Archive for ‘Developmental stage’

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Flexible Patch with Stainless Steel Microneedles for Safe and Painless Delivery of Drugs

Flexible Patch with Stainless Steel Microneedles for Safe and Painless Delivery of Drugs

patch-patch

 

Scientists at the KTH Royal Institute of Technology in Stockholm, Sweden have developed a new flexible microneedle patch that resolves some of the limitations of similar existing devices. Typically, drug delivery patches designed to penetrate only the top layers of skin, as opposed to transdermal devices, are made of a single material. While it’s best to have the base rather soft to achieve optimal contact and comfort, the needles have to be rigid in order to successfully pierce the skin.

flexible-patchThe KTH  team developed a composite device that consists of a soft base made from a polymer and rigid stainless needles that penetrate the skin. “To the best of our knowledge, flexible and stretchable patches with arrays of sharp and stiff microneedles have not been demonstrated to date,” said Frank Niklaus, a professor of micro and nanofabrication at KTH, in a statement.

The team built two versions of their patch, one more flexible than the other. The more stretchable device showed excellent pliability and each of its 50 needles successfully penetrated the skin in a 30 minute test.

If the technology proves itself in additional studies, it may help make microneedle patches considerably more common and applicable to a variety of patients and conditions.

Study in PLOS ONEFlexible and Stretchable Microneedle Patches with Integrated Rigid Stainless Steel Microneedles for Transdermal Biointerfacing…

Via: KTH Royal Institute of Technology…

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Studying One Molecule at a Time

Studying One Molecule at a Time

Studying One Molecule at a Time

Researchers Create Molecule-Sized Test Tubes

In a Howard Hughes Medical Institute laboratory in Illinois, a new kind of “test tube,” one-thousandth the diameter of a human hair and small enough to hold only a few molecules of DNA, is revolutionizing the way researchers observe the behavior of single molecules of DNA, RNA, or proteins. The test tubes are actually bubble-like nanocontainers that are porous to small molecules. Researchers can easily feed needed ions and other chemicals into the ultra-tiny reaction chambers.

Many scientists say that more can be learned about the dynamics of chemical reactions that power biological processes by studying the behavior of individual molecules rather than observing the collective behavior of many molecules, as scientists do now. But techniques for single-molecule studies are limited and often highly specialized. The new nanocontainers, however, will make single-molecule techniques both more accessible and more powerful, said Taekjip Ha, a Howard Hughes Medical Institute investigator at the University of Illinois at Urbana-Champaign. Ha and his Illinois colleagues are the creative force behind the new technology.

“I think this technique will go a long way toward my goal of commoditization of in singulo techniques, getting them out of specialists’ labs to the general research community.”

Taekjip Ha

“This technique enables study at the single-molecule level of any complex interactions between DNA, RNA and proteins that can be modulated by small molecules,” Ha explained. “These include how cancer drugs interfere with reactions central to the growth of tumors, and the mechanism by which motor proteins enable movement of molecules within the cell. It may even be possible to use this approach for ultrasensitive high-throughput screening of candidate drugs that can inhibit specific interactions between proteins.”

The researchers say their technique can be easily applied in other laboratories, to enable scientists to study individual molecular reactions free of the complications of analyzing reactions in bulk solution. The new approach also improves on other methods used for observing the behavior of single molecules. One of the most common methods required that single molecules be tethered to a surface. With nanocontainers, however, the vesicles themselves are attached to a surface, meaning the molecules inside do not have to be. This simplifies analysis, because the effects of the surface on the reaction do not have to be taken into account, the researchers said.

The researchers published their advance during the week of May 21, 2007, in the online Early Edition of the Proceedings of the National Academy of Sciences. The Ha laboratory team includes lead author Ibrahim Cisse, a graduate student in the department of physics, and recent graduates Burak Okumus and Chirlmin Joo.

In earlier work, Ha and his colleagues created the nanocontainers, which are roughly one-thousandth the diameter of a human hair, from lipid films. They used the nanocontainers, called vesicles, to entrap and study the behavior of large molecules like proteins and DNA. However, the earlier work hit an impasse when researchers realized that there was a limit to the kinds of reactions they could study inside the nanocontainers. The main limiting factor was the inability to introduce chemicals through the impermeable lipid membrane.

Over a period of months, the researchers perfected their technology, ultimately solving the problem and adapting the nanocontainers so that reactants can pass through. To do so, they formed the nanocontainers from a lipid that was transitioning between a liquid and a gel. This instability caused defects in the lipid membrane, which produced pores.

“We could not control the pore size,” Cisse said, “but we were lucky that the lipids we used to form the nanocontainers had pores just big enough to let molecules such as ATP and ions pass, yet small enough to keep large molecules like proteins and DNA inside.” ATP is an energy-containing molecule that powers biochemical reactions.

As a demonstration of the technique, Ha, Cisse, and their colleagues analyzed how a protein called RecA attaches to DNA to form filaments. RecA is a major component of a mechanism for repairing abnormal DNA, and filament formation is central to the repair process. The researchers trapped RecA and a DNA labeled with fluorescent dye molecules inside porous nanocontainers. They then infused ATP into the nanocontainers, and observed in detail how the ATP triggered RecA proteins to interact with DNA to uncoil the DNA to form filaments.

An expert in single-molecule study, Ha is particularly excited about this advance because of its broad applicability and ease of use. “I think this technique will go a long way toward my goal of commoditization of in singulo techniques, getting them out of specialists’ labs to the general research community,” he noted.

“The convenient thing about this technique is that it is a self-assembly process,” Cisse explained. “A researcher need only select the protein, DNA or other biomolecule they want to study, adjust the conditions for lipid encapsulation, and the vesicles will self-assemble, trapping the number of molecules they wish. We have provided information on how to design those conditions.” According to Cisse, the major drawback to the technique is that the pore size cannot be precisely controlled, but he and his colleagues are experimenting with bacterial toxin that introduces pores of a precise size into the nanocontainer membrane.

An innovative nano-sized vesicle encapsulation of single biomolecules (an in singulo technique of studying biomolecular behavior) is being reported by a group under Dr. Taekjip Ha at the University of Illinois at Urbana-Champaign:

In a Howard Hughes Medical Institute laboratory in Illinois, a new kind of “test tube,” one-thousandth the diameter of a human hair and small enough to hold only a few molecules of DNA, is revolutionizing the way researchers observe the behavior of single molecules of DNA, RNA, or proteins. The test tubes are actually bubble-like nanocontainers that are porous to small molecules. Researchers can easily feed needed ions and other chemicals into the ultra-tiny reaction chambers.

Many scientists say that more can be learned about the dynamics of chemical reactions that power biological processes by studying the behavior of individual molecules rather than observing the collective behavior of many molecules, as scientists do now. But techniques for single-molecule studies are limited and often highly specialized. The new nanocontainers, however, will make single-molecule techniques both more accessible and more powerful, said Taekjip Ha, a Howard Hughes Medical Institute investigator at the University of Illinois at Urbana-Champaign. Ha and his Illinois colleagues are the creative force behind the new technology…

“This technique enables study at the single-molecule level of any complex interactions between DNA, RNA and proteins that can be modulated by small molecules,” Ha explained. “These include how cancer drugs interfere with reactions central to the growth of tumors, and the mechanism by which motor proteins enable movement of molecules within the cell. It may even be possible to use this approach for ultrasensitive high-throughput screening of candidate drugs that can inhibit specific interactions between proteins.”

The researchers say their technique can be easily applied in other laboratories, to enable scientists to study individual molecular reactions free of the complications of analyzing reactions in bulk solution. The new approach also improves on other methods used for observing the behavior of single molecules. One of the most common methods required that single molecules be tethered to a surface. With nanocontainers, however, the vesicles themselves are attached to a surface, meaning the molecules inside do not have to be. This simplifies analysis, because the effects of the surface on the reaction do not have to be taken into account, the researchers said.

The researchers published their advance during the week of May 21, 2007, in the online Early Edition of the Proceedings of the National Academy of Sciences…

As a demonstration of the technique, Ha, Cisse, and their colleagues analyzed how a protein called RecA attaches to DNA to form filaments. RecA is a major component of a mechanism for repairing abnormal DNA, and filament formation is central to the repair process. The researchers trapped RecA and a DNA labeled with fluorescent dye molecules inside porous nanocontainers. They then infused ATP into the nanocontainers, and observed in detail how the ATP triggered RecA proteins to interact with DNA to uncoil the DNA to form filaments.

An expert in single-molecule study, Ha is particularly excited about this advance because of its broad applicability and ease of use. “I think this technique will go a long way toward my goal of commoditization of in singulo techniques, getting them out of specialists’ labs to the general research community,” he noted.

“The convenient thing about this technique is that it is a self-assembly process,” Cisse explained. “A researcher need only select the protein, DNA or other biomolecule they want to study, adjust the conditions for lipid encapsulation, and the vesicles will self-assemble, trapping the number of molecules they wish. We have provided information on how to design those conditions.” According to Cisse, the major drawback to the technique is that the pore size cannot be precisely controlled, but he and his colleagues are experimenting with bacterial toxin that introduces pores of a precise size into the nanocontainer membrane.

Source : http://www.hhmi.org/news/ha20070521.html

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Ultracheap Ultrasound for Hospitals in Poor Areas

Ultracheap Ultrasound for Hospitals in Poor Areas

Ultracheap Ultrasound for Hospitals in Poor Areas

An ultra-low cost scanner that can be plugged into any computer to show images of an unborn baby has been developed by Newcastle University engineers.

The hand-held USB device – which is roughly the size of a computer mouse – works in a similar way to existing ultrasound scanners, using pulses of high frequency sound to build up a picture of the unborn child on the computer screen.

However, unlike the technology used in most hospitals across the UK costing anywhere from £20,000-£100,000, the scanner created by Jeff Neasham and Research Associate Dave Graham at Newcastle University can be manufactured for as little as £30-40.

Tested by experts in the Regional Medical Physics Department at the Freeman Hospital, part of the Newcastle upon Tyne Hospitals NHS Foundation Trust, the scanner produces an output power that is 10-100 times lower than conventional hospital ultrasounds.

It is now hoped the device will be used to provide medical teams working in the world’s poorest nations with basic, antenatal information that could save the lives of hundreds of thousands of women and children.

“Here in the UK we take these routine, but potentially lifesaving, tests for granted,” explains Mr Neasham, a sonar expert based in the University’s School of Electrical and Electronic Engineering.

“Imaging to obtain even the simplest information such as the child’s position in the womb or how it is developing is simply not available to women in many parts of the world.

“We hope the very low cost of this device and the fact that it can run on any standard computer made in the last 10 years means basic antenatal imaging could finally be made available to all women.”

Mr Neasham said the original aim had been to make something portable and easy to use that would be affordable in developing countries as well as for some applications in the UK where ultrasound is still considered cost prohibitive.

“Cost was the key,” he explains. “The goal was to produce a device that could be produced for a similar cost to the hand-held Doppler devices (foetal heart monitors) used by most community midwives. Not an easy task when you consider a £20,000 scanner is generally classed as low cost.”

An expert in underwater sonar technology, Mr Neasham has developed systems for imaging the seabed – looking for ship wrecks or specific geographical features – as well as underwater communications and tracking systems.

Drawing on his expertise in sonar signal processing, the design keeps components and hardware costs to an absolute minimum, and works by manually sweeping a transducer over the skin while a focussed image is formed by the PC software.

Funded through an Engineering and Physical Sciences Research Council (EPSRC) Knowledge Transfer Account (KTA) and a Proof of Concept loan from NorthStar Ventures, the scanner requires nothing more than a computer with a USB port in order to work. Mr Neasham said the beauty of this device was that it would complement – rather than replace – the high performance scanners available in hospitals.

“It was my own experience of becoming a father and going through the whole antenatal process that prompted me to start the project,” explains the father-of-two.

“I was sat with my wife looking at our child on the screen, we realised how privileged we were to have access to this kind of care and it was my wife who suggested that I could apply my knowledge from sonar research to try to make this more affordable.”

UN statistics estimate more than 250,000 women die annually from complications during pregnancy or childbirth, almost all of them – 99 per cent – in developing countries. Tragically, most of these deaths are avoidable and a lack of access to equipment is cited as one of the key factors.

Mr Neasham adds: “There is obviously the potential to use it to go beyond obstetrics by using it to diagnose conditions such as gallstones, or other conditions that readily show up with ultrasound imaging. Even vets and farmers are interested in affordable imaging.

The Problem: researchers at Newcastle University have been working on developing a medical ultrasound scanning device, drawing upon many years of innovation in sonar signal processing. Current ‘top-end’ ultrasound devices have a price range of £20,000-£200,000, whilst the ‘low-end’ devices are priced around £5,000. Our market research has identified a growing need and market for ‘low-end’ handheld devices. The aim of this work has been to create a product which could be marketed at a lower price level than current handheld devices and hence enable the use of ultrasound imaging in applications or regions of the world where it is currently cost prohibitive.

Ultrasound DeviceThe Solution: in order to achieve the target price, the device needs to have a low manufacturing cost which places constraints on the component costs. Hence the design philosophy has been to use the minimum possible hardware in the scanning head and connect to any available PC (via USB) to perform signal/image processing and display. Furthermore, the construction of multichannel phased array transducers would far exceed the target cost and so a single transducer element is used. To minimise the cost of electronic circuitry and produce high resolution images from a single fixed focus transducer, several innovative sonar signal processes have been applied. Echo data is gathered as the transducer is manually scanned back and forth across the skin and the PC then performs the focusing and other operations to generate an image up to 3 times per second. In the current prototype the ultrasound frequency and scan dimensions have been chosen to match that of convex array scanners typically used for obstetrics and general abdominal imaging but the parameters could be adapted to suit other applications.

The Opportunity: below we see the comparison of images from high end phased array scanners costing £50,000 – £100,000 (on the left) with similar images generated from the latest prototype for the low cost device (on the right). The first two images are from a 25 week fetal phantom with some anatomical features (such as skull and ventricles). The third image is from a contrast/resolution phantom with point targets (nylon wires) and circular regions of varying contrast in a background which simulates liver tissue. Images compare favourably even before any image post processing (non-linear contrast scaling or speckle filtering) has been applied and enhancements in signal-to-noise ratio, contrast etc are ongoing through improvements in circuitry, software and transducer construction.

The University is seeking collaborative and/or licence opportunities with a suitable industrial partner who can take the next steps of commercializing the technology.

In the modern industrial world, expecting parents have the choice of not only visualizing their child in the womb, but to have a 3D printout of the ultrasound scan to take home. Yet ultrasounds remain expensive enough that much of the world’s poor never see an ultrasound machine, let alone have one used on them to address a medical condition or to check up on a fetus.

Researchers at Newcastle University have been working on developing an ultrasound that can be manufactured significantly cheaper than existing devices. That starts with using an external computer as the display and interface for a USB powered probe, and the rest of the components can be produced for well under $100.

Source : http://www.ncl.ac.uk/business/commercialisation/transfer/biomedical-sciences/ultrasound.htm

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Mevion Proton Therapy System Approved in U.S., Cleared for Firing Up at Initial Hospitals

Mevion Proton Therapy System Approved in U.S., Cleared for Firing Up at Initial Hospitals

Mevion Proton Therapy System Approved in U.S., Cleared for Firing Up at Initial Hospitals

LITTLETON, MA., June 11, 2012 /PRNewswire/–Mevion Medical Systems, Inc., a radiation therapy company dedicated to advancing the treatment of cancer, announced today that it has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System. The MEVION S250 is a first-of-its-kind proton therapy system that provides the same precise, non-invasive treatment advantages and capabilities of complex, large, and costly proton therapy systems but with higher patient throughput, a significantly reduced footprint, improved reliability, and lower implementation and operational costs. The MEVION S250 delivers precise and intense proton beams that physicians can use to treat tumors and lesions or any other condition where radiotherapy is indicated.

The broad adoption of proton therapy has been greatly limited by the enormous cost, large footprint, and technical complexity of traditional proton therapy systems. Powered by a patented TriNiobium Core™, the MEVION S250 proton therapy system redefines the economics, availability, and the future direction of proton therapy, by bringing the management and operation of proton therapy to levels similar to modern X-ray radiation therapy devices. “Completing this very important milestone is a testament to the maturity of the Mevion organization and its ability to manufacture, install and support a safe and effective product,” said Joseph Jachinowski, Chief Executive Officer of Mevion Medical Systems. “We are pleased to receive this clearance from the FDA and now look forward to providing our customers and their patients access to this revolutionary device.”

This clearance enables users of the MEVION S250 to immediately treat patients upon completion of their system installation. The first installation of the MEVION S250 will soon be completed at the Kling Center for Proton Therapy at Barnes Jewish Hospital at Washington University in St. Louis, Missouri.

Mevion will be delivering and installing more than a dozen MEVION S250 proton therapy systems worldwide within the next two years, making it one of the leading providers of proton therapy systems. MEVION S250 installations are also underway at Robert Wood Johnson University Hospital in New Jersey and Oklahoma University in Oklahoma. Additional sites in Florida and California will follow these installations.

Earlier this year, the MEVION S250 received CE certification, which gives Mevion the ability to market, sell, import, and install proton therapy systems in the European Union and other regions where the CE Marking is recognized.

About Mevion Medical Systems

Mevion Medical Systems, Inc. is a radiation therapy company dedicated to advancing the treatment of cancer. As the pioneering developer of proton therapy systems, Mevion provides innovative, safe, and effective solutions by transforming advances in medical technology and science into practical clinical reality.

Mevion’s flagship product, the MEVION S250 Proton Therapy System, is designed to preserve all of the treatment benefits of traditional proton therapy systems while removing the obstacles of size, cost, and complexity. Realizing this vision, Mevion has forever changed the economics and accessibility of proton therapy worldwide.

Founded in 2004, Mevion is a privately held company headquartered in the Boston metropolitan area with international offices in the United Kingdom and Japan.

Introducing the MEVION S250

High Energy Cancer Care™

The confluence of elegance, precision, safety, and efficiency is defining the future of proton therapy. Mevion Medical Systems introduces the MEVION S250 Proton Therapy System.

Designed to preserve all of the treatment benefits of conventional proton treatment systems, the MEVION S250 removes the obstacles of size, cost and complexity that have limited adoption of proton therapy. Precise, safe, efficient, and practical – the MEVION S250™ is a truly elegant solution that is making proton therapy readily accessible to the pediatric and adult cancer patients who can now benefit from the power of High Energy Cancer Care.

The MEVION S250 Proton Therapy System is USFDA 510(k) cleared and complies with MDD/CE requirements.

Mevion Medical out of Littleton, MA received the European CE Mark for its MEVION S250 Proton Therapy System. Proton therapy’s advantage over traditional radiation is that it allows for precise targeting of tumors so that energy is deposited almost exclusively at the target without damaging tissue on the way to and away from the treatment area.

The real limiting issues with proton therapy is the cost of the systems and their large size because they are powered by synchrocyclotrons. TriNiobium Core MEVION S250 Proton Therapy Cleared in EuropeBy managing to build a compact accelerator (6 ft (1.8 m) in diameter) that can deliver protons at 250 MeV to a depth of up to 32 cm, the company believes it can bring down the cost of this technology and make it affordable to more hospitals.

Proton beam radiotherapy can accurately deliver targeted radiation doses with complete proton energy absorption at predictable tissue depth, thus allowing precise radiation delivery adjacent to critical structures and lower radiation doses to healthy structures. The availability of proton therapy has remained very limited however, due to the enormous cost, large footprint, and technical complexity of traditional proton therapy systems.

CE Marking of the MEVION S250 gives hospitals and cancer treatment centers throughout the European Union, and other regions where CE Marking is recognized, the ability to order, install, and treat patients with this revolutionary medical device. Powered by a TriNiobium Core™, the MEVION S250 significantly reduces the cost, size and complexity of proton therapy systems to levels similar to modern X-ray radiation therapy devices, and brings accessibility, affordability and practicality to proton therapy.

Mevion is concurrently installing three MEVION S250 Proton Therapy Systems in the United States. The first site at the Siteman Cancer Center in Barnes Jewish Hospital, at Washington University in St. Louis Missouri accepted delivery of its superconducting synchrocyclotron in October of 2011 and is now producing a powerful 250 MeV energy beam. The second and third installations at Robert Wood Johnson University Hospital in New Brunswick, NJ and Oklahoma University, OK are underway and scheduled to be completed later this year.

Source : http://www.mevion.com/news/67-fda-approved

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Researchers Develop 3D Visualization Method for Microscopic Histopathological Specimens

Researchers Develop 3D Visualization Method for Microscopic Histopathological Specimens

Researchers Develop 3D Visualization Method for Microscopic Histopathological Specimens

Philadelphia, PA, April 15, 2012 – Researchers have developed a novel, easy-to-use system for three-dimensional (3D) reconstruction and examination of tissues at microscopic resolution, with the potential to significantly enhance the study of normal and disease processes, particularly those involving structural changes. The new approach, using conventional histopathological methods, is described in the May issue of The American Journal of Pathology.

“The use of 3D imaging technology to study structure, function, and disease manifestations has been limited because of low resolution, and the time and difficulty associated with acquiring large numbers of images with a microscope,” says lead investigator Dr. Darren Treanor, University of Leeds and the Leeds Teaching Hospitals NHS Trust, United Kingdom. “Our system can integrate tissue micro-architecture and cellular morphology on large tissue samples. It can be used by technical or medical staff in a histopathology laboratory without input from computing specialists.”

Developed by Dr. Derek Magee at the University of Leeds, the system utilizes automated virtual slide scanners to generate high-resolution digital images and produce 3D tissue reconstructions at a cellular resolution level and can be used on any stained tissue section. It is based on a general image based-registration algorithm and operates using an integrated system that requires minimal manual intervention once the slides are sectioned, stained, and mounted. The virtual slide scanners digitize the tissue automatically, the software communicates with the software serving the image, which aligns the images, and produces visualization in one integrated package. The user can manually select a region, zoom in and re-register the area to get a higher resolution image of microscopic features.

The authors have applied the system to over 300 separate 3D volumes from eight different tissue types, using a total of 5,500 virtual slides. They describe cases that illustrate the possible applications of the system. For example, a 3D volume rendering of a mouse embryo demonstrates that the method could be useful for providing anatomical and expression data and for creating a “virtual archive” of 3D transgenic models. A 3D volume rendering of sections from a human liver containing a deposit of metastatic colorectal carcinoma adjacent to a blood vessel could provide insight into tumor vasculature and its response to anti-angiogenic agents. A 3D visualization of cirrhotic human liver infected with hepatitis C demonstrates the software’s potential to provide information on disease development and aid diagnosis.

“Many fields, including tumor biology, embryology, and cardiovascular disease could benefit from correlation of structure and function in three dimensions, but getting high quality 3D reconstructions has always been difficult” says Dr. Treanor. “We have demonstrated that our software is accurate and robust enough to use without significant computer science input. This system provides the opportunity for increasing use of 3D histopathology as a routine research tool.”

Notes for editors

“Towards Routine Use of 3D Histopathology As a Research Tool,” by N. Roberts, D. Magee, Y. Song, K. Brabazon, M. Shires, D. Crellin, N.M. Orsi, R. Quirke, P. Quirke, and D. Treanor (DOI: External link http://dx.doi.org/10.1016/j.ajpath.2012.01.033). It will appear in The American Journal of Pathology, Volume 180, Issue 5 (May 2012) published by Elsevier.

Full text of the article is available to credentialed journalists upon request; contact David Sampson at +1 215 239 3171 or ajpmedia@elsevier.com. Journalists wishing to interview the authors may contact Paula Gould, Communications and Press Office, University of Leeds, Tel: +44 113 34 38059, p.a.gould@leeds.ac.uk.

About The American Journal of Pathology

The American Journal of Pathology (External link http://ajp.amjpathol.org), official journal of the American Society for Investigative Pathology, seeks to publish high-quality, original papers on the cellular and molecular biology of disease. The editors accept manuscripts that advance basic and translational knowledge of the pathogenesis, classification, diagnosis, and mechanisms of disease, without preference for a specific analytic method. High priority is given to studies on human disease and relevant experimental models using cellular, molecular, animal, biological, chemical, and immunological approaches in conjunction with morphology.

The leading global forum for reporting quality original research on cellular and molecular mechanisms of disease, The American Journal of Pathology is the most highly cited journal in Pathology with an Impact Factor of 5.224 according to Thomson Reuters Journal Citation Reports® 2010.

About the University of Leeds

One of the UK’s largest medical, health and bioscience research bases, the University of Leeds delivers world leading research in medical engineering, cancer, cardiovascular studies, epidemiology, molecular genetics, musculoskeletal medicine, dentistry, psychology and applied health. Treatments and initiatives developed in Leeds are transforming the lives of people worldwide with conditions such as diabetes, HIV, tuberculosis and malaria (External link www.leeds.ac.uk). The Virtual Pathology team at Leeds is dedicated to high quality digital slide scanning, hosting and research (External link http://www.virtualpathology.leeds.ac.uk).

About Leeds Teaching Hospitals NHS Trust

The Leeds Teaching Hospitals NHS Trust is one of the largest in England and includes two major teaching hospitals, Leeds General Infirmary and St James’s University Hospital, with a strong focus on research and education. It has a total budget of nearly £1 billion, employs over 14,500 staff across six main sites, and treats well over a million patients a year.

About Elsevier

Elsevier is a world-leading provider of scientific, technical and medical information products and services. The company works in partnership with the global science and health communities to publish more than 2,000 journals, including External link The Lancet and External link Cell, and close to 20,000 book titles, including major reference works from Mosby and Saunders. Elsevier’s online solutions include External link SciVerse ScienceDirect, External link SciVerse Scopus, External link Reaxys, External link MD Consult and External link Mosby’s Nursing Suite, which enhance the productivity of science and health professionals, and the External link SciVal suite and External link MEDai’s Pinpoint Review, which help research and health care institutions deliver better outcomes more cost-effectively.

A global business headquartered in Amsterdam, External link Elsevier employs 7,000 people worldwide. The company is part of External link Reed Elsevier Group PLC, a world-leading publisher and information provider, which is jointly owned by Reed Elsevier PLC and Reed Elsevier NV. The ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).

Researchers from the University of Leeds in the United Kingdom have developed a system for three-dimensional reconstruction and examination of histopathological specimens at microscopic resolution. Similar to the fancy 3D reconstructions that are now often performed on MRI or CT scans, this method adds a new dimension to tissue visualization, giving new insights into tissue structure and how this is affected by disease processes.

Histopathological examinations are normally performed on thin slices of tissue under the microscope (or on a computer screen after digitization), limiting the view to one section of a 2D tissue sample at a time. 3D imaging in pathology up till now has been limited because of low resolution, and the time and difficulty associated with acquiring large numbers of images with a microscope. The new system uses samples prepared using standard histological techniques and can be operated by existing technical or medical lab staff. A description of how the system works, from the press release:

Developed by Dr. Derek Magee at the University of Leeds, the system utilizes automated virtual slide scanners to generate high-resolution digital images and produce 3D tissue reconstructions at a cellular resolution level and can be used on any stained tissue section. It is based on a general image based-registration algorithm and operates using an integrated system that requires minimal manual intervention once the slides are sectioned, stained, and mounted. The virtual slide scanners digitize the tissue automatically, the software communicates with the software serving the image, which aligns the images, and produces visualization in one integrated package. The user can manually select a region, zoom in and re-register the area to get a higher resolution image of microscopic features.

The image above shows some of the results: axial and coronal views, and 3D volume rendition and 3D visualization of anatomical features of a mouse embryo (A), metastatic colorectal carcinoma in human liver tissue (B), cirrhotic human liver tissue infected with hepatitis C (C), and a single rat glomerulus (D). The work is published in the May issue of The American Journal of Pathology.

Source : http://www.elsevier.com/wps/find/authored_newsitem.cws_home/companynews05_02300

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GORE Hybrid Vascular Prosthetic Graft is Green Light

GORE Hybrid Vascular Prosthetic Graft is Green Light

GORE Hybrid Vascular Prosthetic Graft is Green Lighted in EU

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates (Gore) has received CE Mark for the GORE® Hybrid Vascular Graft. The graft is designed to expand treatment options for optimal outflow by maximizing the number of access sites available. Twelve month follow-up data for newly created access implants demonstrates a trend towards significant improvement in functional graft patency and reduction in seroma, as compared to historical graft data. Since commercialization, there have been more than 2500 successful implants of the GORE Hybrid Vascular Graft in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, and other vascular procedures.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility”

The GORE Hybrid Vascular Graft, which received FDA clearance in 2010, is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels impacted by aortic aneurysmal, peripheral vascular and end stage renal disease. The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft has been used to create new access sites in anatomical locations that would have otherwise been abandoned, preserving the amount of access sites available throughout the patient’s long-term therapy.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility,” said Jean Bismuth, MD, Assistant Professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “The GORE Hybrid Vascular Graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics.”

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft of its kind that incorporates CARMEDA® BioActive Surface (CBAS® Surface) with covalently bonded heparin, resulting in a proven thromboresistant surface.

“Receiving CE Mark for the GORE Hybrid Vascular Graft demonstrates our commitment to providing physicians with innovative technology that can expand treatment options and improve patient outcomes worldwide,” said Chuck Biggerstaff, associate with the Gore Venous Access Business.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 15th consecutive year. www.goremedical.com.

Products listed may not be available in all markets. GORE® and designs are trademarks of W. L. Gore & Associates. CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc. AR0383-EN1 AUGUST 2012

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates (Gore) has received CE Mark for the GORE® Hybrid Vascular Graft. The graft is designed to expand treatment options for optimal outflow by maximizing the number of access sites available. Twelve month follow-up data for newly created access implants demonstrates a trend towards significant improvement in functional graft patency and reduction in seroma, as compared to historical graft data. Since commercialization, there have been more than 2500 successful implants of the GORE Hybrid Vascular Graft in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, and other vascular procedures.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility”

The GORE Hybrid Vascular Graft, which received FDA clearance in 2010, is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels impacted by aortic aneurysmal, peripheral vascular and end stage renal disease. The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft has been used to create new access sites in anatomical locations that would have otherwise been abandoned, preserving the amount of access sites available throughout the patient’s long-term therapy.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility,” said Jean Bismuth, MD, Assistant Professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “The GORE Hybrid Vascular Graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics.”

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft of its kind that incorporates CARMEDA® BioActive Surface (CBAS® Surface) with covalently bonded heparin, resulting in a proven thromboresistant surface.

“Receiving CE Mark for the GORE Hybrid Vascular Graft demonstrates our commitment to providing physicians with innovative technology that can expand treatment options and improve patient outcomes worldwide,” said Chuck Biggerstaff, associate with the Gore Venous Access Business.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 15th consecutive year. www.goremedical.com.

Products listed may not be available in all markets. GORE® and designs are trademarks of W. L. Gore & Associates. CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc. AR0383-EN1 AUGUST 2012

W. L. Gore & Associates received CE Mark approval for its GORE Hybrid Vascular Graft in the European Union, a device for replacing or bypassing damaged vasculature due to aortic aneurysms, peripheral vascular and end stage renal disease.

GORE Hybrid Vascular Graft ePTFE vascular prosthesis GORE Hybrid Vascular Prosthetic Graft is Green Lighted in EUThe device has received FDA approval back in 2010 and has already been used in over 2500 procedures.

More about the graft from the announcement:

The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft has been used to create new access sites in anatomical locations that would have otherwise been abandoned, preserving the amount of access sites available throughout the patient’s long-term therapy.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility,” said Jean Bismuth, MD, Assistant Professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “The GORE Hybrid Vascular Graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics.”

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft of its kind that incorporates CARMEDA® BioActive Surface (CBAS® Surface) with covalently bonded heparin, resulting in a proven thromboresistant surface.

source : http://www.businesswire.com/news/home/20120820005056/en/Gore-Receives-CE-Mark-GORE%C2%AE-Hybrid-Vascular

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Nonsurgical circumcision device for adults to be tested in Africa

Nonsurgical circumcision device for adults to be tested in Africa

“PrePex, a bloodless circumcision device for adults, will be tested in at least nine African countries in the next year, according to the backers of the tests,” the New York Times reports. PEPFAR “will pay for PrePex circumcisions for about 2,500 men in Lesotho, Malawi, South Africa, Tanzania and Uganda, said Dr. Jason B. Reed, a technical adviser to the plan,” the newspaper writes. “The Bill & Melinda Gates Foundation will pay for similar studies in Kenya, Mozambique, South Africa, Zambia and Zimbabwe,” it adds. According to the New York Times, the device “was approved by the Food and Drug Administration in January, and World Health Organization approval is expected soon.” The newspaper notes, “No surgeon is needed for the procedure; a two-nurse team slides a grooved ring inside the foreskin and guides a rubber band to compress the foreskin in the groove,” and adds, “After a week, the dead foreskin falls off like the stump of a baby’s umbilical cord or can be painlessly clipped off, said Tzameret Fuerst, chief executive of PrePex” (McNeil, 8/13).

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

source : http://www.news-medical.net/news/20120815/Nonsurgical-circumcision-device-for-adults-to-be-tested-in-Africa.aspx

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Conformable GORE TAG Thoracic Endoprosthesis to Save Young Lives

Conformable GORE TAG Thoracic Endoprosthesis to Save Young Lives

Conformable GORE TAG Thoracic Endoprosthesis to Save Young Lives

Conformable GORE® TAG® Thoracic Endoprosthesis Designed for Endovascular Repair of the Descending Thoracic Aorta Provides Conformability without Compromise

W. L. Gore & Associates, Inc. (Gore) announced that the US Food and Drug Administration (FDA) has approved the Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of isolated lesions of the descending thoracic aorta, including traumatic aortic transections. The durable endoprosthesis is the first such device to receive approval for an indication that includes traumatic transection. The Conformable GORE TAG Thoracic Endoprosthesis is designed for multiple thoracic etiologies. Extensive clinical research has been conducted with the device in the areas of aneurysm and trauma and there is an ongoing US trial investigating its use for the treatment of acute dissection.

A transection is a tear in the wall of the aorta, typically the result of a motor vehicle accident, that causes internal bleeding and is frequently fatal. Open surgical repair was the only treatment option prior to the approval.

The Conformable GORE TAG Device is the only FDA approved thoracic endoprosthesis specifically designed to treat the anatomy of young trauma patients, with the ability to treat down to 16 mm aortas and extremely tapered anatomy. The device offers conformability and ease of use, while accommodating tapered anatomy and resisting compression. The broad oversizing window for the device ranges from 6 to 33 percent, allowing physicians to choose the appropriate oversizing for the patient anatomy.

Mark Farber, MD, Director at the Aortic Center at the University of North Carolina at Chapel Hill, served as national principal investigator for the Conformable GORE TAG Device in the Traumatic Aortic Transection Trial (Gore TAG 08-02). According to Dr. Farber, “We gained a great deal of insight and knowledge from the traumatic transection trial for Conformable GORE TAG Device that ultimately led to the expansion of indications. Through the research, we were able to illustrate the capabilities of the Conformable GORE TAG Device, and help to demonstrate that thoracic endografts can offer patients with traumatic aortic transection a less invasive alternative to open surgical repair.”

The Conformable GORE TAG Thoracic Endoprosthesis is delivered via catheter and inserted into the femoral artery through a small incision in the groin and carefully guided up the leg artery through the abdomen into the chest and to the site of the transection. The device is available in diameters of 21-45 mm, allowing for the treatment of patients with aortic diameters of 16-42 mm. Tapered device configurations are also available.

“We are proud to deliver to endovascular specialists and their patients the first FDA approved minimally invasive treatment option for treating traumatic aortic transection,” said David Abeyta, Gore Aortic Business Leader. “The Conformable GORE TAG Device provides an optimal fit and maximum conformability for each patient’s anatomy.”

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 14th consecutive year.

Traditional treatment of diseases of the thoracic aorta has involved high-risk surgery resulting in long hospital stays and painful recoveries. For more than a decade, Gore has worked alongside physicians in the evolution of the GORE® TAG® Thoracic Endoprosthesis. Our collaboration has resulted in the distribution of more than 59,000 devices for the treatment of more than 34,700 patients worldwide.

The GORE® TAG® Device has remained the leading option for less invasive treatment of thoracic aneurysms and lesions with a proven safety record, which is supported by more than ten years of worldwide clinical data. The next generation Conformable GORE® TAG® Device was engineered for flexibility and conformability in tortuous anatomy to meet the needs of individual patients.

The device is the only durable ePTFE thoracic endoprosthesis that offers conformability and ease of use, while accommodating tapered anatomy, resisting compression and maintaining patency in small diameter thoracic aortas characteristic of young patients. The Conformable GORE® TAG® Device has an exclusive oversizing window range from 6–33%, allowing physicians to choose the appropriate radial force to create the appropriate radial fit of the device for the patient anatomy and specific etiology.

The device is available in diameters of 21–45 mm, allowing for the treatment of patients with aortic diameters of 16–42 mm. Tapered device configurations are also available. The simple, single-step deployment system provides flexibility for navigating tortuous anatomy. Paired with the GORE® DrySeal Sheath, which optimizes control with minimal blood loss, the Conformable GORE® TAG® Thoracic Endoprosthesis exemplifies Gore’s continued commitment to innovative solutions intended to maximize patient outcomes.

Thanks to a freshly issued FDA approval, W. L. Gore & Associates will be bringing its Conformable GORE TAG Thoracic Endoprosthesis to the U.S. market. The device is designed for young patients when addressing isolated lesions of the thoracic aorta and can even be used for life threatening traumatic transections of the aorta, which till now required a fully open thoracic approach.

The Conformable GORE TAG Device is the only FDA approved thoracic endoprosthesis specifically designed to treat the anatomy of young trauma patients, with the ability to treat down to 16 mm aortas and extremely tapered anatomy. The device offers conformability and ease of use, while accommodating tapered anatomy and resisting compression. The broad oversizing window for the device ranges from 6 to 33 percent, allowing physicians to choose the appropriate oversizing for the patient anatomy.

The Conformable GORE TAG Thoracic Endoprosthesis is delivered via catheter and inserted into the femoral artery through a small incision in the groin and carefully guided up the leg artery through the abdomen into the chest and to the site of the transection. The device is available in diameters of 21-45 mm, allowing for the treatment of patients with aortic diameters of 16-42 mm. Tapered device configurations are also available.

Source : http://www.goremedical.com/mpd?action=record&R=1276629432006&rg=na

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InTouch and iRobot Develop Next Generation Telemedicine Device

InTouch and iRobot Develop Next Generation Telemedicine Device

InTouch and iRobot Develop Next Generation Telemedicine Device

First to combine the latest in telemedicine with state-of-the-art autonomous navigation and mobility

SANTA BARBARA, CA (July 24, 2012) – InTouch Health, the leader in acute care remote presence telemedicine, and iRobot (NASDAQ: IRBT), a leader in delivering robotic technology-based solutions, today announced the companies will unveil the breakthrough RP-VITA (Remote Presence Virtual + Independent Telemedicine Assistant) at the InTouch Health 7th Annual Clinical Innovations Forum, to be held July 26 – 28 in Santa Barbara, CA. The RP-VITA is the first remote presence solution for patient care that combines the latest in telemedicine technology from InTouch Health with the latest in autonomous navigation and mobility developed for the iRobot Ava™ mobile robotics platform. For the hospital market, the RP-VITA improves patient care by ensuring the physician is in the right place at the right time and has access to the necessary clinical information to take immediate action.

The RP-VITA is a result of a joint development and licensing agreement the two best-of-breed companies announced a year ago and broadened earlier this year. An expandable telemedicine technology platform, the RP-VITA is the remote presence device component of a total acute care telemedicine solution which includes an integrated ecosystem of technologies and support infrastructure, all part of the InTouch® Telemedicine System. The RP-VITA will be sold by InTouch Health as its new flagship remote presence device. iRobot will continue to explore adjacent market opportunities for robots like the RP-VITA and iRobot Ava.

“The hospital industry is undergoing significant changes, and as we strive to maintain our culture of ensuring an excellent patient experience, we face significant pressure on reducing operating expenses and managing staffing and resources. New technology such as the RP-VITA that dramatically increases the effectiveness and extends the reach of healthcare professionals is required,” said Richard Afable, M.D., M.P.H., President of and CEO of Hoag Memorial Hospital Presbyterian. Hoag, Ronald Reagan UCLA Medical Center and Children’s Hospital of Orange County (CHOC) participated in clinical validations as part of the U.S. Food and Drug Administration (FDA) review process for the RP-VITA.

The RP-VITA offers doctors the ability to take command of any clinical, patient or care team management process remotely. It provides a new level of mobility, utility and ease of use for healthcare professionals in the acute care market.

“The RP-VITA raises the bar for overseeing patient care remotely and allows me to proactively control a situation as if I were there,” said Jason Knight, M.D., Director of the CHOC Transport Program and Assistant Clinical Professor at the University of California, Irvine. “The robot is so easy to use that I can forget about the technology and just focus on the clinical needs at hand.” Dr. Knight led the clinical validation process at CHOC.

Some of the RP-VITA’s new and unique features include:

An enhanced navigation capability that enables the RP-VITA to better manage driving and navigation elements so the health care professional can put more focus on patient care tasks. State-of-the-art mapping and Obstacle Detection Obstacle Avoidance (ODOA) technologies allow safe, fast and highly flexible navigation in a clinical environment.

An additional capability for the RP-VITA incorporates autonomous navigation and is being submitted to the FDA for 510(k) clearance. This capability will allow a remote clinician or bedside nurse to send the RP-VITA to a target destination with a single click, enabling a number of breakthrough clinical applications. InTouch Health anticipates clearance for this feature in Q4 2012.

Real-time access to important clinical data, enabling a range of new workflow improvements for physicians, nurses and other patient care team members. For example, the RP-VITA can be integrated with live patient data from the electronic medical record and is equipped with the ability to connect with diagnostic devices such as otoscopes and ultrasound. It comes equipped with the latest electronic stethoscope.

A new, simple to use iPad user interface will enable quick and easy navigation to anywhere the RP-VITA needs to go, as well as interaction with the patient, family and care team.

InTouch Health envisions that the expandable RP-VITA platform will provide additional value in orchestrating team-wide care, as a clinical assistant to enhance efficiency and quality, and as a patient advocate to enhance the care experience.

“The RP-VITA is a game changer for acute care telemedicine, and it will become the cornerstone for many new clinical applications and uses. The RP-VITA is a platform that will immediately improve existing healthcare delivery models, and through additional collaboration and development will create new clinical innovations that we can only imagine,” said Yulun Wang, Ph.D., InTouch Health’s Chairman and CEO.

“While this represents our first foray into the healthcare market, the RP-VITA represents a robust platform, and we foresee many future opportunities in adjacent markets. Robots like the RP-VITA and iRobot Ava are easy to use and able to autonomously navigate real world environments. They lend themselves to a wide variety of applications in home, retail, industrial and other settings,” said Colin Angle, Chairman and CEO of iRobot.

In January, iRobot invested $6 million in InTouch Health. This expanded the joint development and licensing agreement formed in 2011, which was established to explore opportunities for healthcare applications on iRobot platforms, including iRobot Ava.

The RP-VITA will be added to the suite of devices included in the FDA-cleared Class II InTouch® Telemedicine System. This clearance includes active patient monitoring in high acuity environments where immediate clinical action may be required, such as in the ICU and emergency department to facilitate the rapid assessment and treatment of stroke and other time critical conditions.

About the Clinical Innovations Forum

InTouch Health’s 7th Annual Remote Presence Clinical Innovations Forum (RPCIF) is an annual conference focused on the science, technology, education, planning and sharing of best practices for telemedicine care delivery networks. It will be attended by over 350 hospital physicians, administrators and industry executives, many of whom currently utilize the company’s remote presence solutions. InTouch Health’s Yulun Wang and iRobot’s Colin Angle are keynote speakers, and the Forum faculty includes over 30 clinical and non-clinical leaders from throughout the hospital industry. Some faculty members advised InTouch Health throughout the RP-VITA development process on clinical user and operational requirements. The Forum takes place in Santa Barbara, Calif., from July 26 – 28, at the Fess Parker Doubletree. Registration is required to attend.

About Acute Care Telemedicine

Acute care telemedicine solutions extend the physician’s or healthcare professional’s reach to manage emergent and acute medical situations remotely, thereby removing critical time and distance barriers. It ensures the right professionals are in the right place at the right time, with the right expertise and the right information to optimize patient care. Remote presence telemedicine plays a key “force multiplying” role by enabling the healthcare workforce to meet the ever-increasing demands of the healthcare system. Utilizing telemedicine can decrease complications for patients in areas of high acuity like the critical care unit, as well as aid in time-sensitive treatment decisions for emergency care. In short, with remote expertise available at a moment’s notice, telemedicine enables improved patient safety and quality of care, reduces costs and increases hospital efficiencies.

About InTouch Health

InTouch Health, privately held and headquartered in Santa Barbara, CA, has led the emergence of acute care Remote Presence telemedicine that effectively extends the physician’s reach to manage patient care, thereby removing critical time and distance barriers. The company offers the InTouch® Telemedicine System, the world’s only total solution for acute care telemedicine applications where specialists are required to take immediate clinical action. The System integrates end-to-end telemedicine solutions, its SureConnect® cloud-based network infrastructure, clinical apps, data, industry-leading 24×7 technical support and clinical consulting services. Through a single portal, physicians can access a host of purpose-built, FDA-cleared telemedicine devices to provide care anywhere across the continuum, from EDs, ICUs, procedure rooms and patient wards to clinics, ambulances and homes. InTouch Health has nearly 600 hospital locations on six continents enrolled in its remote presence network for the delivery of telemedicine services such as neurology, critical care, cardiology, trauma, pediatrics, neonatology, behavioral health, language translations, and clinical education and surgical/procedure mentoring. For more information about InTouch Health, please visit www.intouchhealth.com.

About iRobot Corp.

iRobot designs and builds robots that make a difference. The company’s home robots help people find smarter ways to clean, and its defense & security robots protect those in harm’s way. iRobot’s consumer and military robots feature iRobot Aware® robot intelligence systems, proprietary technology incorporating advanced concepts in navigation, mobility, manipulation and artificial intelligence. For more information about iRobot, please visit www.irobot.com.

For iRobot Investors

Certain statements made in this press release that are not based on historical information are forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release contains express or implied forward-looking statements relating to, among other things, iRobot Corporation’s expectations concerning management’s plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. iRobot Corporation undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by iRobot Corporation, see the disclosure contained in our public filings with the Securities and Exchange Commission including, without limitation, our most recent Annual Report on Form 10-K.

InTouch Health, a big name in telemedicine devices, and iRobot, the famous maker of robotic Roomba vacuums and battlefield robots, have teamed up to bring their respective expertise together in building a single device, the RP-VITA (Remote Presence Virtual + Independent Telemedicine Assistant).

InTouch supplied the telemedicine part and iRobot developed the motion and navigation aspects of the RP-VITA, which uses sensors and smart algorithms to help a physician move through a hospital’s complicated terrain. There’s even talk of a “single click” feature to be approved by the FDA that seems to allow the RP-VITA to autonomously navigate between patients in a hospital that the remote physician might not even know the topography of.

irobot intouch InTouch and iRobot Develop Next Generation Telemedicine DeviceNew features introduced in the RP-VITA from the announcement:

An enhanced navigation capability that enables the RP-VITA to better manage driving and navigation elements so the health care professional can put more focus on patient care tasks. State-of-the-art mapping and Obstacle Detection Obstacle Avoidance (ODOA) technologies allow safe, fast and highly flexible navigation in a clinical environment.

An additional capability for the RP-VITA incorporates autonomous navigation and is being submitted to the FDA for 510(k) clearance. This capability will allow a remote clinician or bedside nurse to send the RP-VITA to a target destination with a single click, enabling a number of breakthrough clinical applications. InTouch Health anticipates clearance for this feature in Q4 2012.

Real-time access to important clinical data, enabling a range of new workflow improvements for physicians, nurses and other patient care team members. For example, the RP-VITA can be integrated with live patient data from the electronic medical record and is equipped with the ability to connect with diagnostic devices such as otoscopes and ultrasound. It comes equipped with the latest electronic stethoscope.

A new, simple to use iPad user interface will enable quick and easy navigation to anywhere the RP-VITA needs to go, as well as interaction with the patient, family and care team.

Source : http://www.irobot.com/en/us/Company/Press_Center/Press_Releases/Press_Release.aspx?n=072412-InTouch

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Gene therapy achieves early success against hereditary bleeding disorder

Gene therapy achieves early success against hereditary bleeding disorder

Hemophilia is a rare blood-clotting disease famously known for afflicting the royal families throughout Europe. One type, Hemophilia B, also called Christmas disease after Stephen Christmas, the first patient described with it, is caused by a defect in the eponymous gene on the X chromosome that leads to less than 1 percent of normal expression of Factor IX (FIX), an important blood clotting factor. Hence patients, who are usually male because they only have one X chromosome, require regular intravenous transfusions of Factor IX to prevent internal bleeding, or hemorrhage. These injections cost an individual patient about $300,000 a year, which may add up to around $20 million over a lifetime.

That may soon change due to a “landmark” study published this weekend in the New England Journal of Medicine. An international research team led by scientists at the University College London successfully used gene therapy (adeno-associated viral vectors) to replace the defective or missing copy of the FIX gene in a small cohort of patients, prompting the New York Times to write that Hemophilia B may be “the first well-known disease to appear treatable by gene therapy, a technique with a 20-year record of almost unbroken failure.” The viral vector used by the team inserted the replacement gene into the liver cells of the hemophiliac patients, carefully avoiding the chromosomes to reduce the risk of inducing cancerous mutations, and induced physiologically relevant expression of the coagulation factor up to 22 months post-therapy. As the authors summarize in NEJM:hemophilia-B-gene-therapy

The development and widespread use of clotting factor concentrates for the treatment of hemophilia in the early 1970s dramatically improved the life expectancy for patients with the disease. Subsequent development of recombinant clotting factor concentrates has improved their safety profile, but there remains a strong interest in treatment strategies that would eliminate the need for long-term intravenous infusions and that would be available to the hemophilia population throughout the world. This study documents a critical step toward that goal and shows that sustained therapeutic expression of a transferred factor IX gene can be achieved in humans. The increase in FIX levels in our study participants was roughly dose-dependent, with the high dose of the vector scAAV2/8-LP1-hFIX (2×1012 vg per kilogram) mediating peak expression at 8 to 12% of normal levels. After peripheral-vein administration of scAAV2/8-LP1-hFIXco, four of the six participants were able to stop using prophylaxis with FIX concentrate without having spontaneous hemorrhage, even when they undertook activities that had provoked bleeding in the past. For the other two participants, the interval between prophylactic FIX concentrate injections was extended, but prophylaxis was not completely discontinued…

In summary, we have found that a single peripheral-vein infusion of our scAAV2/8-LP1-hFIXco vector consistently leads to long-term expression of the FIX transgene at therapeutic levels, without acute or long-lasting toxicity in patients with severe hemophilia B. Immune-mediated, AAV-capsid–induced elevations in aminotransferase levels remain a concern, but our data suggest that this process may be controlled by a short course of glucocorticoids, without loss of transgene expression. Follow-up of larger numbers of patients for longer periods of time is necessary to fully define the benefits and risks and to optimize dosing. However, this gene-therapy approach, even with the associated risk of transient hepatic dysfunction, has the potential to convert the severe bleeding phenotype into a mild form of the disease or to reverse it entirely.

Study of gene therapy developed at UCL and St. Jude Children’s Research Hospital offers first proof adults with haemophilia B benefit from treatment, reducing need for injections with clotting factor to prevent bleeds.

Symptoms improved significantly in adults with the bleeding disorder haemophilia B following a single treatment with gene therapy developed by researchers at St. Jude Children’s Research Hospital in Memphis, US and demonstrated to be safe in a clinical trial conducted by UCL.

The findings of the six-person study mark the first proof that gene therapy can reduce disabling, painful bleeding episodes in patients with the inherited blood disorder. Results of the Phase I study appear online ahead of print today in the New England Journal of Medicine. The research is also scheduled to be presented on 11 December at the 53rd annual meeting of the American Society of Hematology in San Diego, US.

Four study participants stopped receiving protein injections to prevent bleeding episodes after undergoing the therapy and have not suffered spontaneous bleeding. Several have also participated in marathons and other activities that would have been difficult prior to gene therapy. The study participants were all treated at the Royal Free Hospital in London under the care of Professor Edward Tuddenham, a pioneer in the field of blood coagulation and a study co-author.

“The first patient has been followed for the longest time, and his levels have remained at 2% for more than 18 months. These results are highly encouraging and support continued research. More patients are scheduled to be enrolled in future trials scheduled to begin later this year,” Davidoff said.

One of the participants who received the highest dose of the vector underwent successful, short-term steroid treatment after his liver enzymes rose slightly after the vector infusion. The rise signalled mild liver damage. The volunteer remained otherwise healthy, his Factor IX levels remain above pre-infusion levels and his liver enzymes have returned to normal. Liver enzymes also rose slightly, but remained in the normal range, for the other participant who received the highest dose of the vector. The participant also received a short course of steroids.

Researchers believe an immune response targeting the vector triggered the elevated enzyme levels. A similar response was reported in earlier gene therapy trials conducted by other investigators using a different vector.

The vector used in this study was produced at the Good Manufacturing Practices (GMP) facility on the St. Jude campus. The GMP operates under government-approved manufacturing guidelines and produces highly specialized medicines, vaccines and other products that pharmaceutical companies are reluctant to pursue. The vector can also now be produced in a similar facility at UCL.

The research was funded in part by The Katharine Dormandy Trust, Medical Research Council, Wellcome Trust, NHS Blood and Transplant and the UCLH/UCL National Institute for Health Research Biomedical Research Centre, all in the UK. In the US, the research was funded by the National Institutes of Health, the Assisi Foundation of Memphis and ALSAC.

Source: http://www.ucl.ac.uk/news/news-articles/1112/111209-haemophilia-gene-therapy-study,http://medgadget.com/2011/12/hope-for-hemophiliacs-gene-therapy-stops-the-bleeding.html

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