November 8, 2006
Stroke Survivors Benefit Significantly From Targeted Spasticity Treatment Using Medtronic Drug Pump, Study Finds
A new study of stroke survivors shows that treatment delivered with an implantable drug pump from Medtronic, Inc. (NYSE:MDT) significantly improved patients' muscle tone, functional independence and quality of life.
Study participants had a condition called spasticity, a common result of strokes in which tight, stiff muscles make coordinated movement -- especially of the arms and legs -- difficult or uncontrollable. Those who received Medtronic ITB TherapySM (Intrathecal Baclofen Therapy), which uses the company's SynchroMedÃ® Programmable Pump, experienced a significant reduction in their severe spasticity, as well as significant improvements in both functional independence and quality of life, after 12 months of treatment. Importantly, the study found that patients receiving ITB Therapy did not experience a significant reduction in the strength of the limbs unaffected by their stroke -- confirming the findings of previous studies.
"Stroke survivors face a range of issues, from cognitive deficits to speech and mobility problems," said Dr. Cindy B. Ivanhoe, medical director for Mentis Neurorehabilitation in Houston and the lead author of the study, which appears in the November 2006 issue of Archives of Physical Medicine and Rehabilitation. "This research shows that spasticity is one issue that can be safely and effectively managed with ITB Therapy. With spasticity under control, many stroke survivors make better progress with their overall recovery and rehabilitation." (Dr. Ivanhoe served as director of the brain injury and stroke program at Memorial Hermann -- TIRR in Houston while the study was conducted.)
Stroke will strike approximately 750,000 Americans this year alone, of which more than 500,000 people will survive, according to National Stroke Association, which estimates the number of stroke survivors in the United States to be around 5.4 million -- and rising along with life expectancy.
"With the success of efforts aimed at preventing stroke and improving its acute care, the number of stroke survivors will continue to grow as the baby boomers reach retirement age," said James Baranski, National Stroke Association chief executive officer and executive director. "That's why stroke rehabilitation has never been more important. That's also why we are working to make stroke survivors aware of their rehabilitation options."
In the recent National Stroke Association Forgotten Stroke Survivor Survey, a majority of more than 500 stroke survivors and caregivers indicated that they lacked information on rehabilitation options. In addition, nearly three in five (58 percent) of the survivors in the survey acknowledged having experienced tight, stiff muscles post-stroke, but only half (51 percent) said that they had received treatment for it.
Supported by Medtronic, the study involved 24 U.S. stroke treatment centers and enrolled 94 patients with spasticity in at least two limbs that was significant enough to interfere with activities of daily living (ADL). It is the largest study of ITB Therapy for the treatment of post-stroke spasticity conducted to date and differs from previous studies by using function and quality of life as outcome measures.
The study evaluated spasticity, function, and quality of life after 12 months of treatment with ITB Therapy. To evaluate the efficacy of ITB Therapy, study participants had the spasticity in their upper and lower limbs measured on the Ashworth Scale, the most widely used clinical measure of spasticity. On average, upper limb spasticity decreased by 31 percent, while lower limb spasticity decreased by 42 percent. These significant reductions in spasticity led to significant improvements in function and quality of life as evaluated by the Functional Independence Measure (FIMTM) and Sickness Impact Profile (SIP), respectively.
"The magnitude of these reductions in spasticity is significant both statistically and clinically," explained Dr. Gerard Francisco, co-director of the brain injury and stroke program at Memorial Hermann -- TIRR in Houston. "For patients, it means greater range of motion and less pain, which makes basic activities of daily life easier and more enjoyable. In short, it means greater independence, which benefits patients' caregivers, too."
The most commonly reported adverse events in the trial were accidental injury (10.8 percent of participants), somnolence (9.5 percent), dizziness (9.5 percent), and hypotonia (8.1 percent). All adverse events were transient and easily managed.
"This study adds significantly to the body of clinical evidence for ITB Therapy as a treatment for severe spasticity associated with stroke," said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the company's Neurological division. "We remain committed to supporting clinical research that establishes the evidence necessary for more physicians and patients to embrace ITB Therapy and other applications of our implantable neuromodulation technology, which includes programmable infusion and neurostimulation systems."
Medtronic ITB Therapy is indicated for the management of severe spasticity of cerebral and spinal origin, including stroke, cerebral palsy, brain injury, spinal cord injury, and multiple sclerosis. It uses Medtronic's SynchroMed Implantable Infusion System, which consists of a programmable drug pump connected to a thin tube, or catheter, to deliver precise amounts of a muscle relaxant called LioresalÃ® Intrathecal (baclofen injection) directly to the intrathecal space -- the fluid-filled area surrounding the spinal cord, the drug's site of action. By targeting the spinal cord, ITB Therapy reduces spasticity with smaller amounts of medication -- 1/100th of the dose that would be required orally. Intrathecal infusion, which bypasses the body's blood-brain barrier, also minimizes systemic side-effects.
More information about ITB Therapy for the treatment of stroke-related spasticity is available online at www.YourLifeAfterStroke.com or by calling 1-800-856-3823. Other pharmaceutical treatments for spasticity include oral and injectable medications.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology -- alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
LioresalÃ® is a registered trademark of Novartis Pharmaceuticals Corporation.