Questions and Answers – ITB Therapy
How does the Medtronic SynchroMed® Programmable Drug Infusion System pump work?
The SynchroMed Drug Infusion System includes a programmable pump and catheter that are surgically placed under the skin of the abdomen. The system delivers a liquid form of the drug baclofen (Lioresal® Intrathecal) directly to the fluid around the spinal cord.
Most people report that the programmable pump is not uncomfortable or restrictive, and does not interfere with their movement. Depending on your body type and the clothes you choose, it may not show at all.
If oral baclofen didn't work for me, why would intrathecal baclofen work?
Because the drug is delivered directly to where its needed in the spinal fluid, it relieves spasticity with smaller amounts of medication than when baclofen is taken orally. This method of delivery may help minimize some of the possible side effects that may accompany oral baclofen.
Mary Elizabeth Nelson, a nurse practitioner with 8 years of working with patients who have baclofen pumps, describes the difference between oral baclofen and intrathecal baclofen.
Will ITB TherapySM cure my spasticity?
While Medtronic ITB Therapy (the baclofen pump) won't eliminate the primary source of your condition or cure your disease, it may help you manage your severe spasticity symptoms and might allow you to participate in daily activities that have become difficult or impossible.
Am I a candidate for ITB Therapy?
Candidates for Medtronic ITB Therapy (the baclofen pump) must:
- Have severe spasticity that interferes with function, care and comfort, or activities of daily living
- Show a positive response to Lioresal® Intrathecal (baclofen injection) in a standard screening test
- Have sufficient body size to support the pump; the pump must be implanted 2.5 cm (1 inch) or less from the surface of the skin
- Not have any infection
- Not be allergic to baclofen
- For spasticity of spinal cord origin, be unresponsive to oral baclofen therapy or experience intolerable side effects at effective doses
- For spasticity due to traumatic brain injury, wait one year after the injury
In addition, healthcare professionals may use the following criteria to determine if you are a candidate for ITB Therapy:
- Severe spasticity or spasms that interfere with function or daily activities
- Severe spasticity or spasms that interfere with care or positioning
Can I talk with someone who already receives ITB Therapy about their experience with the procedure and the therapy?
The ITB Therapy Ambassador Program can connect you with a patient volunteer who receives ITB Therapy and is available to share his or her experience with you.
Why should I choose a Medtronic device over another option?
When choosing a device to manage your severe spasticity symptoms, look to a healthcare company that understands your condition and has extensive experience offering safe and effective therapies.
Here are some important facts for you to consider:
- Medtronic has more intrathecal therapy experience than any other company
- Medtronic ITB Therapy is the only intrathecal therapy backed by 20 years of severe spasticity management experience
- Explore the proven benefits of Medtronic ITB Therapy
- More than 60,000 Medtronic SynchroMed® pumps have been implanted worldwide for Medtronic ITB Therapy
- The quality, reliability, and strength of the new Medtronic Ascenda™ catheter may reduce complications caused by kinks, breaks, and leaks – even during active daily living
- For more than 15 years Medtronic has collaborated with numerous advocacy groups to help raise awareness of spasticity and the conditions that can cause it
- Medtronic is the only company to track product performance, including more than 17,000 neurological devices and more than 6,100 patients
- Your Medtronic infusion system can be programmed and refilled in clinics across the United States and around the world
The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.
IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs and death. It is very important that your doctor be called right away if you experience any of the above symptoms.
It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.
The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.
The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced, or if there is a problem with the pump. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.
For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.
This therapy is not for everyone. Please contact your doctor. A prescription is required.
Lioresal® is a registered trademark of Medtronic, Inc.
USA Rx Only Rev 0913
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
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