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Deep brain stimulation: A competitor for Medtronic in America? Special

By Bill Schmalfeldt     Jan 25, 2012 in Health
It looks like Medtronic, which had the lucrative deep brain stimulation market all to itself in the U.S., may find itself with some competition.
According to news published Jan. 24 by the University of Cincinnati, there's a new kid on the block in the market for deep brain stimulation devices.
A multi-site study of the Libra and Libra XP devices, manufactured by St. Jude Medical in St. Paul, Minn., uses a different theory of stimulation to the brain than the currently FDA-approved DBS devices manufactured by Medtronic, across the Mississippi River in Minneapolis. Much like Medtronic's Kinetra DBS devices, the Libra XP can have two leads connected to it, requiring the implantation of only one neurostimulator in the chest. Like Medtronic's Soletra unit, the Libra connects to a single lead, requiring the implantation of two devices for bilateral deep brain stimulation, according to Denise Landry, Public Relations Director at St. Jude Medical.
Deep Brain Stimulation is a surgical procedure in which electrodes are inserted into the brain to stimulate the subthalamic nuclei. It has been shown in previous studies to control some of the motor symptoms of Parkinson's disease and improve quality of life for the patient. It is not a cure for Parkinson's disease.
The study was conducted by Dr. George Mandybur, an associate professor of neurosurgery at the University of Cincinnati (UC) College of Medicine and Mayfield Clinic neurosurgeon, and Dr. Fredy Revilla, an associate professor of neurology and UC Health neurologist. It was published Jan. 11, 2012, in the online edition of Lancet Neurology. Principal investigator of the study was Dr. Michael Okun, a neurologist and co-director of the Center for Movement Disorders and Neurorestoration at the University of Florida College of Medicine. He is also National Medical Director for the National Parkinson Foundation.
In a St. Jude press release
, Dr. Okun touted the study results.
"These results are important as they represent the first large, randomized, controlled study of a constant current device for managing the symptoms of Parkinson’s disease. The data from this study represents the evolution of the approach to deep brain stimulation treatment and provides new evidence supporting the positive benefits this therapy can provide patients.”
Dr. Mandybur discussed how the Libra and Libra XP devices differ from the currently available DBS devices made by Medtronic.
"This is the first study to look at constant-current effectiveness in Parkinson’s disease,” Dr. Mandybur said. "The new device appeared to be every bit as effective as the voltage-controlled device, but we won’t know for sure until there is a head-to-head comparison in future clinical trials. The devices are not identical.”
The study results likely signal the imminent arrival of a competitor into a market currently filled only by Medtronic. Mandybur said this would likely stir competition and provide motivation for others to develop new technology to treat Parkinson's disease.
Researchers suggest that constant-current stimulation could more accurately control of the spread of the electrical field than currently-used voltage-controlled stimulation devices. Writing in an accompanying editorial in Lancet Neurology, Dr. Jens Volkmann, of the University Hospital of Würzburg, Germany, said constant current stimulation has a theoretical advantage over voltage-controlled stimulation of avoiding variations in the stimulating current caused by fluctuations brain tissue interfering or impeding the current.
"Currently, there are no clinical data comparing the two methods of delivering current to brain tissue, but fundamental differences are unlikely. The electrode–tissue interface is formed within the first weeks after the surgery, and during this settling in period, changes in electrode impedance might necessitate amplitude adjustments when a constant-voltage device is used. Thereafter, clinical effects and stimulation parameters remain remarkably constant for years, irrespective of which mode of stimulation is being used," he wrote.
The St. Jude Neuromodulation Division paid for the study. Now they wait for approval from the U.S. Food and Drug Administration for the Libra and LibraXP neurostimulators.
Landry said the company will work with the FDA in order to move the approval process forward for commercialization in the U.S. "Since we need to work through the regulatory pathway, we are not able to provide you with any additional information on our regulatory timeline," she said. The devices are currently approved for use in Europe, Latin America and Australia.
(FULL DISCLOSURE: The author of this article is a Parkinson's disease patient who had Medtronic's "Soletra" DBS device implanted as part of a clinical trial at Vanderbilt University Medical Center in Nashville in 2007. The Phase 1 study was designed to investigate if patients in the earlier stages of Parkinson's could tolerate the implantation of the devices.)
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