Conducted at 15 medical centers in the U.S., the study enrolled 136 patients and was designed to compare patients implanted with DBS systems with and without stimulation. The primary endpoint was defined as an increase in the duration of "on time" without bothersome dyskinesia whemeasured after three months. "On time" refers to the amount of hours each day that a patient has good control of his or her symptoms and motor functions with non-bothersome dyskinesia. Dyskinesia is defined as the involuntary movements caused by medications used to manage the disease.
The results of the study were statistically significant, demonstrating that participants in the stimulation group averaged an increase of 4.27 hours of "on time," compared with an increase of 1.77 hours in the group without stimulation. Additionally, patients reported an overall improvement in their quality of life.
"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," said Michael S. Okun, MD, administrative director of the University Of Florida College Of Medicine's Center for Movement Disorders and Neuro restoration, National Medical Director for the National Parkinson Foundation and the primary author of the article. "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."
Additional key findings at three months were as follows:
Patients receiving stimulation had a 73 percent response rate compared to a 38 percent response rate in the group without stimulation (response was defined as at least a two hour increase from baseline in good quality "on time").
Motor scores for those in the stimulation group improved 39 percent compared to the baseline as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).
There was a statistically significant decrease in the amount of medications needed to control PD symptoms in the stimulation group compared to the group without stimulation.
"We are committed to furthering the science of neuromodulation in order to provide clinically relevant solutions for physicians and their patients," said Rohan Hoare, president of St. Jude Medical Neuromodulation Division. "These results confirm the benefit of our constant current deep brain stimulation device platform and lay the foundation for future therapy innovation.
" The study enrolled patients who on average had suffered from PD for at least five years and who had six or more hours each day with diminished motor symptom control and with moderate to severe dyskinesia. All patients were treated with bilateral stimulation in the subthalamic nucleus area of the brain.
The adverse event and safety profile were similar to those in other recent randomized studies of DBS. Participants in the stimulation group saw an increase in the occurrence of slurred speech and fatigue. The most common serious adverse event following DBS implantation was infection, which occurred in five patients.
The Libra and LibraXP neurostimulators evaluated in the study are constant current devices that are currently approved for use in Europe, Latin America and Australia for managing the symptoms of PD. The systems consist of a neurostimulator -- a surgically implanted battery-operated device that generates mild electrical pulses -- and leads, which carry the pulses to a targeted area in the brain.
The National Parkinson Foundation ( www.Parkinson.org estimates that in the United States, more than one million people currently have the disease with 50,000-60,000 new cases diagnosed each year. Worldwide there are approximately six million people who suffer from this condition.
Three Decades of Leading-Edge Neurostimulation Technology
For more than 30 years, St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 75,000 St. Jude Medical neurostimulation devices have been implanted in patients in 40 countries around the world. Focused on research, St. Jude Medical is currently conducting clinical studies for depression and essential tremor. For more information about these DBS studies, visit www.BROADENstudy.com and www.PowerOverET.com .
About St. Jude Medical St.
Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn., and has four major focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market share. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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