Healthcare Industry News: neurostimulator
News Release - July 11, 2011
St. Jude Medical Receives FDA Approval for Expansion of BROADEN Deep Brain Stimulation Study for DepressionResearch focuses on Brodmann Area 25 region of the brain to help patients with major depressive disorder for whom current treatments are not effective
ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for expansion of its BROADEN™ (BROdmann Area 25 DEep brain Neurostimulation) study for depression. This expansion will allow a maximum of 20 sites across the U.S. to enroll up to 125 patients.
The BROADEN study is investigating whether or not stimulating an area of the brain known as Brodmann Area 25 (BA25) with a deep brain stimulation (DBS) system is a safe and effective method for treating severe depression.
“Deep brain stimulation could potentially change the way that we look at treating patients suffering with severe depression,” said Mark George, M.D., distinguished professor of psychiatry, radiology and neurology at the Medical University of South Carolina. “Treatments such as medications, psychotherapy and electroconvulsive therapy often fail to work for these very difficult-to-treat patients, so we are hopeful this research will provide us with a new approach to treating this debilitating condition.”
The BROADEN study is a controlled, blinded study that utilizes the St. Jude Medical Libra™ deep brain stimulation system. Prior to the expansion, this study was conducted at only three centers located in Chicago, New York City and Dallas. Participants must be classified as having treatment-resistant depression and must have failed multiple treatments to be a candidate for the study.
“We are committed to leading this important research in hopes of finding a solution for people who currently don’t have a treatment option,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “By expanding the BROADEN study, we are able to continue to add to the body of evidence that will determine if deep brain stimulation is indeed an option for managing major depressive disorder.”
The BROADEN study is being conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE). St. Jude Medical will request approval to expand the study to a total of 231 patients at a later date. To locate participating centers, please visit www.BROADENstudy.com or call toll-free 866-787-4332.
To be eligible for this study, participants must:
* Have been diagnosed with major depressive disorder (MDD)
* Be between 21 and 70 years old
* Have had first depressive episode before age 45
* Have tried at least four treatments in their current episode (for example, different medications, different combinations of medications, and/or electroconvulsive therapy (ECT))
The BROADEN study builds upon an earlier St. Jude Medical pilot study which reported that at six months, 62 percent of the patients experienced at least a 40-percent decrease in symptoms of depression as measured by a standardized test called the Hamilton Rating Scale for Depression. Of these patients, 92 percent maintained this improvement at their last follow-up visit (typically at one year).
A non-pharmacological therapy, deep brain stimulation uses mild pulses of current from an implanted device to stimulate the brain. DBS leads are surgically positioned in the brain at a specific target and connected with a neurostimulator that is typically placed under the skin near the collarbone.
In the U.S., more than 21 million adults suffer from some kind of depressive disorder, according to the National Institute of Mental Health (NIMH). Of these, approximately 4 million live with severe depression that does not respond to medications, psychotherapy and, in certain cases, ECT.
Three Decades of Leading-Edge Neurostimulation Technology
For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems.
Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Clinical studies are currently underway for Parkinson’s disease, essential tremor, migraine headache, and others.
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.
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 shares. 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 April 2, 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.
Source: St. Jude Medical
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