• What is ITB Therapy^SM?
• ITB is an Effective Therapy to Reduce Spasticity
• ITB Therapy^SM is Superior to Oral Medication 
• What You Can Do Today
• Possible Side Effects and Risks

What is ITB Therapy^SM?

Intrathecal baclofen (ITB) therapy delivers drugs directly to the cerebrospinal fluid (CSF) in the intrathecal space via a catheter and an implanted programmable pump.

ITB is an effective therapy to reduce spasticity

ITB therapy^SM has been proven to significantly reduce spasticity in both lower and upper limbs, as measured by (modified) Ashworth scale (-1.5 and -1.0, p<0.01) after one year of treatment.^4,5

ITB therapy^SM is proven to significantly improve function and quality of life of patients (p<0.05).^4,5

ITB therapy^SMimproves muscle strength in the spasticity-affected limbs and does not alter the strength in the unaffected limbs.^4,5

73% of patients are satisfied with spasticity reduction and would recommend the therapy.⁶

ITB THERAPY^SM is superior to oral medication

ITB therapy^SM shows superior efficacy in reducing spasticity of lower and upper limbs vs. oral antispasticity medication as measured by Ashworth scale. Lower -1 vs. -0.4 CMM; upper -0.7 vs. -0.2 CMM (p<0.05).⁷

ITB therapy^SM shows also superior efficacy in improving actual pain (ITB -1.17 vs CMM 0.00, p<0.05) and quality of life (EQ-5D utility score, ITB 0.09 vs CMM 0.01, p<0.05).⁶

WHAT YOU CAN DO TODAY

Work as an interdisciplinary team

Actions

• Recognise the signs of spasticity
• Provide early information to patients and caregiver about spasticity
• Identify patients with spasticity
• Test the patient or refer to a specialist
• Refer the patient for implantation of pump system
• Implant SynchroMed™ II pump
• Titration and follow up of ITB therapy^SM

Possible side effects and risks

Possible side effects of ITB therapy^SM

The most common side effects of ITB therapy^SM are related to the drug itself and include muscular weakness, hypotonia, urinary retention, falls, somnolence and dizziness.

Drug delivery parameters can be adjusted to minimise side effects.

The pump can be removed to return to the patient’s initial level of spasticity.

Procedure and system-related risks

Surgical complications are possible and include headaches, intracranial hypotension, spinal fluid leak and implant site infection.

Once the pump and the catheter are implanted, device complications (e.g., device dislocation, cathether occlusion) may occur that require surgery to resolve.⁷

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

Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader® with the browser.

Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.

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