This brochure is intended for medical doctors willing to present Intrathecal Baclofen Therapy as a treatment option to patients that have been identified as candidates.

TREATING SEVERE SPASTICITYWITH INTRATHECAL BACLOFEN (ITB) THERAPYSM

Ian M. ITB Therapy Patient

Clyde M. ITB Therapy Patient

Spasticity is caused by an imbalance of signals from the central nervous system (brain and spinal cord) to the muscles. Spasticity can be of:

Cerebral origin (e.g. stroke, traumatic brain injury, cerebral palsy)

Spinal origin (e.g. spinal cord injury, multiple sclerosis)

Spasticity affects an estimated 12 million people worldwide.1

Your muscles are tight and stiff, making movement difficult or uncontrollable.

You have painful muscle spasms that interfere with activities of daily living.

UNDERSTANDING SPASTICITY

RECOGNIZING SPASTICITY

LEGS

WRISTS

ARMS

FEET

RECOGNIZING THE SIGNS

*Treatment options are not mutually exclusive and are often used in conjunction with each other.+ Surgery can be performed to the bones, tendons, muscles to release conditions arising from spasticity

(for example contractures) or to the nervous system to treat spasticity itself.‡ Indicated for severe spasticity

While there is no cure, spasticity is a symptom that often can be managed.

You have tried several treatments* and your symptoms still impact your quality of life?

TREATING SPASTICITY

ORAL MEDICATION

PHYSICALTHERAPY

SURGERY+INJECTIONS

INTRATHECAL BACLOFEN THERAPY‡

Intrathecal Baclofen Therapy (ITB Therapy) is a treatment option worth discussing with your doctor.

88% OF PATIENTS report in one survey that their quality of life improved with ITB Therapy.2

ORAL: Systemic delivery through the circulatory system.

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

WHAT IS INTRATHECAL BACLOFEN THERAPY?

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

Requires 100 to 1000x smaller doses less medication than oral baclofen.3

(since it does not circulate throughout body)

Expected to produce fewer or more tolerable side effects as compared to oral baclofen.4-5

FROM THEORY TO PRACTICE

HOW DOES INTRATHECAL BACLOFEN THERAPY WORK?

One important advantage of ITB Therapy is that it starts with a test dose.

A THERAPY IN 2 PHASES

A standard test dose (screening test) determines if ITB Therapy may work for you.

A small quantity of liquid medication is injected directly to the fluid around the spinal cord using a syringe or a temporary catheter connected to an external pump.

The medication takes 30 minutes to 1 hour to begin to relax your muscles. Maximum effect is seen at approximately 4 hours. Effects typically last 4 to 8 hours.

A medical team carefully monitors and assesses what effect the medication is having on you.

After the test, the effects of the medication will gradually disappear. You will return to the same level of spasticity that you had before the test.

More than 9 out of 10 patients respond positively to the test dose.4-7, 12

If you and your medical team decide ITB Therapy is right for you, a programmable drug Infusion System (pump and catheter), will be implanted under your skin for long term management of your spasticity symptoms.

1

2

Results vary and not every patient will receive the same benefits.

ITB Therapy can help you improve function, activities of daily living, and ease of care through more independence, comfort and / or mobility depending on your condition and treatment goals.4-5, 7-18

Patients and caregivers report high rates of satisfaction with ITB Therapy.

BENEFITS OF INTRATHECAL BACLOFEN THERAPY

Up to 94% of patients would agree to pump implantation again.19

More than 88% of caregivers would recommend ITB

Therapy to others.20

94% 88%

Like more than 60,000 patients across the world since 1992, you carry a Programmable Drug Infusion System.

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

Attend scheduled visits for refills and prescription adjustments.

Have your pump replaced after 7 years.21 An alarm is activated 90 days before battery life ends, leaving 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 which could be the result of under or over-infusion.

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

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

LIVING WITH INTRATHECAL BACLOFEN THERAPY

Matt ITB Therapy Patient

Cindy H. ITB Therapy Patient

The most common side effects of ITB Therapy are related to the drug itself and include drowsiness, somnolence, nausea, and vomiting.22 *

Drug delivery parameters can be adjusted to minimize side effects.

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

Surgical complications are possible and include infection, bruising, bleeding, swelling, spinal fluid leak, and headache.

Once the the pump and the catheter are implanted, device complications may occur that require surgery to resolve.

POSSIBLE SIDE EFFECTS OF INTRATHECAL BACLOFEN THERAPY

PROCEDURE AND SYSTEM RELATED RISKS

* Please refer to the medicinal product’s patient information leaflet for a complete list of adverse events.If you get 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.

NOTES

www.medtronic.eu

Europe Medtronic International Trading Sàrl.Route du Molliau 31Case postaleCH-1131 TolochenazTel: +41 (0)21 802 70 00Fax: +41 (0)21 802 79 00

UC201607999EE ©2016 Medtronic. All rights reserved. Printed in Europe.

BRIEF STATEMENTSee the device manual for detailed information regarding the implant procedure, contraindications, warnings, precautions and potential adverse events.

DISCLAIMERThis information is designed to help you learn more about Intrathecal Baclofen Therapy. It is intended to provide you with helpful information but is for information purposes only, is not medical advice and should not be used as an alternative to speaking with your doctor. Be sure to discuss questions specific to your health and treatments with a healthcare professional. For more information please speak to your healthcare professional.

If you get 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.

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Treatments/Spasticity.aspx. Accessed November 20152. Staal C, Arends A, Ho S. A self-report of quality of life of patients receiving intrathecal baclofen therapy. Rehabilitation Nursing 2003;28:159–163.3. Barnes MP, Johnson GR. Upper motor neurone syndrome and spasticity: Clinical management and neurophysiology: Cambridge University

Press, 2008.4. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240. 5. Meythaler JM, Guin-Renfroe S, Law C, et al. Continuously infused intrathecal baclofen over 12 months for spastic hypertonia in adolescents

adults with cerebral palsy. Arch Phys Med Rehabil 2001;82(2):155-1616. Gilmartin R, Bruce D, Stoors BB, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol.

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quality of life. Arch Phys Med Rehabil. 2006;87(11):1509-1515. 8. Albright AL, et al. Continuous intrathecal baclofen infusion for spasticity of cerebral origin. JAMA 1993; 270 (20): 2475-2477. 9. Rawlins P. Intrathecal baclofen for spasticity of cerebral palsy: project coordination and nursing care. AJNN 1995; 27 (3): 157-163.10. Loubser PG, et al. Continuous infusion of intrathecal baclofen: long-term effects on spasticity in spinal cord injury. Paraplegia 1991: 29: 48-64.11. Parke B, et al. Functional outcome following delivery of intrathecal baclofen. Arch Phys Med Rehabil 1989; 70: 30-32.12. Coffey RJ, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg 1993; 78:

226-232.13. 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): 16-24.14. Dario A, et al. Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion. Funct Neurol

2001; 16: 311-315.15. 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: 35-39.16. Stempien L, Tsai T. Intrathecal baclofen pump use for spasticity: a clinical survey. Am J Phys Med Rehabl 2000; 79 (6): 536-541.17. Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol 1997;

244: 160-166.18. Meythaler JM, et al. Intrathecal baclofen for spastic hypertonia from stroke. Stroke 2001; 32: 2099-2109.19. Sadiq SA, Wang GC. Long-term intrathecal baclofen therapy in ambulatory patients with spasticity J Neurol (2006) 253 : 563–569.20. Campbell WM, Ferrel A, McLaughlin JF et al. Long-term safety and efficacy of continuous intrathecal baclofen. Dev Med Child Neurol.

2002;44(10):660-665.21. Medtronic Product Performance Report 2014. Accessed April 2016. http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@

neuro/documents/documents/mdt_product_performance_2014.pdf22. Plassat R, Perrouin Verbe B, Menei P, Menegalli D, Mathé JF, Richard I. Treatment of spasticity with intrathecal Baclofen administration: long-term

follow-up, review of 40 patients. Spinal Cord (2004) 42, 686–693.