Archive for September 7th, 2012

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Barco Conference CloneView Software for Accurate Medical Projection Image Reproduction

Barco Conference CloneView Software for Accurate Medical Projection Image Reproduction

Barco Conference CloneView Software for Accurate Medical Projection Image Reproduction

Kortrijk, Belgium, 6 September 2012 – Healthcare imaging specialist Barco announces the release of Conference CloneView for projecting high-quality medical images onto a large-screen display. The new software tool ensures accurate and flexible projection configurations for a host of applications in teaching hospitals, auditoriums and (tele)conference rooms.

Flexible conferencing

Conference CloneViewTM allows medical professionals to clone outputs from one or two medical displays onto any display or projector attached to the same graphics board. The cloned image is downscaled using an algorithm designed such that all pixels contribute to the final projected image. The tool also allows zooming and panning for ease of viewing and provides the option to preserve the aspect ratio, or stretch the image.

Large-screen accuracy

“We know healthcare imaging requires the most accurate display solutions,” comments Becky Kiichle, Product Manager Display Controllers at Barco. “Conference CloneViewTM provides medical professionals, medical students and multi-disciplinary teams with simple access to precise X-ray images, MR scans, CT scans, endoscopy images, etc. on the large screen so they can get the best training and share accurate information.”

Different outputs, one view

The new tool is available as a software feature with Barco’s MXRT medical display controllers, which have been designed to deliver the performance, quality and stability required for today’s 2D and 3D imaging applications in healthcare. Using the MXRT boards for triple-head imaging, CloneView can combine two display outputs into one output signal and feed it to the projector. The software runs on Microsoft Windows® 7.

As part of Barco’s system approach, all MXRT display controllers have been fully tested and optimized to work with Barco’s full range of Nio and Coronis display products as well as its MediCal QAWeb software solution. Vigorous compatibility testing also ensures reliable performance with the latest workstations and with the leading PACS applications.

About Barco

Barco, a global technology company, designs and develops visualization products for a variety of selected professional markets. Barco has its own facilities for Sales & Marketing, Customer Support, R&D and Manufacturing in Europe, North America and Asia Pacific. Barco (NYSE Euronext Brussels: BAR) is active in more than 90 countries with more than 3,700 employees worldwide. Barco posted sales of 1.041 billion euro in 2011.

Video projectors have become popular tools when teaching medical students and for sharing case studies with clinical colleagues. This presents all sorts of issues for proper image reproduction because simply swapping a monitor for a projector makes things look quite different.

In response, Barco has released its new Conference CloneView software tool that copies up to two signals from a compatible graphics card and appropriately downscales or zooms the image for more appropriate display on a projector screen.

From the press release:

Conference CloneViewTM allows medical professionals to clone outputs from one or two medical displays onto any display or projector attached to the same graphics board. The cloned image is downscaled using an algorithm designed such that all pixels contribute to the final projected image. The tool also allows zooming and panning for ease of viewing and provides the option to preserve the aspect ratio, or stretch the image.

The new tool is available as a software feature with Barco’s MXRT medical display controllers, which have been designed to deliver the performance, quality and stability required for today’s 2D and 3D imaging applications in healthcare. Using the MXRT boards for triple-head imaging, CloneView can combine two display outputs into one output signal and feed it to the projector. The software runs on Microsoft Windows® 7.

Source : http://www.barco.com/ru/News/Press-releases/

www.new-barco-software-tool-facilitates-accurate-projection-of-large-scale-medical-images.aspx

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Synergy Pocket Circulatory Assist Device Does Well in Early Trial

Synergy Pocket Circulatory Assist Device Does Well in Early Trial

Synergy Pocket Circulatory Assist Device Does Well in Early Trial

CircuLite® is developing disruptive solutions to improve the treatment of chronic heart failure. The Company’s minimally-invasive circulatory support systems are intended to work in conjunction with the heart to enhance clinical outcomes and improve quality of life for patients and their families. The SYNERGY® surgical system for partial circulatory support, which has received CE Mark approval in Europe, features the world’s smallest surgically implanted blood pump designed for long-term use in patients diagnosed with chronic heart failure. Next-generation circulatory support systems in development that incorporate CircuLite’s micro-pump technology include an endovascular system, a right-heart system, a pediatric system, and an all-support system.

CircuLite’s devices are being developed for patients with chronic heart failure who are not responding to standard medical care, but are not candidates or eligible for heart transplantation. The majority of these patients will have been diagnosed with NYHA Class IIIb/early Class IV (INTERMACS 4-6) heart failure. SYNERGY is a miniature ventricular support system that is intended to offer patients clinical benefits over standard medical therapies, including reduced symptoms of heart failure and associated re-hospitalizations, as well as to improve exercise tolerance and quality of life.

SYNERGY’s Micro-pump is the size of a AA battery, provides up to 4.25 liters of blood flow per minute, and is designed to reduce the heart’s workload while improving blood flow to vital organs. SYNERGY supplements the heart’s native pumping capacity and preserves its ability to respond to the patient’s cardiac output demands. The system is surgically implanted using a mini-thoracotomy and the Micro-pump is placed in a pacemaker-like pocket.

CircuLite, a private, venture-backed international company, was founded 2004. CircuLite, Inc. Is headquartered in Saddle Brook, New Jersey. CircuLite GmbH, a wholly owned subsidiary of CircuLite Inc., is located in Aachen, Germany.

For a patient with end-stage heart failure, an implantable pump that helps circulate the blood can mean added months or even years of life. Now CircuLite is developing an implantable pump that weighs just one-sixth as much as its smallest predecessor. About the size of a AA battery, it could ultimately be implanted through a catheterization procedure that is far less invasive than the operations used to place today’s pumps. It could thus be used to treat patients in earlier stages of heart failure, for whom implantation surgery had previously been too risky.

Invented more than two decades ago, the earliest support pumps–or ventricular assist devices (VADs)–kept patients tethered to a large external console and a blood-thinning machine. A second generation of VADs, still widely in use, has spinning rotors that continuously draw in blood. Third-generation devices are much smaller, using magnetic or hydrostatic forces to float the rotor within the blood. That eliminates friction between the pump’s parts, which in earlier generations led to breakdowns and blood clots. But implanting these devices still requires sawing through the breastbone and placing the patient on heart-lung bypass.

CircuLite’s pump, called Synergy, uses a combination of magnetic and hydrostatic forces to suspend the rotor. But it differs from a VAD in that it sucks blood from a different chamber of the heart and returns it through a different artery. Because it is designed for patients in an earlier stage of heart failure, whose hearts can still pump a modest amount of blood on their own, the Synergy pump gets by on a smaller, less powerful motor. Unlike implantable VADs, which rest deep inside the chest cavity, the Synergy pump is small enough to be placed near the skin’s surface.

“It’s a very small, very well engineered device,” says Yoshifumi Naka, director of the Mechanical Circulatory Support Program at Columbia University Medical Center.

The device began clinical testing in Europe in June 2007 and has been implanted in nine patients so far. All nine have survived to date, and five have successfully gone on to heart transplants. CircuLite estimates that U.S. clinical trials will begin in early 2009.

The pump itself may sit just beneath the skin, but its inflow tube extends much deeper, into the left atrium of the heart. Currently, in the European studies, the surgeon goes between ribs to place the tube. This “mini-thoracotomy” is faster and safer than the full sternotomy required for most other implantable pumps, but heart-lung bypass is still required.

The Synergy Pocket Circulatory Assist device from Circulite, a company out of Saddle Brook, New Jersey and Aachen, Germany, is doing well in a European clinical trial, according to the MIT Tech Review.

According to the magazine, the device, first covered by us in Aug 2007, has been implanted in nine patients, all of them still alive and apparently doing well. Of these patients, five have successfully gone on to heart transplants, showing the device to be a potentially useful modality as a bridge to transplantation.

A quick refresher on the technology:

6578circ2 Synergy Pocket Circulatory Assist Device Does Well in Early Trial

… the Synergy Pocket Circulatory Assist device combines a superficially positioned micro-pump with inflow and outflow cannulae placed with endovascular techniques. Blood is drawn from the Left Atrium via the Inflow Cannula that is connected to the micro-pump which pumps the blood back to the body via the Outflow Graft to the Subclavian Artery…

The Synergy Pocket Circulatory Assist device works in synergy with the patient’s native heart function and pumps up to 3 liters of blood per minute (partial circulatory assist) to increase the total cardiac output (blood to body).

The hemodynamic effects of partial circulatory assist were assessed in a computer-based heart failure simulation model which predicts partial circulatory assist of 2 to 3 liter of blood flow per minute:

Decreases left ventricular end diastolic pressure by 7 to 10 mm Hg

Provides significant pressure and volume unloading of the native heart

Increases net cardiac output by ~ 1 liter of blood flow per minute

The hemodynamic effects of partial circulatory assist have also been reported in a small, single center study. Twenty patients supported on HeartMate™ VE Ventricular Assist Device (VAD), were assessed on full assist (approximately 5 liters of blood flow per minute) and partial assist (approximately 1.6 liters of blood flow per minute) which was achieved by reducing the device’s cycles per minutes setting. The authors concluded that partial circulatory assist:

Improved peak VO2 consumption

Improved myocardial function

…Synergy device micro-pump has been refined to be the smallest implantable blood pump and has several unique features that are designed to minimize the risk of thrombus formation and hemolysis.

The Synergy device micro-pump combines axial, centrifugal and orthogonal flow paths with a single-stage impeller that is powered by an integrated brushless micro-electric motor. The micro-pump is the size of a AA battery with an outer body diameter of 14 mm, length of 49 mm, weight of 25 grams and pumps up to 3 liters of blood per minute.

The Synergy device micro-pump design features a unique magnetically and hydrodynamically levitated and stabilized impeller design. The design allows the motor to be sealed thus eliminating blood contact in the motor and the potential of thrombosis formation. The micro-pump also features a proprietary self-washing flow path that minimizes the risk of thrombus formation in or around the impeller.

Source : http://www.technologyreview.in/news/410099/tiny-blood-pumps-for-failing-hearts/

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SYNERGY Mini Heart Assist Pump from CircuLite Now Cleared in Europe

SYNERGY Mini Heart Assist Pump from CircuLite Now Cleared in Europe

SYNERGY Mini Heart Assist Pump from CircuLite Now Cleared in Europe

SADDLE BROOK, N.J. and AACHEN, Germany (September 5, 2012) — CircuLite®, Inc. today announced that it has received CE Marking approval for the SYNERGY® Circulatory Support System, a micro-pump designed to halt the progression of heart failure. By working with the heart’s native pumping capacity, SYNERGY is specifically targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management.

SYNERGY is approximately the size of a AA battery and is implanted superficially in a pacemaker-like pocket under the right collarbone. SYNERGY is approximately 90 percent lighter than existing ventricular assist devices (VADs), and unlike VADs, implantation of SYNERGY is faster and does not require an open-chest procedure or cardiopulmonary bypass.

CE Marking approval was based on positive clinical results from 44 patients in an ongoing, multi-center European trial, recently presented at the International Society for Heart and Lung Transplantation (ISHLT) meeting. A total of 59 patients have been implanted with the SYNERGY System in the CE Mark trial at 9 European centers.

“There is currently a gap in the treatment of heart failure, with no satisfactory options available for patients who are not responding to standard medical therapy. SYNERGY, with its small size, minimally invasive procedure and relatively fast procedure time, is ideally suited for these patients,” said Bart Meyns, M.D., Ph.D., Professor and Chief of Cardiac Surgery at Gasthuisberg University Hospital and Principal Investigator of CircuLite’s clinical study. “In my experience with this technology, the results have been remarkable. Patients typically recover from the procedure quickly and are soon after able to perform many activities that they could not do before. This technology allows me to provide a new treatment strategy for a large number of patients who previously had no definitive options.”

“The European approval of SYNERGY is a significant milestone both for CircuLite and, more broadly, for the treatment of heart failure,” said Paul Southworth, President and Chief Executive Officer of CircuLite. “SYNERGY changes the paradigm of heart failure treatment for those who are not responding to standard medical management by working as a complement to the heart’s function. The benefits are multifaceted—patients feel better, recover rapidly and are discharged quickly—which provides the potential for a cost reduction impact for hospitals. With CE Marking in place, we will begin a controlled launch of this groundbreaking advancement in select European markets.”

About the SYNERGY® Circulatory Support System

The SYNERGY Circulatory Support System is a micro-blood pump that provides up to 4.25 liters of blood per minute and reduces the heart’s workload, while improving blood flow to vital organs. The system is surgically implanted using a mini-thoracotomy and is placed in a pacemaker-like pocket. In a clinical study, SYNERGY improved hemodynamics, exercise capacity and overall quality of life. SYNERGY is designed and manufactured in Aachen, Germany.

About CircuLite®

CircuLite is developing disruptive solutions to improve the treatment of heart failure. The Company’s technologies work in conjunction with the heart to enhance clinical outcomes and improve quality of life. SYNERGY®, which recently received CE Marking approval, features the smallest surgically implanted blood pump for long-term use in patients with heart failure not responding to standard medical treatment. For more information, visit our website at www.circulite.net.

CAUTION: Investigational Device. Limited by United States Law to Investigational Use Only.

CircuLite® and SYNERGY® are registered trademarks of CircuLite, Inc. in the United States.

SYNERGY is a miniature ventricular support system that offers the potential of a new minimally invasive treatment option for patients with chronic heart failure who are not responding to standard medical care. SYNERGY received CE Mark approval in Europe in September 2012.

The system’s less invasive implant procedure is intended to reduce the surgical risks associated with implant procedures that require cardiopulmonary bypass support. In addition, SYNERGY is intended to reduce symptoms of heart failure and associated re-hospitalizations, as well as to improve exercise tolerance and quality of life.

The SYNERGY system is comprised of CircuLite’s proprietary Micro-pump, inflow cannula and outflow graft, a percutaneous lead that is connected to a wearable external controller and a lightweight, rechargeable dual battery pack system. SYNERGY’s Micro-pump is the size of a AA battery, provides up to 4.25 liters of blood flow per minute, and is intended to reduce the heart’s workload while improving blood flow to vital organs. SYNERGY supplements the heart’s native pumping capacity and preserves its ability to respond to the patient’s cardiac output demands. The system is surgically implanted using a mini-thoracotomy and the Micro-pump is placed in a pacemaker-like pocket.

Patient Population

The SYNERGY system is designed for long-term use in patients diagnosed with NYHA Class IIIb/early Class IV (INTERMACS 4-6) heart failure, who typically:

Suffer from compromised quality of life,

Are symptomatic despite optimal medical therapy,

Are ambulatory, though often house-bound,

Have frequent hospitalizations for management of heart failure symptoms and

Retain some intrinsic cardiac output and reasonably normal end-organ function.

The Micro-pump

The Micro-pump combines axial, centrifugal and orthogonal flow paths with a single-stage impeller that is powered by an integrated brushless micro-electric motor. The Micro-pump design features a unique magnetically and hydrodynamically levitated and stabilized rotor design. The design allows the motor to be sealed, thus eliminating blood contact in the motor and minimizing the potential of thrombus formation. The Micro-pump also features a proprietary self-washing flow path and a proprietary alternating speed algorithm that is designed to minimize the risk of thrombus formation in or around the rotor. The Micro-pump is superficially placed in a pacemaker-like pocket with minimally-invasive techniques. CircuLite’s development of the Micro-pump is backed by eight years of engineering at the Helmholtz Institute in Aachen, Germany, one of the world’s leading centers for blood pump technology development, in collaboration with Katholieke Universiteit in Leuven, Belgium.

Synergy device shot

The Power System

A wearable, lightweight, rechargeable dual battery pack system and controller are used to control and power the SYNERGY system. The power system weighs approximately 1.0 kg / 2.2 pounds and the dual battery pack will power the system for approximately 6- 8 hours. The controller provides the patient with information on the battery status and alerts the patient to any change that needs attention. The Micro-pump is connected to the power system via a percutaneous lead that exits the body in the abdominal area. The power system is designed to allow un-tethered (not connected to an electrical outlet) patient mobility. An important feature of the SYNERGY system is its ability to work in conjunction with the patient’s remaining native heart function. In the event of accidental power disconnection, patients may be supported by their remaining cardiac output until power can be restored to the system.

Image of the controller and battery pack

The Procedure

SYNERGY’s innovative design and implantation procedures allow cardiothoracic surgeons to implant the device in as short as 90 minutes, potentially reducing risk and enabling faster patient recovery.

Clinical trials of SYNERGY have utilized a right mini-thoracotomy procedure which does not require cardiopulmonary bypass. With this approach, the inflow cannula is placed into the left atrium and the outflow graft is attached to the subclavian artery. The Micro-pump is then placed in a pacemaker-like pocket and connected to the inflow cannula and outflow graft.

Source : http://www.circulite.net/news-events/press-releases-2012-09-05.php

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Surefire Infusion System for Infusion Embolizations Gets CE Mark

Surefire Infusion System for Infusion Embolizations Gets CE Mark

Surefire Infusion System for Infusion Embolizations Gets CE Mark

Since launching in August 2011, Surefire Medical has been delivering innovative infusion systems for the interventional radiology market. Surefire’s infusion catheters—which precisely deliver embolic agents through a novel expandable tip that collapses in forward flow and dynamically expands to the vessel wall in reverse flow—are designed to increase infusion efficiency and minimize reflux.

“After using the Surefire Infusion System during infusion procedures, I can see how it can potentially improve on patient outcomes both with respect to safety profile and improved tumor control. As a leader in cancer treatment, we are always looking for cutting-edge technologies like the Surefire device. After carefully documenting our experience over the past six months, I believe that this technology is potentially game changing and is a powerful tool for interventional radiologists.”

— Steven Rose, M.D. at University of California at San Diego Medical Center

Surefire Medical has assembled a team of professionals with expertise in the medical, manufacturing and financial industries, as well as a wide range of managerial and entrepreneurial experience.

WESTMINSTER, Colo., USA (Sept. 5, 2012) – European regulators have approved Surefire

Medical’s Surefire Infusion System, a next generation device for chemo- and radioembolization

procedures. The Colorado-based medical device company today announced that it is launching

this product in the European market immediately.

“Surefire Medical developed this ground-breaking technology to provide interventional

radiologists with improved embolization certainty during their infusion procedures,” said Jim

Chomas, CEO of Surefire Medical. “With the CE Mark approval, we are able to introduce the

Surefire Infusion System, which may offer substantial advantages over a standard

microcatheter, throughout Europe.”

Clinical

Surefire Medical, Inc., based in Westminster, Colo., was founded in 2009 to develop innovative

infusion systems for the interventional radiology and interventional oncology markets.

Surefire’s infusion systems are designed to precisely deliver embolic agents through a unique

microcatheter with an expandable tip that collapses in forward flow and dynamically expands

to the vessel wall in reverse flow in order to increase embolization efficiency, minimize reflux

and reduce damage to healthy tissue. For more information, please visit

www.surefiremedical.com.

Surefire Medical out of Westminster, CO received European clearance to market its eponymous Surefire Infusion System for use in for chemo- and radioembolization procedures. The system is designed to offer a more consistent embolization option over traditional microcatheters.

According to the company, a clinical study of the Surefire demonstrated no visible (under angiography) reflux nor any evidence of embolization of tissue not explicitly targeted by the physician. The system has been approved in the U.S. since the Summer of last year.

From the product page:

Surefire’s infusion catheters—which precisely deliver embolic agents through a novel expandable tip that collapses in forward flow and dynamically expands to the vessel wall in reverse flow—are designed to increase infusion efficiency and minimize reflux.

Source : http://surefiremedical.com/about-us

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Cepheid Receives CE Approval for New STD Assays on Their GeneXpert System

Cepheid Receives CE Approval for New STD Assays on Their GeneXpert System

Cepheid Receives CE Approval for New STD Assays on Their GeneXpert System

Improving patient outcomes is always the goal of molecular diagnostics. Our GeneXpert® family of systems has set a new standard in workflow flexibility, 24/7 testing accuracy, and user-friendly design-delivered in an astonishingly compact package.

But we’ve done more than just repackage a good thing-we’ve improved on the fit, form, and function of the most popular molecular diagnostic platform on the market.

GeneXpert System technology is the cornerstone of our unique approach to molecular diagnostics product suite, which allows us to offer a complete menu of tests on a single, fully scalable, consolidated workstation.

The GeneXpert System is available in a one, two, four, or 16-module configuration. All have our proven GeneXpert module at their analytic heart, and use the same patented cartridge technology for every

Xpert® test.

Diagnostics on hyper-drive.

When it comes to speed, other molecular analyzers simply can’t compete. The GeneXpert System returns most test results in about an hour, including sample prep! Our systems deliver results even faster than many alternative technologies, such as EIA or Immunoassay.

With the GeneXpert technology, labs no longer need rows of equipment and extensively trained staff to access molecular testing. No matter which GeneXpert System you choose, Cepheid’s technology makes on-demand molecular testing available to everyone-with unprecedented speed and ease-of-use.

Our patented cartridges also deliver unsurpassed accuracy across the broadest possible menu, and are virtually unlimited in the sample types they can process.

Compact size, giant ability.

With its compact design, the GeneXpert System allows for portability in the field and can run tests just about anywhere. In fact, due to the recent World Health Organization (WHO) endorsement of our systems, we now have molecular diagnostic “centers of excellence” in some of the most remote places on earth.

The decreased system footprint and consolidated testing design creates space-saving efficiency, reducing the need for multiple testing platforms. These new systems are also designed to be stackable, for those labs where space is a particular issue.

And we’ve now introduced a new configuration, the two-module GeneXpert System, to provide even more options for smaller institutions.

More horsepower under the hood.

Underneath the clean lines of the system exterior, components have been reconfigured to further reduce the system footprint.

These revised components, including larger fans, also helps these new systems to run cooler and quieter—which means the most reliable molecular systems on the market just got even more so.

But the heartbeat of our technology—the patented cartridge and module—remains unchanged. You can count on all current and future tests running on any generation of GeneXpert System.

Tuberculosis is still a huge global health problem, with the most frightening part perhaps being the multi-drug resistant strains of the mycobacterium. One obstacle which has hampered effective control of this disease, especially in poor countries, is the long time it takes to diagnose it. In these lower-income areas, the standard diagnosis of TB is by microscopy, but this does not give any information on drug-resistance – those cell culture tests take two weeks, by which time it might have spread to many other people.

A Swiss group, The Foundation for Innovative New Diagnostics, has come up with a better way. The sputum sample is first treated with sodium hydroxide and alcohol, killing any TB, and the sample is fed into a small device which analyzes the DNA and gives a simple report regarding the presence of TB and the resistance status of the organism. This shrinks the time-frame for diagnosis of multi-drug resistant TB from 2 weeks to 2 hours. The individual tests cost only $17, although the machine costs $17,000. This is a nice example of cutting-edge technology being scaled to low-cost applications in resource-poor areas.

Cepheid, Sunnyvale, CA, received CE approval for a new infectious diseases assay on their GeneXpert system. The new assay enables rapid detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The GeneXpert works with disposable, single-use cartridges that hold the sample and reagent in a small processing chamber. Many assays are already available like the MRSA, enteroviruses and Group B Streptococcus cartridges.

GeneXpert cartridge Cepheid Receives CE Approval for New STD Assays on Their GeneXpert SystemThe GeneXpert itself is a closed, self-contained and automated platform. It combines on-board sample preparation with real-time PCR amplification and detection functions for nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences and comes in a one, two, four, or 16-module configuration.

John Bishop, Cepheid’s Chief Executive Officer is cited in the press release:

“We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG a test designed from the ground up to provide unprecedented accuracy, ease of use, and results availability. We expect these innovative products to deliver new levels of confidence to clinicians making same-day decisions in consulting with, and treating, their patients the critical first step in effectively managing these diseases.”

Source : http://www.cepheid.com/systems-and-software/genexpert-system

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Hansen Medical’s Magellan Robotic System for Vascular Interventions Gets FDA Nod

Hansen Medical’s Magellan Robotic System for Vascular Interventions Gets FDA Nod

Hansen Medical’s Magellan Robotic System for Vascular Interventions Gets FDA Nod

Hansen Medical announced the world’s first use of the Magellan Robotic System in Peripheral Vascular Disease endovascular care. The device, covered before here at Medgadget, uses robotics to allow for more precise catheter delivery and guidewire manipulation in the endovascular treatment of peripheral vascular disease.

The ability to have accurate independent distal tip control of the sheath, catheter, and robotic manipulation of guidewires from a workstation will potentially allow for reduced procedure time, radiation exposure, and possible improved quality of treatment. This milestone first clinical case was performed at St. Mary’s Hospital in London (part of the Imperial College Healthcare).

MOUNTAIN VIEW, CA, Jun 04, 2012 (MARKETWIRE via COMTEX) — Hansen Medical, Inc. HNSN -0.68% , a global leader in intravascular robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Magellan(TM) Robotic System, including the catheter and accessories. The Company will commence commercialization at selected centers in the U.S. immediately, with a full launch expected later in the year. The product will be presented at the 66th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, Maryland from June 7-9.

The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The System has the potential to provide vascular surgeons and other interventionalists the ability to perform fast and predictable procedures, while allowing the physician to be seated comfortably away from the radiation source, which may reduce radiation exposure and physician fatigue.

“Today’s announcement marks one of the most significant milestones in the Company’s history,” said Hansen Medical President and CEO Bruce Barclay. “Not only does the Magellan System have the potential to be a significant growth driver for Hansen, it also represents a fundamental step forward in the transformation of vascular intervention using intravascular robotics.”

The global vascular market is large and expanding rapidly, driven by an aging population, the prevalence of diabetes and obesity, and an increase in disease awareness. Of the more than 3 million vascular procedures done worldwide each year, approximately one-third to one-half of them could be addressed using the Magellan Robotic System.

Dr. Alan Lumsden, Chair of Hansen Medical’s U.S. Scientific Advisory Board, and Chair of the Department of Cardiovascular Surgery and Medical Director of Methodist DeBakey Heart and Vascular Center at The Methodist Hospital, Houston, commented, “The Magellan Robotic System is a significant technological advancement that may offer important clinical benefits for physicians performing peripheral interventions. The System provides physicians with independent robotic control of both catheter tips to navigate efficiently through a variety of anatomies and lesions. Our in vitro and in vivo animal studies indicate that using this platform has the potential to increase efficiencies in the interventional lab by shortening procedure times and allowing more predictable interventions. Ultimately, we believe this System may facilitate alternative patient treatment options by enabling robotic endovascular interventions.”

The Magellan Robotic System results in a new standard for peripheral vascular intervention that has the potential to deliver revolutionary lesion access, precise distal tip control, solid catheter stability and consistent procedural efficiency.

Dr. Jean Bismuth, a leading vascular surgeon at the DeBakey Heart and Vascular Center at The Methodist Hospital, Houston, said, “Since the Magellan Robotic System was designed specifically for vascular interventions, it offers excellent catheter stability and precision during the delivery and placement of a variety of therapeutic devices in different anatomic conditions, including various peripheral vascular diseases with tortuous anatomy. Additionally, the Magellan Robotic System may offer physicians less radiation exposure and reduced procedural fatigue due to the remote workstation that allows the physician to be seated comfortably outside the imaging suite.”

The Company believes the Magellan platform also provides a compelling value proposition to hospitals.

“Hospitals today need to ensure not only quality patient care, but also sound fiduciary judgment in all purchase decisions,” continued Barclay. “To remain competitive in the markets they serve, hospitals need to become more efficient, while also increasing their patient capacity. The Magellan Robotic System has the potential to help hospitals accomplish both of these goals.”

“We are excited about the initial interest a number of key U.S. hospitals have shown in the Magellan System and intend to focus our near-term commercialization strategy on partnering with a select group of esteemed physicians who are both influential and early adopters of new technologies in the industry,” said Barclay. “We will provide them with the appropriate training and engage with them to demonstrate the benefit and value of the Magellan. This focused and controlled commercial launch should enable us to generate positive clinical experiences and data to drive both interest and adoption among other physicians and hospitals in the large and rapidly expanding U.S. peripheral vascular market, and will be followed later this year with full launch activities.”

Barclay concluded, “Today’s announcement is a testament to the immensely talented development and support teams at Hansen Medical that worked tirelessly to reach this important milestone, and I want to personally congratulate and thank them for their hard work.”

The Magellan System received a CE Mark in the European Union last year, and the Company has already commenced a commercial launch in that region. In addition, the System has been approved in Australia, and is pending approval in Canada.

About the Magellan(TM) Robotic System Hansen Medical’s Magellan Robotic System is based upon the flexible robotic technology incorporated in the Sensei-X(R) Robotic Catheter System currently sold in the U.S. and Europe, which has been used in more than 8,000 patients, but includes a number of key enhancements. In particular, the Magellan Robotic System:

– Provides solid catheter stability for placement of therapeutic

devices.

– Is designed to enable predictable procedure times and increased case

throughput.

– Allows for independent, individual robotic control of the distal tips

of both the outer sheath and the inner leader catheter, as well as

robotic manipulation of standard guidewires.

– Is designed to allow for sufficient extension inside the body to

access hard to reach peripheral anatomy.

– Preserves the open architecture featured in the Sensei System to allow

for the subsequent use of many 6F therapeutic devices on the market

today.

– Is designed to potentially reduce physician radiation exposure and

fatigue by employing a remote physician workstation.

Hansen Medical Conference Call Company management will hold a conference call to discuss the receipt of 510(k) clearance for the Magellan Robotic System today, June 4, 2012, at 2:00 p.m. Pacific (5:00 p.m. Eastern). Investors are invited to listen to the call live via the Internet using the link available within the “Investor Relations” section of Hansen Medical’s website at http://www.hansenmedical.com/ . Additionally, participants can dial into the live conference call by calling 877-941-1427 or 480-629-9664. An audio replay of the webcast will be available approximately one hour after the completion of the conference call through June 11, 2012, by calling 877-870-5176 or 858-384-5517, and entering access code 4544736.

About Hansen Medical, Inc. Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company’s Sensei(R) X Robotic Catheter System and Artisan Control Catheter were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the United States, the Sensei System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei X System and Artisan Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established. In the European Union, the Sensei X System and Artisan Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx(R) Robotic Ablation Catheter is cleared for the treatment of AF. The Company’s Magellan(TM) Robotic System, NorthStar(TM) Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S.

Additional information can be found at www.hansenmedical.com .

Forward-Looking Statements This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” goal,” “estimate,” and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about the potential benefits of our Magellan Robotic System on the vascular procedures and the timing and results of commercializing our Magellan Robotic System. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses and obtain additional financing; and other risks more fully described in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 filed with the SEC on May 7, 2012 and the risks discussed in our other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), and Sensei are registered trademarks, and Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.

The FDA has given Hansen Medical (Mountain View, CA) the green light to bring the Magellan Robotic System domestically for peripheral vascular interventional procedures. It received European approval about a year ago and is already being used by clinicians.

The Magellan allows surgeons to remote control the distal tip of a catheter and a sheath from a workstation, offering potentially greater precision to surgeons and better outcomes with shorter procedure times for patients.

From the announcement:

The Company will commence commercialization at selected centers in the U.S. immediately, with a full launch expected later in the year. The product will be presented at the 66th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, Maryland from June 7-9.

The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The System has the potential to provide vascular surgeons and other interventionalists the ability to perform fast and predictable procedures, while allowing the physician to be seated comfortably away from the radiation source, which may reduce radiation exposure and physician fatigue.

Source : http://www.marketwatch.com/story/

www.hansen-medical-receives-fda-510k-clearance-for-its-magellantm-robotic-system-for-peripheral-vascular-interventions-2012-06-04

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The Augmented Reality Diet

The Augmented Reality Diet

The Augmented Reality Diet

They say that some people look at a glass as half-empty and others see it as half-full. Well, if there is calorie-laden soda in the glass, chances are it’d be better for someone to view it as empty and save themselves the sugar overload. Thanks to Japanese researchers and some augmented reality ingenuity, it may be possible in the not-too-distant future to change someone’s perception of how much and what type of food they’re eating.

The “diet devices” and results of using them are described in an article published in The Province, a Canadian paper:

On one device goggle-mounted cameras send images to a computer, which magnifies the apparent size of the cookie in the image it displays to the wearer while keeping his hand the same size, making the snack appear larger than it actually is.

In experiments, volunteers consumed nearly 10 per cent less when the biscuits they were eating appeared 50 per cent bigger.

They ate 15 per cent more when cookies were manipulated to look two-thirds of their real size.

In another project, Hirose’s team developed a “meta cookie”, where the headgear uses scent bottles and visual trickery to fool the wearer into thinking the snack they are eating is anything but a plain biscuit.

Users can set the device to their favourite taste so they think they are eating a chocolate or strawberry-flavoured cookie.

Hirose says experiments so far have shown 80 per cent of subjects are fooled.

A brief look at the lab’s website gives provides additional insight into their augmented reality projects, which range from a lifelog to a wearable olfactory display. Though there are no plans at present to commercialize these devices, we hope that they, or similar ideas, come to fruition so that dieters can have their cake, but not necessarily eat it too.

Source : http://www.theprovince.com/health/Japan+diet+glasses+fool+wearers+into+eating+less/6726097/story.html

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TrueDX Receives CE Approval for TSH testing On a New Point-of-Care system

TrueDX Receives CE Approval for TSH testing On a New Point-of-Care system

TrueDX Receives CE Approval for TSH testing On a New Point-of-Care system

SAN DIEGO, CA – May 24, 2012 – True Diagnostics, Inc.™ (www.TrueDiagnostics.com) has announced it has received a CE Mark to allow it to distribute its TrueDX Platform and quantitative TSH (Thyroid Stimulating Hormone) test in Europe. With the TrueDX Platform, doctors can immediately determine if a patient suffers from a hypoactive thyroid by using only a finger prick of blood. This unique test enables doctors and patients to gain access to diagnosis in minutes, create an effective treatment plan, while saving physicians’ time and patients cost and anxiety. True Diagnostics is actively engaging distribution partners throughout all EU markets, with initial focus in Germany, UK, France, Italy and Spain.

This is the second regulatory clearance for the TrueDX Platform with TSH test, having received sFDA approval for China in September 2011. True Diagnostics expects to run short clinical studies in the U.S. this summer and further submit for CLIA-waive and 510k FDA clearance to market the TrueDX Platform with quantitative TrueDX-TSH™ Tests throughout the U.S.

What will the TrueDX Platform mean for doctors and patients seeking to more easily identify Hypoactive Thyroid? Hypothyroidism affects over 200 million people globally, more than people with diabetes. TSH is the fourth most requested blood test in America. Hypothyroidism is commonly undiagnosed and misdiagnosed with symptoms ranging from weight gain to depression, forgetfulness, hair loss, thinning and drying of skin, fatigue, loss of libido, feeling cold, constipation, and a pronounced goiter.

Jerry Lee, President/CEO of True Diagnostics, notes, “With this latest regulatory clearance, the Company has laid the foundation to begin standardizing a full range of diagnostic and monitoring tests that will provide instant results to doctors and patients and demand little training. With distribution partners already lined up and more coming soon, we expect initial shipments to Europe to begin within 60 days.”

The strength of the TrueDX Platform lies in its simplicity. Tests have a 24-month shelf life. They do not need to be refrigerated. Laboratory quality results from small samples can now be available to doctors to review in minutes. The TrueDX Platform’s simplicity, portability, and affordability allow it to be easily adopted into emerging markets. The platform’s flexible design also permits it to stay ahead of potential competitors and quickly commercialize a myriad of new biomarkers discoveries for cancer, autism, alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections, and more. In essence, any biomarker discovery utilizing traditional lab methods, such as an ELISA process, can now be developed into a simple, fast, and portable assay which can offer quick diagnosis and treatment right in the physician’s office.

About the Company True Diagnostics, Inc. creates simple diagnostic solutions for the $46 billion medical point-of-care, sterility assurance, animal health, and food processing markets. After 30 years in the global medical diagnostic field, the inventor of the home pregnancy test created the TrueDX Platform which can measure the severity of any medical condition (using only a finger prick of blood, small urine or saliva sample, toxins, surface bacteria, and more), provide results in minutes (not days), and is completely portable. The TrueDX Platform takes point-of-care, point-of-incidence, and remote-of-care applications out of the lab to provide more flexible treatment that can begin immediately. The TrueDX Platform creates unique and powerful opportunities for new diagnostic solutions through its ability to: 1) quickly bring new diagnostic tests to market; and, 2) open new geographic and application opportunities.

For more information, call 760-683-9158 or go to www.TrueDiagnostics.com

True Diagnostics introduces the TrueDX Platform for use with an ever-growing list of tests for medical and environmental conditions. The TrueDX Platform is comprised of six elements: 1) The TrueDX™ Reader; 2) TrueDX™ Tests; 3) Raw scanned data; 4) TrueDX™ Software for analyzing scans; 5) Graphical user interface; and, 6) Network connectivity through computer linkage.

To learn more about the TrueDX Platform contact us.

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TrueDX™ Reader

True Diagnostics introduces the TrueDX Reader, both easy-to-use and portable, and designed to read all TrueDX™ Tests. The Reader requires a USB-port for power and only a few minutes to load and set-up its proprietary analysis software. Initial screening and monitoring of conditions are faster, easier and more portable than ever. The TrueDX Reader is designed for use with the TrueDX™ Platform.

To learn more about the TrueDX Reader contact us.

truedx_reader.jpg

TrueDX™ Software

True Diagnostics introduces the TrueDX Software, both easy-to-use and portable, and designed to read all TrueDX™ Tests. The Software only takes a few minutes to load and set-up its proprietary analysis software. Initial screening and monitoring of conditions are faster, easier and more portable than ever. The TrueDX Reader is designed for use with the TrueDX™ Platform.

To learn more about the TrueDX Software contact us.

truedxtsh.jpg

TrueDX-TSH™ Test

True Diagnostics introduces the TrueDX-TSH Test using simple and quantitative immunoassay technology for both initial detection and monitoring of TSH in whole blood. Using only finger stick whole blood, health professionals can now make timely medical decisions in the most remote locations around the world. The TrueDX-TSH Test is designed for use with the TrueDX Platform.

For For Export Only

To learn more about the TrueDX-TSH Test contact us.

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TrueDX-T4™ Test

True Diagnostics has also created a TrueDX-T4 Test for the detection and monitoring of free thyroxin in whole blood. With only a finger stick of whole blood, a simple and quantitative test is now available for global health professional. The TrueDX-T4 Test is designed for use with the TrueDX Platform.

For Research Use Only

To learn more about the TrueDX-T4 Test contact us.

truedxgramnegative.jpg

TrueDX-GNeg™ Test

True Diagnostics introduces the TrueDX-Gram Neg Test, the first simple & quantitative immunoassay test for the detection and monitoring of Gram-Negative Microorganisms from multiple surfaces using a small sample size. The TrueDX-GNeg Test is designed for use with the TrueDX Platform.

For Research Use Only

To learn more about the TrueDX-GNeg Test contact us.

truedxgrampositive.jpg

TrueDX-GPos™ Test

True Diagnostics introduces the TrueDX-GPos Test, the first simple & quantitative immunoassay test for the detection and monitoring of Gram-Positive Microorganisms from multiple surfaces using a small sample size. The TrueDX-GPos Test is designed for use with the TrueDX Platform.

For Research Use Only

To learn more about the TrueDX-GPos Test contact us.

truedxpsa.jpg

TrueDX-PSA™ Test

True Diagnostics introduces the TrueDX-PSA Test, the first simple & quantitative immunoassay test for initial detection and monitoring of PSA in whole blood. Using only finger stick whole blood, health professionals can now make timely medical decisions in the most remote locations around the world. The TrueDX-PSA Test is designed for use with the TrueDX Platform.

True Diagnostics, Carlsbad, CA, received CE approval for a quantitative TSH (Thyroid Stimulating Hormone) test on the TrueDx platform. This new platform is a completely portable point of care system that can handle multiple tests on a single reader. A finger pin prick of blood, small urine or saliva sample can be analyzed at point-of-care, and a digital signal even allows to extend functionality to Remote-of-Care wireless applications.

The Reader only requires a USB-port for power and a few minutes to load and set-up its proprietary analysis software. The test itself is a quantitative immunoassay offering detection and monitoring of markers in whole blood and it can be stored for 2 years at room temperature.

TrueDX Reader TrueDX Receives CE Approval for TSH testing On a New Point of Care systemThe company claims to have 61 tests in its product pipeline of which 57 have passed through proof of concept. The detection of hypothyroidism by quantitative measurement of TSH in blood is their first approved clinical test available in Europe. Other tests are available for research only, which include: quantitative T4, gram negative bacteria (Gneg), gram positive bacteria (Gpos) and prostate specific antigen (PSA).

Jerry Lee, President/CEO of True Diagnostics is cited in the press release:

“With this latest regulatory clearance, the Company has laid the foundation to begin standardizing a full range of diagnostic and monitoring tests that will provide instant results to doctors and patients and demand little training. With distribution partners already lined up and more coming soon, we expect initial shipments to Europe to begin within 60 days.”

True Diagnostics expects to run short clinical studies in the U.S. this summer and further submit for FDA clearance to market the TrueDX Platform throughout the U.S.

Source : http://www.truediag.com/press52412.html

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The Promise of TMS: Interview with Neuronetics Chief Medical Officer Mark Demitrack

The Promise of TMS: Interview with Neuronetics Chief Medical Officer Mark Demitrack

The Promise of TMS: Interview with Neuronetics Chief Medical Officer Mark Demitrack

The NeuroStar TMS Therapy System is the first and only TMS device cleared by the U.S. Food and Drug Administration (FDA) to treat patients with Major Depressive Disorder (MDD) who have not benefited from initial antidepressant treatment.* This breakthrough depression treatment uses a highly focused, pulsed magnetic field, similar in type and strength to those produced by a magnetic resonance imaging (MRI) machine, to stimulate function in brain regions known to affect mood. The NeuroStar TMS Therapy System utilizes several unique patented technologies to maximize patient treatments:

SenStar® Treatment Link – The link to safe, effective and tolerable treatment

MT Assist® – Unique software makes finding the right treatment dose easy

Precision Pulse TMS™ Technology – Patented coil design improves efficiency which increases patient throughput

Coil Positioning System – Integrated positioning system assures repeatable and accurate treatment.

TMS TrakStar™ – Proprietary patient database that facilitates TMS reporting and documentation

The NeuroStar® System was designed for therapeutic use. To guide our customers in establishing and operating a successful TMS clinic, Neuronetics provides all key system components and software as well as clinical training and services as part of the cost of the NeuroStar TMS Therapy System.

View the NeuroStar TMS Therapy System components

*NeuroStar TMS Therapy® is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. Click here for full prescribing and safety information.

Transcranial magnetic stimulation (TMS) has been studied as a potential therapy for disorders ranging from drug addiction to bipolar disease. The premise is that pulsed, MRI-grade magnetic fields can locally excite or inhibit regions of the cerebral cortex, thus affecting neurological function. The makers of the NeuroStar TMS System, Neuronetics, contacted us to let us know about their new study released at the American Psychiatric Association meeting in May. In brief, they treated patients who have unipolar, non-psychotic Major Depressive Disorder (MDD) with TMS and found that:

Overall, 58 percent of patients achieved a positive response to NeuroStar TMS therapy, with 37 percent of patients achieving remission from their depression.

After an average of five weeks of NeuroStar treatment, the percentage of patients reporting extreme problems with anxiety and depression decreased by 42.2 percent, demonstrating a reduction in depression symptomatology. For overall treatment effect, the percentage of patients reporting no problems in performing usual activities improved by 30.5 percent.

Medgadget had the opportunity to interview Neuronetics’ Chief Medical Officer to discuss the study and the NeuroStar TMS Therapy system.

Shiv Gaglani, Medgadget: What is unique about this study as compared to other studies that show TMS’ effects on depression?

Mark A. Demitrack M.D. The Promise of TMS: Interview with Neuronetics Chief Medical Officer Mark Demitrack, M.D.Mark A. Demitrack, M.D.: This study expands on prior work by showing that TMS has effects not just on the symptoms of depression (eg, sadness, anxiety, sleep, libido, appetite, et cetera), but also is able to demonstrate improvements in the ability for a person to resume normal life activities and experience an improved ability to function in day to day activities. In other words, the improvement in mood translates into improvements in real life activities.

Medgadget: How does TMS improve affect among depressed patients? What brain region(s) does it excite/inhibit?

Dr. Demitrack: We believe TMS exerts its effects by improving the metabolic activity (ie, the energy production) in the specific areas of the brain that we know are involved in the regulation of mood. The direct target of action is the left dorsolateral prefrontal cortex (the region right under the left front part of the head). The effects that are exerted there are also exerted indirectly on other areas of the brain that are connected to the DLPFC, including the anterior cingulate cortex, the amygdala and the hippocampus, among others.

Medgadget: What is the strength & penetration depth of the magnetic pulses?

Dr. Demitrack: The magnetic field produced by the NeuroStar TMS system is about 1.5 Tesla, or about the strength of a standard MR imaging device. The magnetic fields reach to a depth of about 3 – 4 cm into the brain directly.

Medgadget: Were any side effects observed?

Dr. Demitrack: The most common side effect directly related to the device is scalp pain or discomfort at the site of stimulation. Most patients find this to be mild to moderate in intensity, and it usually becomes unnoticeable after the first week.

Medgadget: What are NeuroStar’s next steps (e.g. FDA approval, studying TMS in other psychiatric populations)?

Dr. Demitrack: We continue to explore other areas of potential use of TMS in a variety of brain diseases.

Here’s a promo video for the company’s TMS therapy system:

http://www.youtube.com/watch?v=ZZRaTx1Q0U0&feature=player_embedded

Source : http://www.neuronetics.com/products-services/system/

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Paralyzed Rats Get Some Pep in Their Step After Two-Part Treatment Helps Them Walk Again

Paralyzed Rats Get Some Pep in Their Step After Two-Part Treatment Helps Them Walk Again

Paralyzed Rats Get Some Pep in Their Step After Two-Part Treatment Helps Them Walk Again

Rats with spinal cord injuries and severe paralysis are now walking (and running) thanks to researchers at EPFL. Published in the June 1, 2012 issue of Science, the results show that a severed section of the spinal cord can make a comeback when its own innate intelligence and regenerative capacity is awakened. The study, begun five years ago at the University of Zurich, points to a profound change in our understanding of the central nervous system. According to lead author Grégoire Courtine, it is yet unclear if similar rehabilitation techniques could work for humans, but the observed nerve growth hints at new methods for treating paralysis.

“After a couple of weeks of neurorehabilitation with a combination of a robotic harness and electrical-chemical stimulation, our rats are not only voluntarily initiating a walking gait, but they are soon sprinting, climbing up stairs and avoiding obstacles when stimulated,” explains Courtine, who holds the International Paraplegic Foundation (IRP) Chair in Spinal Cord Repair at EPFL.

Waking up the spinal cord

It is well known that the brain and spinal cord can adapt and recover from moderate injury, a quality known as neuroplasticity. But until now the spinal cord expressed so little plasticity after severe injury that recovery was impossible. Courtine’s research proves that, under certain conditions, plasticity and recovery can take place in these severe cases—but only if the dormant spinal column is first woken up.

To do this, Courtine and his team injected a chemical solution of monoamine agonists into the rats. These chemicals trigger cell responses by binding to specific dopamine, adrenaline, and serotonin receptors located on the spinal neurons. This cocktail replaces neurotransmitters released by brainstem pathways in healthy subjects and acts to excite neurons and ready them to coordinate lower body movement when the time is right.

Five to 10 minutes after the injection, the scientists electrically stimulated the spinal cord with electrodes implanted in the outermost layer of the spinal canal, called the epidural space. “This localized epidural stimulation sends continuous electrical signals through nerve fibers to the chemically excited neurons that control leg movement. All that is left was to initiate that movement,” explains Rubia van den Brand, contributing author to the study.

The innate intelligence of the spinal column

In 2009, Courtine already reported on restoring movement, albeit involuntary. He discovered that a stimulated rat spinal column—physically isolated from the brain from the lesion down—developed in a surprising way: It started taking over the task of modulating leg movement, allowing previously paralyzed animals to walk over treadmills. These experiments revealed that the movement of the treadmill created sensory feedback that initiated walking—the innate intelligence of the spinal column took over, and walking essentially occurred without any input from the rat’s actual brain. This surprised the researchers and led them to believe that only a very weak signal from the brain was needed for the animals to initiate movement of their own volition.

To test this theory, Courtine replaced the treadmill with a device that vertically supported the subjects, a mechanical harness did not facilitate forward movement and only came into play when they lost balance, giving them the impression of having a healthy and working spinal column. This encouraged the rats to will themselves toward a chocolate reward on the other end of the platform. “What they deemed willpower-based training translated into a fourfold increase in nerve fibers throughout the brain and spine—a regrowth that proves the tremendous potential for neuroplasticity even after severe central nervous system injury,” says Janine Heutschi, co-author in the study.

First human rehabilitation on the horizon

Courtine calls this regrowth “new ontogeny,” a sort of duplication of an infant’s growth phase. The researchers found that the newly formed fibers bypassed the original spinal lesion and allowed signals from the brain to reach the electrochemically-awakened spine. And the signal was sufficiently strong to initiate movement over ground—without the treadmill—meaning the rats began to walk voluntarily towards the reward, entirely supporting their own weight with their hind legs.

“This is the world-cup of neurorehabilitation,” exclaims Courtine. “Our rats have become athletes when just weeks before they were completely paralyzed. I am talking about 100% recuperation of voluntary movement.”

In principle, the radical reaction of the rat spinal cord to treatment offers reason to believe that people with spinal cord injury will soon have some options on the horizon. Courtine is optimistic that human, phase-two trials will begin in a year or two at Balgrist University Hospital Spinal Cord Injury Centre in Zurich, Switzerland. Meanwhile, researchers at EPFL are coordinating a nine million Euro project called NeuWalk that aims at designing a fully operative spinal neuroprosthetic system, much like the one used here with rats, for implanting into humans.

Citation:“Restoring voluntary control of locomotion after paralyzing spinal cord injury” Science, June 1st 2012

Authors: Rubia van den Brand, Janine Heutschi, Quentin Barraud, Jack DiGiovanna, Kay Bartholdi, Michèle Huerlimann, Lucia Friedli, Isabel Vollenweider, Eduardo Martin Moraud, Simone Duis, Nadia Dominici, Silvestro Micera, Pavel Musienko, and Grégoire Courtine.

Half of human spinal cord injuries lead to chronic paralysis. Here, we introduce an electrochemical neuroprosthesis and a robotic postural interface designed to encourage supraspinally mediated movements in rats with paralyzing lesions. Despite the interruption of direct supraspinal pathways, the cortex regained the capacity to transform contextual information into task-specific commands to execute refined locomotion. This recovery relied on the extensive remodeling of cortical projections, including the formation of brainstem and intraspinal relays that restored qualitative control over electrochemically enabled lumbosacral circuitries. Automated treadmill-restricted training, which did not engage cortical neurons, failed to promote translesional plasticity and recovery. By encouraging active participation under functional states, our training paradigm triggered a cortex-dependent recovery that may improve function after similar injuries in humans.

Source : http://actu.epfl.ch/news/walking-again-after-spinal-cord-injury/

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