St. Jude Medical Announces First European Patient Implants of the Libra Deep Brain Stimulation Systems for Parkinson's Disease
ST. PAUL, Minn., Mar 26, 2009 (BUSINESS WIRE) ----St. Jude Medical, Inc. (NYSE:STJ) today announced the first patient implants of its Libra(R: 28.26, 0, 0%) deep brain stimulation (DBS: 23.9034, 0, 0%) system for treating the symptoms of Parkinson's disease, a progressive neurological disorder that affects a person's control over his or her movements and speech. The announcement was made at the European Association of Neurosurgical Societies and the Societe Francaise de Neurochirugie joint annual meeting in Marseille, France.
"We have initiated a limited launch of these systems in Europe and have recently completed implants in Austria, Germany and Greece," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "We look forward to expanding the availability of these systems in order to help physicians meet the needs of their patients."
First implants were performed by Professor Francois Alesch, M.D., at the Medical University of Vienna, Vienna Austria, Professor Jan Vesper, M.D., at the University of Dusseldorf, Dusseldorf, Germany, and Professor Damianos Sakas, M.D., at the Evangelismos General Hospital, Athens, Greece.
"Deep brain stimulation is a safe surgical treatment for advanced Parkinson's disease," said Dr. Alesch, a professor of Stereotactic and Functional Neurosurgery at the Medical University of Vienna. "The availability of the Libra DBS systems allows us to choose the system that best meets the needs of the individual patient."
The European Parkinson's Disease Association estimates that Parkinson's disease affects approximately 6.3 million people worldwide. The disease usually develops in people between the ages of 40 and 70, with an average age of onset of 60 years. Parkinson's disease affects both men and women in almost equal numbers.
"In properly selected patients, deep brain stimulation therapy can provide extremely good results," said Professor Alfons Schnitzler, M.D., at the University of Dusseldorf. "For these patients, DBS may reduce akinesia, rigidity, tremor and levodopa-induced motor complications resulting in a significant improvement in their quality of life."
The Libra and LibraXP(TM: 65.48, 0, 0%) neurostimulators are constant current devices and feature the highest battery capacity of any DBS devices in their class, which may maximize the time between device replacement procedures. 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 system functions in a manner similar to a cardiac pacemaker by influencing the irregular nerve signals responsible for the symptoms of Parkinson's disease. This therapy can be non-invasively adjusted by a clinician to meet individual patient needs.
The European CE Mark approvals of the Libra and LibraXP DBS systems represent the first deep brain stimulation system approvals for St. Jude Medical. Additionally, St. Jude Medical is developing other DBS applications to address a growing list of neurological disorders. DBS clinical studies are underway in the U.S. for depression, Parkinson's disease and essential tremor. For more information about these studies, visit www.BROADENstudy.com, www.PowerOverPD.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. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.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 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 3, 2009. 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, Inc.
Monday, March 30, 2009
Saturday, March 21, 2009
New Parkinson Treatment Hope
A simple and cheap device that stimulates the spinal cord with electricity could bring new hope to sufferers of Parkinson's disease, it has been claimed.
Early research in mice and rats using the approach has proved dramatically effective.
Experts believe if the technique works in humans it could provide a passport to normal living for thousands of Parkinson's patients.
The progressive disease affects motor nerves in the brain, causing tremors, loss of balance and muscle stiffness.
Drugs can reduce symptoms in the early stages but then cease to be effective.
Around 120,000 people in the UK suffer from Parkinson's, with 10,000 new cases diagnosed each year.
One radical remedy for the condition is deep brain stimulation (DBS), which involves inserting carefully placed electrodes deep into the brain. But the treatment is costly, invasive and not suitable for everyone.
The new stimulation therapy, targeting the spinal cord instead of the brain, would be much easier and cheaper to administer.
Professor Miguel Nicolelis, from Duke University in North Carolina, who led the research described in the journal Science, said: "We see an almost immediate and dramatic change in the animal's ability to function when the device stimulates the spinal cord.
"Moreover, it is easy to use, significantly less invasive than other alternatives to medication, such as deep brain stimulation, and has the potential for widespread use in conjunction with medications typically used to treat Parkinson's disease."
Copyright © 2009 The Press Association. All rights reserved.
Early research in mice and rats using the approach has proved dramatically effective.
Experts believe if the technique works in humans it could provide a passport to normal living for thousands of Parkinson's patients.
The progressive disease affects motor nerves in the brain, causing tremors, loss of balance and muscle stiffness.
Drugs can reduce symptoms in the early stages but then cease to be effective.
Around 120,000 people in the UK suffer from Parkinson's, with 10,000 new cases diagnosed each year.
One radical remedy for the condition is deep brain stimulation (DBS), which involves inserting carefully placed electrodes deep into the brain. But the treatment is costly, invasive and not suitable for everyone.
The new stimulation therapy, targeting the spinal cord instead of the brain, would be much easier and cheaper to administer.
Professor Miguel Nicolelis, from Duke University in North Carolina, who led the research described in the journal Science, said: "We see an almost immediate and dramatic change in the animal's ability to function when the device stimulates the spinal cord.
"Moreover, it is easy to use, significantly less invasive than other alternatives to medication, such as deep brain stimulation, and has the potential for widespread use in conjunction with medications typically used to treat Parkinson's disease."
Copyright © 2009 The Press Association. All rights reserved.
Saturday, March 14, 2009
Nanotech coating could lead to better brain implants to treat diseases
ANN ARBOR, Mich.---Biomedical and materials engineers at the University of Michigan have developed a nanotech coating for brain implants that helps the devices operate longer and could improve treatment for deafness, paralysis, blindness, epilepsy and Parkinson's disease.
Currently, brain implants can treat Parkinson's disease, depression and epilepsy. These and the next generation of the devices operate in one of two ways. Either they stimulate neurons with electrical impulses to override the brain's own signals, or they record what working neurons are transmitting to non-working parts of the brain and reroute that signal.
On-scalp and brain-surface electrodes are giving way to brain-penetrating microelectrodes that can communicate with individual neurons, offering hope for more precise control of signals.
In recent years, researchers at other institutions have demonstrated that these implanted microelectrodes can let a paralyzed person use thought to control a computer mouse and move a wheelchair. Michigan researchers' say their coating can most immediately improve this type of microelectrode.
Mohammad Reza Abidian, a post-doctoral researcher in the Department of Biomedical Engineering who is among the developers of the new coating, says the reliability of today's brain-penetrating microelectrodes often begins to decline after they're in place for only a few months.
"You want to be able to use these for at least a couple years," Abidian said. "Current technology doesn't allow this in most cases because of how the tissues of the brain respond to the implants. The goal is to increase their efficiency and their lifespans."
The new coating Abidian and his colleagues developed is made of three components that together allow electrodes to interface more smoothly with the brain. The coating is made of a special electrically-conductive nanoscale polymer called PEDOT; a natural, gel-like buffer called alginate
Currently, brain implants can treat Parkinson's disease, depression and epilepsy. These and the next generation of the devices operate in one of two ways. Either they stimulate neurons with electrical impulses to override the brain's own signals, or they record what working neurons are transmitting to non-working parts of the brain and reroute that signal.
On-scalp and brain-surface electrodes are giving way to brain-penetrating microelectrodes that can communicate with individual neurons, offering hope for more precise control of signals.
In recent years, researchers at other institutions have demonstrated that these implanted microelectrodes can let a paralyzed person use thought to control a computer mouse and move a wheelchair. Michigan researchers' say their coating can most immediately improve this type of microelectrode.
Mohammad Reza Abidian, a post-doctoral researcher in the Department of Biomedical Engineering who is among the developers of the new coating, says the reliability of today's brain-penetrating microelectrodes often begins to decline after they're in place for only a few months.
"You want to be able to use these for at least a couple years," Abidian said. "Current technology doesn't allow this in most cases because of how the tissues of the brain respond to the implants. The goal is to increase their efficiency and their lifespans."
The new coating Abidian and his colleagues developed is made of three components that together allow electrodes to interface more smoothly with the brain. The coating is made of a special electrically-conductive nanoscale polymer called PEDOT; a natural, gel-like buffer called alginate
Saturday, March 7, 2009
Helping Parkinson's disease sufferers live a better life
Parkinson's disease affects an estimated one in every 500 people in Europe – it is the second most common disease after Alzheimer's. With so many afflicted, one research team is trying to help people with Parkinson’s living at home to overcome the social exclusion its symptoms can cause.
A degenerative disease of later life with widely varying symptoms, Parkinson's disease (PD) can result in poor mobility or paralysis, speech disorders and depression, causing people to drop out of life's flow. It is an idiopathic disease, and researchers suspect both genetic causes and environmental pollution as contributory factors.
Partners in the ParkService initiative co-funded by the European Commission’s eTEN programme are testing a set of services that could help sufferers better manage the disease symptoms. This eInclusion project, which began in August 2004 and ends 31 March 2007, involves research institutes in four countries, Italy, Germany, the UK and Greece, in testing three prototype services.
A fascinating online video shows a stooped man with Parkinson's disease shuffling with difficulty across an apartment. After briefly observing a line of rectangles of white paper lined up on the floor before him, he can suddenly stand up straight and walk briskly over the paper trail. But at the end of the paper trail, the man stoops again and resumes shuffling.
The video demonstrates how visual markers known as ‘cues’, like these simple pieces of paper, can help people with Parkinson's disease do things that their damaged neuromotor libraries have made much more difficult, says Reynold Greenlaw at UK-based Oxford Computer Consultants Ltd., coordinator of the eTEN co-funded ParkService project.
Virtual pieces of paper
ParkService is "testing the European market for a device that lets a person with Parkinson's see the virtual equivalent of those pieces of paper, wherever he walks," says Greenlaw. That device, called INDIGO, is the core of ParkService's prototype set of telematic tools, which aim to help PD patients to live and communicate with both clinicians and others.
INDIGO is a pair of virtual-reality eyeglasses equipped with electronics and a rechargeable battery, and a belt-or pocket worn mini-computer that can be configured remotely. "A monitor in the glasses puts moving stripes in the person's peripheral vision, providing that helpful visual cue," says Greenlaw.
Originally named ParkWalker, the INDIGO eyeglasses won the European Commission’s Assistive Technology Award in November 2004. They were originally developed under an earlier IST-sponsored project, PARREHA, which lead to the setting up of a joint company, ParkAid, which is the motor of the ParkService consortium.
ParkLine, another mature prototype, will give patients a secure, easy-to-use way to use their televisions to communicate with their physicians and other disease sufferers. They can type in symptom diaries using a television remote control or send video from a webcam. ParkLine is designed to keep bandwidth low in order to keep costs down.
Greenlaw says that, "We received positive feedback on ParkLine following a group presentation at the Schneckenhaus, a large group home in Germany for people with Parkinson's. Now we're working on interface customisations that people have asked for, like language and bigger buttons on the remote control."
The browser-based ParkClinic tool allows doctors to receive ParkLine messages and images from their patients. "This is the system's least challenging part. Doctors have tried it at the Institute of Neurology, but not formally," says Greenlaw.
Rollout planned for 2007
The INDIGO system costs 2,000 euros. ParkService support will be paid for in a variety of ways. "In Germany private-health insurance and patient organisations may pay for it. In the UK we will try to get backing from the National Health Service, and in Italy, patient organisations will pay," explains Greenlaw.
ParkService is a market validation project, and rollout is set for March 2007. "We'll start in Germany, because they have a unified structure for dealing with people with Parkinson's, as well as a very developed internet infrastructure and Europe's largest population," says Greenlaw.
"For now, our objective is to use feedback from the ParkService pilots to fine-tune the tools. Then, our next step is to get them into people's homes and doctors' offices in larger numbers," says Greenlaw.
Source: Based on information from PARKSERVICE
A degenerative disease of later life with widely varying symptoms, Parkinson's disease (PD) can result in poor mobility or paralysis, speech disorders and depression, causing people to drop out of life's flow. It is an idiopathic disease, and researchers suspect both genetic causes and environmental pollution as contributory factors.
Partners in the ParkService initiative co-funded by the European Commission’s eTEN programme are testing a set of services that could help sufferers better manage the disease symptoms. This eInclusion project, which began in August 2004 and ends 31 March 2007, involves research institutes in four countries, Italy, Germany, the UK and Greece, in testing three prototype services.
A fascinating online video shows a stooped man with Parkinson's disease shuffling with difficulty across an apartment. After briefly observing a line of rectangles of white paper lined up on the floor before him, he can suddenly stand up straight and walk briskly over the paper trail. But at the end of the paper trail, the man stoops again and resumes shuffling.
The video demonstrates how visual markers known as ‘cues’, like these simple pieces of paper, can help people with Parkinson's disease do things that their damaged neuromotor libraries have made much more difficult, says Reynold Greenlaw at UK-based Oxford Computer Consultants Ltd., coordinator of the eTEN co-funded ParkService project.
Virtual pieces of paper
ParkService is "testing the European market for a device that lets a person with Parkinson's see the virtual equivalent of those pieces of paper, wherever he walks," says Greenlaw. That device, called INDIGO, is the core of ParkService's prototype set of telematic tools, which aim to help PD patients to live and communicate with both clinicians and others.
INDIGO is a pair of virtual-reality eyeglasses equipped with electronics and a rechargeable battery, and a belt-or pocket worn mini-computer that can be configured remotely. "A monitor in the glasses puts moving stripes in the person's peripheral vision, providing that helpful visual cue," says Greenlaw.
Originally named ParkWalker, the INDIGO eyeglasses won the European Commission’s Assistive Technology Award in November 2004. They were originally developed under an earlier IST-sponsored project, PARREHA, which lead to the setting up of a joint company, ParkAid, which is the motor of the ParkService consortium.
ParkLine, another mature prototype, will give patients a secure, easy-to-use way to use their televisions to communicate with their physicians and other disease sufferers. They can type in symptom diaries using a television remote control or send video from a webcam. ParkLine is designed to keep bandwidth low in order to keep costs down.
Greenlaw says that, "We received positive feedback on ParkLine following a group presentation at the Schneckenhaus, a large group home in Germany for people with Parkinson's. Now we're working on interface customisations that people have asked for, like language and bigger buttons on the remote control."
The browser-based ParkClinic tool allows doctors to receive ParkLine messages and images from their patients. "This is the system's least challenging part. Doctors have tried it at the Institute of Neurology, but not formally," says Greenlaw.
Rollout planned for 2007
The INDIGO system costs 2,000 euros. ParkService support will be paid for in a variety of ways. "In Germany private-health insurance and patient organisations may pay for it. In the UK we will try to get backing from the National Health Service, and in Italy, patient organisations will pay," explains Greenlaw.
ParkService is a market validation project, and rollout is set for March 2007. "We'll start in Germany, because they have a unified structure for dealing with people with Parkinson's, as well as a very developed internet infrastructure and Europe's largest population," says Greenlaw.
"For now, our objective is to use feedback from the ParkService pilots to fine-tune the tools. Then, our next step is to get them into people's homes and doctors' offices in larger numbers," says Greenlaw.
Source: Based on information from PARKSERVICE
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