Intrathecal Baclofen Therapy for Severe Spasticity

The templates below are provided as samples for Non-Medtronic sponsored clinician events. Clinicians interested in hosting events with Medtronic involvement should contact their Medtronic representative to ensure co-marketing policies are followed when appropriate.

Practice Management

The ITB TherapySM (Intrathecal Baclofen Therapy) New Center Kit provides resources to support clinicians interested in incorporating ITB Therapy into their spasticity management programs. The tool provides best practice guidelines for all steps of the process from evaluation to long-term management, and includes appendix pages with sample forms, documents, and protocols.

A template to advertise about a health seminar for severe spasticity (black & white version).

A template to advertise about a health seminar for severe spasticity (color version).

A template flyer to market a health seminar with your patients for severe spasticity (black & white version).

A template flyer to market a health seminar with your patients for severe spasticity (color version).

A template brochure.

A series of three template letters.

A template to invite your physician peers to dinner events about ITB Therapy (black & white version).

A template to invite your physician peers to dinner events about ITB Therapy (color version).

A template to invite your physician peers to dinner events about treatment options for severe spasticity (black & white version).

A template to invite your physician peers to dinner events about treatment options for severe spasticity (color version).

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Referral Development

A template letter to introduce yourself and your practice to local referring clinicians.

A template letter to send following a referral event to thank clinicians for attending.

A template letter to send following a PT/OT referral event to thank attendees and invite them to refer spasticity patients to your practice.

A template invitation for a referral event.

A template invitation for a referral event.

A template invitation for a referral event.

A template invitation for a referral event.

For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review the device brief summaries for the SynchroMed II Drug Infusion System and the SynchroMed EL Infusion System.

ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

Indications, Safety & Warnings for ITB Therapy: Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.

The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

Please refer to the full prescribing information and system information for details or call Medtronic at 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

January 2008