TDD therapy for severe spasticity

   Important Safety Information

Talk to a specialist if treatments like pills or injections aren't giving you enough relief from severe spasticity. Talk to a specialist about the CE mark approved treatment option called TDD therapy

What is severe spasticity?

Severe spasticity is a condition in which tight, stiff muscles make it difficult to control your arms, legs, or body. Spasticity can cause spasms, pain, and disability. Spasticity is considered severe when it gets in the way of daily activities, sleep patterns, and caregiving.

Spasticity occurs when nerves in the brain or spinal cord that control movements are injured. Spasticity is often related to cerebral palsy, brain injury, stroke, multiple sclerosis, and spinal cord injury.

Why is treatment important?

The right treatment may make work, school, activities, and caregiving easier. It may give you greater comfort and control over your everyday tasks.

When other treatments aren't working

Many people can control spasticity with oral medication, physical and occupational therapy, or injection therapy, but some find that these treatments don't work well enough or have intolerable side effects. Consider a targeted drug delivery pump if:

• You aren't getting enough relief from other spasticity treatments.
• You're struggling with the drug side effects like drowsiness, confusion, weakness, and nausea.
• You have severe spasticity from a traumatic brain injury that occurred at least one year ago.

Safety and efficacy in patients under the age of 4 has not been established.

Why a pump is different

When medication is taken orally as a pill, most of the drug stays in the bloodstream. Only a small amount reaches the fluid surrounding the spinal cord, even at very high doses. In contrast, the pump delivers medication directly into the spinal fluid. As a result, targeted drug delivery therapy requires a fraction of oral dose, which can lead to fewer side effects. When medicine is delivered right where it is needed, you need less, which may help minimize some of the possible side effects that may accompany oral medication.^1,2

How the pump works

SynchroMed™ II pump delivers a precise amount of medication directly into the fluid that surrounds the spinal cord. This area is called the intrathecal space. A surgeon places the pump just under the skin of the abdomen. The pump is programmed wirelessly to release medication. Most patients say the pump feels comfortable and does not interfere with their day-to-day movements. The drug used in the pump for treatment of severe spasticity is prescribed by your doctor. The treatment is CE marked.

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Features

• Programmed for your needs – Your doctor programs the device to specify how much medication should be delivered. Your doctor can adjust the dose if your spasticity increases or if you have a new treatment goal. 
• Flex dosing – The pump can be programmed to vary the amount of medication up to 13 different times throughout a day, so you get more or less medication when you need it. Programming can also vary from day to day to match your scheduled activities.
• Storage of device information – The pump stores important data about your device and settings, so you do not need to carry records if you travel or change clinics. A doctor accesses the information with a clinician programming device.
• Predictable replacement – An alarm will sound before the battery runs out, so you have plenty of time to plan for replacement.
• MRI conditionally safe – The pump allows for full body MRI scans under specific conditions. Check with your doctor who can find more information on our MRI resource library.

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Explore the benefits and risks of treatment with a SynchroMed™ II Infusion Pump, and then talk with your doctor about what it might mean for you.

Less medication needed

High oral doses of prescribed medication can cause side effects such as drowsiness, confusion, dizziness, weakness, or nausea.² A TDD pump delivers prescribed medication directly to the fluid flowing around the spine. When medicine is placed right where it is needed, you need less, which may help minimize some of the possible side effects that may accompany oral prescribed medication.²

Try it first

A screening test provides you and your doctor with an opportunity to discover whether your body will respond to the treatment before you proceed with surgery.

Possible temporary side effects of the screening test include:

• Loose muscles
• Nausea/vomiting
• Sleepiness
• Headaches
• Dizziness

Programmed for your needs

Your pump will be programmed to deliver the exact dose you need at different times of the day, and can even vary the amount of prescribed medication at different times of the day. You may need more medication at night to reduce spasticity so you can sleep better, and less in the morning when spasticity is making transfers easier. Your doctor could adjust the timing of your doses to meet your needs. Programming can also vary from day to day to match your scheduled activities. For example, you might need less or more medication on the day of a physical therapy appointment.

Long-term spasticity management

Treatment with a SynchroMed™ II pump won’t cure severe spasticity or the medical condition causing it, but it may help control your spasticity long term.^3,4

Can be reversed

Therapy can be turned off by your doctor, or if desired, the pump can be surgically removed.

Proven history

Doctors have been prescribing TDD  therapy since 1992, when it was approved by the FDA in the United States. The same Medtronic pump is also used to deliver pain medication for many patients worldwide. A prescription is required.

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Patient important safety information

When receiving TDD Therapy make sure you follow your clinician’s instructions closely. A sudden stop in therapy can result in serious prescribed medication withdrawal symptoms, such as high fever, changed mental status, muscle stiffness, and in rare cases, may result in the loss of function of many vital organs and death.

It is critical that your clinician be called right away if you experience any of these symptoms. Make sure you keep your scheduled refill visits so you don’t run out of medication. You should also know the early symptoms of prescribed medication withdrawal. Some people are at more risk than others for medicine withdrawal; speak with your clinician about this.

Q: What is severe spasticity?

A: Severe spasticity is a condition that results from an injury to or disease of the brain or spinal cord. Spasticity may make your muscles feel tight, stiff and difficult to move. With severe spasticity, you can experience stiffening of the muscles that makes your muscles feel like they are locked, or even jerk uncontrollably when you try to use them.

Q: What is TDD Therapy?

A: Targeted drug delivery is a treatment using prescribed medication that is delivered into the fluid around your spinal cord (intrathecal) to help manage severe spasticity. For long term treatment, the drug is placed into a pump that is surgically placed under the skin of your abdomen. The pump delivers prescribed medication through a small tube (catheter) into your spinal fluid. Your doctor can program the pump to deliver the appropriate daily dose for you. Before you can be considered for long term treatment, you must have a test dose to see how you respond to the drug when it is delivered in this way. After the test dose is done, your doctor will discuss the results with you and determine if you are an appropriate candidate for the therapy.

Q: Who is a candidate for TDD Therapy?

A: People who have severe spasticity resulting from conditions of the brain or spinal cord (such as multiple sclerosis, cerebral palsy, stroke, brain injury or spinal cord injury) may be candidates for TDD Therapy. If your spasticity is due to spinal cord injury or multiple sclerosis and is not controlled with medication taken by mouth or you have side effects that are not acceptable from oral medication taken to treat your spasticity, you may be a candidate. If you have had a brain injury due to trauma, you should wait for one year after your injury to be considered for TDD Therapy. Safety and efficacy in patients under the age of 4 has not been established.

Q: Who is not a candidate for TDD Therapy or a screening test dose?

A: If you are hypersensitive to prescribed medication, you should not use it. If you have an active infection, you should not have a screening test or implant until the infection has resolved. You should not receive TDD Therapy if you have a body size that is too small to hold the implantable pump.

Q: What do I need to know if I am using targeted drug delivery?

A: All patients and caregivers should receive information on the risks of the treatment. Your doctor should give you information of the signs and symptoms of receiving too much or too little medication (overdose or withdrawal) and what to do if you notice those symptoms.

Q: What can I do to prevent medication withdrawal or abrupt interruption of medication?

A: It is very important that you not miss refill appointments. If you plan to travel let your doctor know so that your refill can be scheduled so that you don’t run out of medication. If you are hospitalized for any reason near the time of your refill, you or your caregiver should let your doctor know before the refill date so that arrangements can be made to refill your pump. Not all hospitals have doctors that can refill pumps, so let your doctor know as soon as possible if it is near your refill date. You should be aware of what your pump alarms sound like. If you hear an alarm, contact your doctor immediately.

Q: What are the potential pump and catheter implant procedure complications?

A: The implanted pump and catheter are placed under the skin of the abdomen during a surgery. Some complications that you may experience with the implant surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

Q: What are the potential pump and catheter complications that can occur after implant?

A: Once the infusion system (the pump and the catheter) is implanted, device complications may occur that may require surgery to remove or replace the pump, catheter or catheter fragment. Some of these device complications may impact the flow of medication delivered, which may cause symptoms of overdose or withdrawal of prescribed medication.

Possible complications include an internal component failure which may result in a loss of therapy, or an inability to program the pump. The pump, catheter or catheter fragment could migrate within the body or erode through the skin. Tissue or an inflammatory mass may form at the tip of the catheter in the intrathecal space and may cause a loss of therapy or neurological impairment including paralysis. The catheter could leak, tear or become disconnected resulting in delivery of medication into the area under the skin where the pump is implanted and/or along the catheter path. The catheter could kink or become blocked resulting in no delivery of medication. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. Errors in locating the pump during the refill procedure can result in symptoms of overdose that may be serious or life-threatening.

Q: Can I undergo Magnetic Resonance Imaging (MRI) testing?

A: Under certain conditions, an MRI can be conducted with the pump. Always inform your doctor that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy. Please ask your doctor to determine if the MRI scan can be used with the pump. The MRI will cause your pump to temporarily stop, which will suspend drug delivery during the MRI. The pump should resume normal operation and drug delivery after the MRI is complete. Your pump may also temporarily sound an alarm during the scan; the alarm should stop at the conclusion of the scan. Following your MRI, your doctor should check your pump to confirm that it is working properly.