This story recounts the experience of one individual who is receiving ITB Therapy.SM Medtronic invited him to share his story candidly. Please bear in mind that the experience is specific to this particular person. Not everyone who receives ITB Therapy will receive the same results as the patient in this story. Talk with your doctor to determine if ITB Therapy is right for you.
In 2000, Ed experienced a hemorrhagic stroke caused by bleeding into the brain from arteriovenous malformations (AVM), which are masses of abnormal blood vessels. The condition had been treated, and he was recovering well – until one morning in January 2003, when a blood clot traveled from his heart to his brain, causing an ischemic stroke and severe weakness on his left side. Ed found it difficult to get dressed and knew he needed help immediately.
After a month in the hospital, Ed was transferred to a rehabilitation facility where he underwent intensive physical and occupational therapy before returning home.
"The spasticity remained and it was extremely painful," recalls Ed. "It was like having a constant charley horse. I was able to walk, but the spasticity affected my gait."
Ed had been given injection therapy for spasticity in his upper arm, but the effect would diminish in 90 to 120 days. When Ed's doctor suggested ITB Therapy (a Medtronic baclofen pump), Ed was receptive.
Living with ITB Therapy
ITB Therapy uses a programmable pump placed just under the skin of the abdomen. The pump is connected to a thin, flexible catheter that delivers a liquid form of baclofen directly into the area where fluid flows around the spinal cord, called the intrathecal space.
Before getting the pump, Ed needed to have a screening test to see if the liquid baclofen would relieve his symptoms.
"During the screening test, my left foot made full contact with the floor for the first time since the stroke," says Ed. "Because I had more foot surface on the floor, I could put more weight on my leg and so I was sturdier. The change in my gait – for the better – was noticeable." Ed had the pump surgically placed in December 2004.
While Ed still has spasticity, it has been significantly reduced. He feels steadier on his feet. He is confident about spending time unsupervised while his wife and family caregiver, Andrea, works.
Ed didn't experience any complications with his surgery. However, some people do experience surgical complications, side effects of the drug, or both. There are risks associated with ITB Therapy. Some of these risks include meningitis, spinal fluid leak, infection, paralysis, headache, swelling, bleeding, and bruising. Drug-related side effects may include loose muscles, drowsiness, nausea/vomiting, headache, and dizziness.
"Ed has more energy and his movements are freer with the pump," says Andrea. "I feel better going to work knowing he's comfortable staying home alone."
Ed also attributes his increased productivity in physical therapy to ITB Therapy. "Because ITB Therapy has reduced my spasticity, I stretch better and am developing more range of motion. I look forward to getting more ability as time goes by."
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Important Safety Information – ITB Therapy
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.