies, Medicare, and most state Medicaid programs for the approved indications. Talk to your clinician, insurance agent, or benefits manager if you have questions.

What are the most common side effects of Lioresal Intrathecal?The side effects of Lioresal Intrathecal include loose muscles, sleepiness, upset stomach and vomiting, headaches, and dizziness. Talk with your clinician about the possible side effects you may experience from your treatment. For more information about Lioresal Intrathecal, please refer to page 20 of this brochure, or visit www.spasticity.com.

For stroke survivors, will ITB Therapy affect the “good” side?In a clinical study, no objective or subjective motor weakness was noted on the unaffected (or “good”) side.1, 12

Can I undergo MRI testing?Contact your clinician before having Magnetic Resonance Imaging (MRI) performed. Your clinician will recommend whether or not an MRI is appropriate for you.

Programmable pump performance has not been established for Magnetic Resonance Imaging (MRI) scanners at fields greater than 1.5 T (Tesla) scan-ners. Patients with ITB Therapy should not have an MRI using these scanners.

The MRI will cause your programmable pump to temporarily stop and sus-pend drug delivery during the MRI. The MRI may also cause your program-mable pump to temporarily sound an alarm. This is normal with an MRI. The pump should resume normal operation after the MRI is complete. The effects of temporary suspension of medication will depend on the medication used in your programmable pump. Your clinician will determine if alternative delivery

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Q: What are the signs of rapid or abrupt withdrawal from intrathecal baclofen? A: Increase or return in spasticity, itching, low blood pressure, lightheaded-ness, and tingling sensation are often early indications of baclofen withdrawal. It is very important that your doctor be called right away if you experience any of the above symptoms.

In rare cases, severe symptoms may occur. These symptoms include high fever, altered mental status, spasticity worse than before you started ITB Therapy, and muscle rigidity. It is very important that your doctor be called right away if you experience any of the above symptoms.

Q: What can I do to prevent baclofen underdose or abrupt discontinuation of intrathecal baclofen? A: It is very important that you keep all of your refill appointments. This may require some planning prior to traveling. Maintaining a regular refill schedule will ensure the pump does not run out of medication and that any potential problems with the infusion system are diagnosed and corrected. Additionally, you should be aware of what your pump alarms sound like. If you hear an alarm, contact your doctor immediately.

Furthermore, it is very important that you know and understand the signs of baclofen underdose. Also be sure to tell your doctor right away if you experi-ence any unusual symptoms, side effects, or changes in your condition.

Q: What are the symptoms of baclofen overdose? A: Although rare, it is possible for you to receive too much medication (over-dose). A baclofen overdose may cause drowsiness, lightheadedness, respiratory depression (difficulty breathing), seizures, loss of consciousness, and coma. If you experience any of the above symptoms, it is very important that you or your caregiver contact your doctor right away.

Rx only.

Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation

This provides a summary of the most important information about Lioresal Intrathecal. If you would like more information, talk with your doctor. You can ask for information about Lioresal Intrathecal that is written for healthcare professionals. You also can get more information by visiting www.spasticity.com.

LIORESAL® INTRATHECAL (baclofen injection 40 mg/20 mL, 10 mg/5 mL, 10 mg/20 mL,

0.05 mg/1 mL)

Completely read this information before you start using Medtronic ITBTM Therapy (Intrathecal Baclofen Therapy). This information does not take the place of thorough discussions with your doctor. You and your doctor should discuss ITB Therapy before you begin receiving the therapy and at regular refill appointments.

Q: What is Lioresal® Intrathecal (baclofen injection)? A: Lioresal Intrathecal is a liquid form of baclofen, and is commonly used to treat severe spasticity. Liquid baclofen is used for injections and infusion into the intrathecal space (the fluid-filled area surrounding the spinal cord), using an implantable drug delivery system.

Q: What is severe spasticity? A: Severe spasticity is tight, stiff muscles that make movements — especially of the arms and legs — difficult or uncontrollable. Severe spasticity can interfere with an individual’s function and/or comfort.

Q: Who is a candidate for Lioresal Intrathecal? A: People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, traumatic brain injury, or spinal cord injury, and who suffer intolerable side effects from oral baclofen (pills), may be a candi-date for Lioresal Intrathecal. A screening test will help determine if you will respond to the intrathecal medication. Talk with your doctor about whether Lioresal Intrathecal may be an option for you.

Q: Who is not a candidate for Lioresal Intrathecal? A: People who are hypersensitive (extremely sensitive) to oral baclofen should not take Lioresal Intrathecal.

Q: What are the most common side effects of Lioresal Intrathecal? A: The side effects of intrathecal baclofen include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. As with most medications, overdose (drug dose is too high) or underdose (drug dose is too low) can occur. Talk with your doctor about the side effects you may experience from your treatment.

Q: What do I need to know if I am using Lioresal Intrathecal? A: Abruptly stopping intrathecal baclofen can result in serious medical problems and in rare cases has been fatal. It is important to keep your pump filled with medication by attending regularly scheduled refill appointments.

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(2003)

programmable pump: round, metal disk that stores and releases liquid medicine at a rate that is programmed by a doctor.

programmer: the handheld computer used by doctors to adjust the amount of medication delivered by the SynchroMed programmable pump. The pro-grammer uses radio frequency waves to communicate with implanted pumps.

refill: to take out old drug and fill the pump with new drug.

reservoir: area inside the pump that holds the medicine.

screening test: the clinician gives the patient a small dose of Lioresal Intrathecal to see how well it works prior to pump placement.

side effect: a result of drug or other therapy in addition to or in extension of the desired therapeutic effect; usually, but not necessarily, connoting an undesired effect.

spasticity: tight, stiff muscles.

spinal cord: column of nerve tissue in the spine that carries messages between the brain and the body.

spinal cord injury: an injury to the spinal cord that disrupts communication between the brain and other parts of the body, preventing messages from flowing past the damaged area.

stroke: a stroke, or brain attack, occurs when a blood clot blocks a blood vessel or artery, or when a blood vessel breaks, interrupting blood flow to an area of the brain. When a brain attack occurs, it kills brain cells in the immediate area.

SynchroMed Programmable Drug Infusion System: a programmable pump is placed just under the skin of the abdomen and is connected to a small, flexible catheter to deliver Lioresal Intrathecal directly into the area where fluid flows around the spinal cord. The system includes a fully implantable pump, a catheter, and a programmer that is used by clinicians.

systemic drug delivery/systemic therapies: treatments that carry medication throughout the entire body, rather than to a specific location. Some examples of systemic treatments include oral medications, IV treat-ments, and patches. By contrast, site-specific drug delivery delivers the medication only to the site where it is needed most.

test dose: single dose of Lioresal Intrathecal given during the screening test.

baclofen injection: generic name for Lioresal Intrathecal, which is the drug used in the SynchroMed pump to manage spasticity.

brain injury: damage to the brain, such as that due to a severe hit in the head.

catheter: a flexible, silicone tube that connects to the pump. The pump delivers medication through the catheter to a specific area in the body.

cerebral: of the brain.

cerebral palsy (CP): a movement and posture disorder due to an injury or defect to the developing brain (brain damage).

drug infusion system: a system consisting of a pump and catheter, both of which are fully implanted and used to deliver medication. Programmable systems also feature an external programmer that is used to adjust the amount of medication the pump delivers.

intrathecal infusion/intrathecal drug delivery: the delivery of medication directly to the intrathecal space. This type of therapy can be administered with a fully implantable drug infusion system and is used to treat chronic pain or manage severe spasticity.

intrathecal space: area surrounding the spinal cord filled with cerebrospinal fluid.

ITB Therapy: treatment for spasticity using the SynchroMed Drug Infusion System (drug pump) that delivers Lioresal Intrathecal to the spinal cord.

Lioresal Intrathecal: the brand name for liquid baclofen.

multiple sclerosis: multiple sclerosis (MS) is a chronic, often disabling, disease of the central nervous system.

occupational therapy: involves adapting your physical environment to meet your needs (e.g., modifications for dressing, feeding, and grooming; creating an accessible home or workplace; or advising on the use of adaptive devices such as wheelchairs and bath equipment).

physical therapy: exercises that help stretch muscles, maintain mobility, and reduce the potential for injury. These exercises are designed to reduce muscle tone, maintain or improve range of motion and mobility, increase strength and coordination, and improve comfort.

Glossary

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Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

References 1. Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen

management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil 2006;87(11):1509–1515.

2. Rizzo M, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Multiple Sclerosis 2004;10:589-595.

3. www.MDVU.org, web site accessed 6/13/05 (http://www.mdvu.org/library/disease/spasticity and http://www.mdvu.org/library/disease/spasticity/spa_mtp.html and http://www.mdvu.org/library/disease/spasticity/spa_mbtdm.html).

4. Francisco G, Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil 2003;84:1193-1199.

5. Meythaler J, Guin-Refroe S, Brunner R, Hadley M. Intrathecal baclofen for spastic hypertonia from stroke. J Stroke 2001;32:2099-2109.

6. Albright AL, et al. Continuous intrathecal baclofen infusion for spasticity of cerebral origin. JAMA 1993;270(20):2475-2477.

7. Rawlins P. Intrathecal baclofen for spasticity of cerebral palsy: project coordination and nursing care. AJNN 1995;27(3):157-163.

8. Loubser PG, et al. Continuous infusion of intrathecal baclofen: long-term effects on spasticity in spinal cord injury. Paraplegia 1991:29:48-64.

9. Parke B, et al. Functional outcome following delivery of intrathecal baclofen. Arch Phys Med Rehabil 1989;70:30-32.

10. Campbell WM, et al. Long-term safety and efficacy of continuous intrathecal baclofen. Dev Med Child Neurol 2002;44:660-665.

11. Gooch JL, et al. Care provider assessment of intrathecal baclofen in children. Dev Med Child Neurol 2004;46:548-552.

12. Meythaler JM, et al. Intrathecal baclofen for spastic hypertonia from stroke. Stroke 2001;32:2099-2109.

13. Francisco GE, Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil 2003;84(8):1194-9.

14. Krach LE, et al. GMFM 1 year after continuous intrathecal baclofen infusion. Ped Rehab 2005;8(3):207-213.

15. Awaad Y, et al. Functional assessment following intrathecal baclofen therapy in children with spastic cerebral palsy. J Child Neurol 2003;18:26-34.

16. Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequent orthopedic surgery in patients with spastic cerebral palsy. J Neurosurg 1998;88:1009-1013.

17. Gilmartin R, Bruce D, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol 2000;71-77.

18. Coffey RJ, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg 1993;78:226-232.

19. Ordia JI, et al. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromod 2002;5(1):16-24.

20. Dario A, et al. Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion. Funct Neurol 2001;16:311-315.

21. Penn R. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Child Neurol 1992; 77:236-240.

22. Nanninga JB, Frost F, Penn R. Effect of intrathecal baclofen on bladder and sphincter function. J Urol 1989;142:101-105.

23. Azouvi P, Mane M, Thiebaut JB, Denys P, Remy-Neris O, Bussel B. Intrathecal baclofen administration for control of severe spinal spasticity: functional improvement and long-term follow-up. Arch Phys Med Rehabil 1996;77:35-39.

24. Stempien L, Tsai T. Intrathecal baclofen pump use for spasticity: a clinical survey. Am J Phys Med Rehabl 2000;79(6):536-541.

25. Albright LA, Gilmartin R, Swift D, et al. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg 2003; 98291-295.

26. Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol 1997;244:160-166.

27. Meythaler J, Guin-Renfroe S, Grabb P, Hadley MN. Long-term continuously infused intrathecal baclofen for spastic-dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil 1999;80:13-19.

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“ Because the spasticity has been reduced with ITB Therapy, I stretch better and am developing more range of motion. I look forward to getting more functional as time goes by.”

– Ed R. | Stroke survivor receiving ITB Therapy since 2004

Ali | Receiving ITB Therapy since 1993

SynchroMed® II Drug Infusion System Brief Summary / product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.

Indications / US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.

Contraindications / When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when body size is not sufficient to accept pump bulk and weight; when contraindications exist relating to the drug. Do not use the Personal Therapy Manager accessory to administer opioid to opioid-naïve patients or to administer ziconotide.

Warnings / Comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and injecting into the catheter access port (CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over infuse the drug, potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal opioid therapy carefully for any new neurological signs or symptoms. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been aspirated.

Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. Physicians must be familiar with the drug stability information in the technical manual and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system.

Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities such as strenuous exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid manipulating the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients must consult their physician before engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs, hyperbaric chambers, flights, skydiving, etc.) Inform patients that pump has an Elective Replacement Indicator (ERI) that sounds when the pump is nearing its end of service. When the alarm sounds, patients must contact their doctor to schedule pump replacement.

precautions / The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date has expired. Do not reuse or resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or below 5°C. Consider use of peri- and post-operative antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is present. For patients prone to CSF leaks, clinicians should consider special procedures, such as a blood patch. Follow instructions for emptying and filling the pump during a replacement or revisions that require removal of the pump from the pocket. Explant the pump postmortem if incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices to Medtronic for analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5 cm from the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away from pump ports before suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an extended period of time, fill the reservoir with preservative-free saline in intraspinal applications or appropriate heparinized solution (if not contraindicated) in vascular applications.

The magnetic field or telemetry signals produced by the programmer may cause sensing problems and inappropriate device responses with an implantable pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field generated by equipment found in the home, work, medical, or public environments. Most EMI normally encountered will not affect the operation of the pump. Exceptions include: injury resulting from heating of the pump which can damage surrounding tissue (diathermy, MRI), system damage which can require surgical replacement or result in loss/change in symptom control (defibrillation, electrocautery, high-output ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying symptoms, and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance imaging (MRI)). MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during MRI exposure which will cause the pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior to MRI, the physician should determine if the patient can safely be deprived of drug delivery. If not, alternative delivery methods for the drug can be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed.

adverse events / Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure, inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter in patients receiving intraspinal morphine or other opioid drugs.

USA Rx Only

October 2005

UC200605601a eN Np7358a© Medtronic, Inc. 2007all rights reservedprinted in USa

Medtronic Neurological 710 Medtronic parkway NeMinneapolis, MN 55432-5604USaInternet: www.spasticity.comTelephone: (763) 505-5000FaX: (763) 505-1000Toll-free: 1-800-328-0810

For additional information about ITB Therapy, visit www.spasticity.com.