REDUCE SPASTICITY IMPROVE YOUR LIFEITB TherapySM* is a proven treatment for reduction in post-stroke spasticity3,14,16

*ITB TherapySM = Intrathecal Baclofen Therapy

SynchroMed™ II Drug Infusion Pump

UC201811375 EE © 2018 Medtronic. All rights reserved.

CONTENTS04 What is disabling spasticity?

05 Spasticity is a burden on patients and caregivers

06 Timeline of stroke treatment

07 Treatment options

08 What is Intrathecal Baclofen Therapy?

09 How does Intrathecal Baclofen Therapy work?

10 What are the benefits of Intrathecal Baclofen Therapy?

11 Patsy’s story

12 See the signs. Talk to your doctor

13 Living with Intrathecal Baclofen Therapy

14 Possible side effects of Intrathecal Baclofen Therapy

15 References

EVERY YEAR, 15 MILLION PEOPLE AROUND THE WORLD EXPERIENCE A STROKE

After maintaining the vital functions, most patients undergo extensive neurological and neuropsychological rehabilitation after a stroke, which includes:n Treatment of impaired motor skills and balancen Treatment of swallowing and breathing impairmentsn Training of activities of daily livingn Special concepts for the treatment of cognitive deficits and

impaired behaviour

It is important to have an individual treatment programme that prepares you for independent or care-managed life after inpatient rehabilitation. This means organisation of continuing outpatient treatment and care management, as well as measurement and documentation of rehabilitation success.

Of these, 5 million will be permanently disabled,1 changing their lives forever.

UP TO 13% OF STROKE PATIENTS develop disabling spasticity2

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Spasticity is caused by an imbalance of signals from the central nervous system (brain and spinal cord) to the muscles. Your muscles are tight and stiff, making movement difficult or uncontrollable. You also have painful muscle spasms that interfere with activities of daily living.

WHAT IS DISABLING SPASTICITY?

Generally, the arms and legs are affected and mainly on one side of the body. Commonly, the elbow is bent and the arm is pressed to the chest with a bent hand. The leg is stiff and the foot is turned inwards (talipes equinus), which makes walking difficult.

LEGS

WRISTS

FEET

ARMS

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STROKE SURVIVOR PATIENT WITH SPASTICITY VS. WITHOUT

You don´t have to live with spasticity. It is a symptom that can be managed. Post-stroke spasticity needs specialised treatment, and early treatment may reduce worsening or the severity of spasticity. If you wait too long, severe spasticity can lead to contractures that needs to be treated with a surgery.

SPASTICITY IS A BURDEN ON PATIENTS AND CAREGIVERS

* Reported in patient questionnaires** Evaluated with functional test (e. g. dressing, transfer bed, wheelchair or walking)

44%OF CAREGIVERS DIAGNOSED WITH DEPRESSION OR ANXIETY7

UP TO

18%REDUCTIONIN PATIENT QUALITY OF LIFE5*

35%REDUCTIONIN PATIENT FUNCTION6**

5   5

DAY 1

StrokeIntrathecal

Baclofen Therapy

Intensive care

Rehabilitation phase adjusted on patient needs

FIRST DAYS 3 MONTHS 6 MONTHS 5 YEARS1.5 YEARS

17 – 43% of patients develop spasticity4

TIMELINE OF STROKE TREATMENT

It can take several days to 1.5 years post-stroke until development of spasticity.4 Most stroke patients recognise the first symptoms in one hand and they often spread over the affected half side of the body. Unfortunately, ITB treatment for severe spasticity is currently proposed late, approximately 5 years after stroke.3

Physical TherapyWith physiotherapy, ergotherapy and logopaedics, you can train your brain to relearn some abilities. Used alone or alongside conventional and advanced treatments.

TREATMENT OPTIONS

TREATMENT OPTIONS CAN BE COMBINED TO REACH THE BEST POSSIBLE OUTCOME

Oral MedicationOral medication can lower the burden caused by spasticity. For severe disabling spasticity, oral medication should be used at high dosage, which can cause intolerable side effects. Used until not effective any more or creates intolerable side effects.8

CONVENTIONAL TREATMENTS

SurgerySurgical interventions (e.g. tendon lengthening or transfer) can be applied to affected muscles or if contractions occur. Irreversible procedures to treat spasticity include neuroctomy, myeloctomy and rhizotomy.

Intrathecal Baclofen TherapyIf the spasticity affects more than one extremity and you have already tried other treatment options without a satisfying effect or with too many side effects, then intrathecal Baclofen Therapy can help you to lower the burden caused by spasticity and increase your function and quality of life.14,16

Injections Injection of neurolytic agents (phenol and alcohol). Spasticity can also be treated with botulinum toxin injections. This is a neurotoxin that interferes with muscle contraction process and can reduce muscle tone for about 3 months.9 Generally used for focal spasticity, i.e. in one limb only.

ADVANCED TREATMENTS

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WHAT IS INTRATHECAL BACLOFEN THERAPY?

ORAL: Systemic delivery through the circulatory system

INTRATHECAL: Targeted delivery of the drug directly to the cerebral spinal fluid

Delivers a liquid form of medicine directly to fluid around spinal cord

Requires 100 to 1000x smaller doses less medication than oral baclofen10(since it does not circulate throughout body)

Expected to produce fewer or more tolerable side effects as compared to oral baclofen11-12

FROM THEORY TO PRACTICE

8

HOW DOESINTRATHECAL BACLOFEN THERAPY WORK?

One important advantage of ITB TherapySM is that you can try if it works for you before the pump is implanted.

A standard test dose (screening test) determines if ITB TherapySM could work for you. A small quantity of liquid medication is injected directly to the fluid around the spinal cord using a syringe.

More than 9 out of 10 patients respond positively to the test dose.11-15

Intrathecal Baclofen Therapy

Maximume�ect is seen

FOLLOWINGDAYS

Test dose

Medication will gradually disappear.

You return to the same level of

spasticity you had before the test

Test can be repeated with di�erent dose

Pump implant for long-term management of spasticity

NEXT DAYEND OF DAY 14 – 8 HOURS4 HOURS30 MINS –1 HOURDAY 1

Your muscles

may begin to relax

Your medical team will carefully monitor and assess what effect the medication is having on you. If you and your medical team decide ITB TherapySM is right for you, a programmable drug infusion system will be implanted under your skin for long-term management of your spasticity symptoms.

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WHAT ARE THE BENEFITS OFINTRATHECAL BACLOFEN THERAPY?

ITB TherapySM is proven to significantly improve function and quality of life in post-stroke patients.14,16

It is very important that you discuss your individual therapy goal with your physician. There is no cure for severe spasticity, but the ITB TherapySM can help you to:17

n Be more independent n Improve walking without aidsn Walk with less restn Transfer between bed and wheelchairn Improve hand movements

(e.g, holding a glass safely)n Increase autonomy n Increase ability to dressn Decrease pain due to spasticityn Decrease number of painful spasms

IMPROVED SIGNIFICANTLY

PATIENT FUNCTION

IMPROVED SIGNIFICANTLY

PATIENT QUALITY OF LIFE

ITB TherapySM improves muscle strength in the spasticity affected limbs and does not alter the strength in the unaffected limbs.14,16

NO NEGATIVE IMPACT TO UNAFFECTED LIMBS

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This patient testimonial relates an account of an individual’s response to the treatment. The account is genuine, typical and documented. However, the individual’s response does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. The response other persons have to the treatment could be different. Responses to the treatment discussed can and do vary and are specific to the individual patient. Please consult your healthcare professional for a full list of benefits, indications, precautions, clinical results, and other important medical information that pertains to the therapy or products discussed.

PATSY’S STORY One morning in 2004, Patsy woke up to a terrible headache. A professional in the public relations field, she was on vacation that day. Later in the afternoon, she got up from the couch and collapsed on the floor. When she realized she couldn’t control her left arm or leg, a friend called 911.Patsy ended up at a stroke center where it was determined that she had a massive stroke due to a blood clot. Surgery to remove the clot resulted in the removal of one-third of the right frontal lobe of her brain. Blood tests revealed a blood clotting disorder.

SEVERE SIDE EFFECTS SET IN After her stroke, Patsy, had nine weeks of inpatient rehabilitation therapy, including physical therapy, occupational therapy and speech therapy. “The therapy was good in a practical way, but I was stuck in the hospital and I went into a depression,” Patsy recalls. “I couldn’t understand how this was God’s will for me.”Six months of outpatient physical therapy followed. Patsy’s brother moved in with her so she could stay in her home. “I had horrible clonus – shaking and tremors – in my left foot, and my left arm curled up across my chest,” Patsy recalls. Botox injections provided only temporary relief, and oral baclofen left her feeling extremely fatigued. “I didn’t want to get out of the chair or do anything,” she says. “It was so painful that I could hardly walk.”As Patsy’s ability to walk deteriorated, it threatened her ability to return to living alone. After a particularly bad fall, her physical therapist recommended ITB TherapySM to Patsy and her physical medicine and rehabilitation doctor. Patsy shared the information with her nine siblings – her support network – who she refers to as “the committee.” Everyone agreed that she should try it.

GETTING THE PUMP Patsy had a one-day screening test to see if long-term therapy with ITB TherapySM would be effective. “It was immediate,” she says. “My left arm dropped down to my waist, and when I walked, I took a normal heel-to-toe stride. That gave me so much hope!”Six weeks later, Patsy had the pump placed. “Afterward, I could walk and it didn’t hurt, and I didn’t have any clonus. It was like something out of dream.”A few months later, Patsy noticed clonus returning. “I couldn’t move my leg – it was like lead – and my arm was curling again. I felt horrible itching.” At the hospital, her doctor discovered that the catheter had malfunctioned, sending Patsy into baclofen withdrawal. The catheter was replaced and Patsy’s symptoms went away.While this was Patsy’s only complication, some people do experience surgical complications, side effects of the drug, or both. There are risks associated with treatment with a baclofen pump. To learn more about side effects, please see page 14. Six years later, Patsy had her pump replaced (the average life of a pump is seven years). Every three months, she goes to the doctor to have the pump refilled with baclofen.

PATSY’S STORY

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SEE THE SIGNSTALK TO YOUR DOCTOR

IF YOU EXPERIENCE SIGNS OF SPASTICITY TALK TO YOUR DOCTOR ABOUT FURTHER TREATMENT

For more information about the treatment of post-stroke spasticity, visit medtronic.eu/spasticity-expert-finder

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LIVING WITH INTRATHECAL BACLOFEN THERAPY

* Medtronic data on file ** Medtronic, SYNCHROMED™ II 8637 infusion system, patient manual

SINCE 1992, MORE THAN 300,000 PATIENTS ACROSS THE WORLD CARRY A PROGRAMMABLE DRUG INFUSION SYSTEM*

To benefit fully from ITB TherapySM, it is important that you take the following precautions:

Attend scheduled visits for refills and prescription adjustments.

Have your pump replaced at least after 7 years.18 An alarm is activated 90 days before battery life ends, giving you enough time to schedule a medical appointment.

It is safe to undergo medical exams, including MRI with the pump as long as you inform your medical team**.

Alert your medical team if sudden changes occur in your spasticity that could be the result of under or over-infusion.

The pump is designed to allow the safe use of most common household appliances such as microwave ovens, TV, radios, mobile phones, etc.

There are no specific travel restrictions. Flying will not affect the pump or the delivery of ITB TherapySM.

SynchroMed™ II Infusion System

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The most common side effects of ITB TherapySM are related to the drug itself.

Drug delivery parameters can be adjusted to minimise side effects.

The pump can also be removed to return to your initial level of spasticity.

Muscular weakness, hypotonia, urinary retention, fall, somnolence and dizziness.

DRUG

Surgical complications are possible and include headache, intracranial hypotension, spinal fluid leak, implant site infection.3,14 Once the pump and the catheter are implanted, device complications (e.g. device dislocation, cathether occlusion) may occur that require surgery to resolve.*

PROCEDURE AND SYSTEM

* Please refer to the medicinal product’s patient information leaflet for a complete list of adverse events. If you recieve any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system.

POSSIBLE SIDE EFFECTSOF INTRATHECAL BACLOFEN THERAPY

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REFERENCES

1. World Health Organization. Global burden of stroke. http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.pdf?ua=1

2. Dvorak EM, Ketchum NC, McGuire JR. The underutilization of intrathecal baclofen in poststrokespasticity. Top Stroke Rehabil. 2011;18(3):195–202.

3. Creamer M, Cloud G, Kossmehl P, et al. Intrathecal baclofen therapy versus conventional medical management for severe post-stroke spasticity: Results from a multicentre, randomised, controlled, open-label trial (SISTERS). J Neurol Neurosurg Psychiatry. 2018 Jan 11. pii: jnnp-2017-317021. doi: 10.1136/jnnp-2017-317021. [Epub ahead of print]

4. Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013;80(Suppl 2):S13–S19.

5. Gillard PJ, Sucharew H, Kleindorfer D, et al. The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study. Health Qual Life Outcomes. 2015;13:159. doi:10.1186/s12955-015-0340-3.D

6. Welmer et al. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21:247–53.

7. Denno MS, Gillard PJ, Graham GD, et al. Anxiety and depression associated with caregiver burden in caregivers of stroke survivors with spasticity. Arch Phys Med Rehabil. 2013;94(9):1731–6. doi:10.1016/j.apmr.2013.03.014.

8. Ertzgaard P, Campo C, Calabrese A. Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. J Rehabil Med. 2017;49:193–203.

9. Elia AE et al. Botulinum neurotoxins for post-stroke spasticity in adults: a systematic review. Mov Disord. 2009 Apr 30;24(6):801-12.

10. Barnes MP, Johnson GR. Upper motor neurone syndrome and spasticity: Clinical management and neurophysiology: Cambridge University Press. 2008.

11. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236–40.

12. Meythaler JM, Guin-Renfroe S, Law C, et al. Continuously infused intrathecal baclofen over 12 months for spastic hypertonia in adolescents. Arch Phys Med Rehabil. 200;82(2):155–61.

13 Gilmartin R, Bruce D, Stoors BB, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71–7.

14. Ivanhoe CB, Francisco GE, McGuire JR, et al. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11):1509–15.

15. Coffey RJ, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78:226–32.

16. Schiess MC, Oh IJ, Stimming EF, et al. Prospective 12-month study of intrathecal baclofen therapy for poststroke spastic upper and lower extremity motor control and functional improvement. Neuromodulation. 2011;14(1):38-45.

17. SISTERS study, Medtronic data on file

18. Medtronic Product Performance Report 2016. http://professional.medtronic.com/ppr/wcm/groups/mdtcom_sg/mdt/neuro/documents/documents/mdt_product_performance_2016.pdf

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Brief StatementSee the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.com.

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