Posts Tagged ‘new technology’

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Integra LifeSciences Announces Launch of the Integra(R) Allograft Wedge System for Extremity Reconstruction

Integra LifeSciences Announces Launch of the Integra(R) Allograft Wedge System for Extremity Reconstruction

Integra LifeSciences recently announced the launch of the Integra Allograft Wedge System, their pre-cut allograft wedges for Evans and Cotton osteotomies. Osteotomies are procedures in which bone is cut and then re-aligned, often with new bone placed as a wedge to secure the new position. The Cotton osteotomy involves the medial cuneiform and is used to correct rotational deformities of the forefoot. The Evans osteotomy, on the other hand, is a lengthening procedure for the calcaneus (heel bone) used most commonly for treating flatfeet. Both osteotomies involve placing a wedge of bone that is often harvested from the patient (autograft). While autograft provides superior structural and healing qualities to donated bone (allograft), harvesting it can cause significant pain and lengthen patient recovery.Integra-Allograft-Wedge-System

Integra’s new Allograft Wedge System has pre-cut wedges in four sizes: 6, 8, 10 and 12mm. This theoretically should allow for more efficient procedures by bypassing some of the measuring and shaping of the graft material that needs to take place.

More from the press release:

Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of Integra(R) Allograft Wedge System, which consists of simple pre-cut allograft wedges for both Evans and Cotton osteotomies and a dedicated instrumentation set that is designed to provide a method of assessing osteotomy space to aid in the selection of the appropriate Integra(R) Allograft Wedge implant.

The Integra(R) Allograft Wedge is processed from human cancellous bone, sterilized through the BioCleanse(R) Tissue Sterilization Process and terminally sterilized using a validated method to achieve a Sterility Assurance Level (SAL) of 10-6. The wedge provides a natural scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. It also eliminates significant harvest site morbidity that may result from autograft removal. Integra will feature the implant at the American Academy of Orthopaedic Surgeons Annual Meeting, February 7-11, 2012 in San Francisco, California.

“Integra(R) Allograft Wedge System offers four sizes (6, 8, 10 and 12mm), which gives surgeons a significant addition to their treatment options and helps limit uncertainty by accommodating a patient’s unique surgical needs,” said Bill Weber, Vice President and General Manager, Integra Extremity Reconstruction.

PLAINSBORO, N.J., Feb. 8, 2012 (GLOBE NEWSWIRE) – Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of Integra® Allograft Wedge System, which consists of simple pre-cut allograft wedges for both Evans and Cotton osteotomies and a dedicated instrumentation set that is designed to provide a method of assessing osteotomy space to aid in the selection of the appropriate Integra® Allograft Wedge implant.

Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Integra® Allograft Wedge is designed to provide bone grafting material for osteotomy corrections. The Integra® Allograft Wedge is processed from human cancellous bone, sterilized through the BioCleanse® Tissue Sterilization Process and terminally sterilized using a validated method to achieve a Sterility Assurance Level (SAL) of 10-6. The wedge provides a natural scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. It also eliminates significant harvest site morbidity that may result from autograft removal. Integra will feature the implant at the American Academy of Orthopaedic Surgeons Annual Meeting, February 7-11, 2012 in San Francisco, California.

“Integra® Allograft Wedge System offers four sizes (6, 8, 10 and 12mm), which gives surgeons a significant addition to their treatment options and helps limit uncertainty by accommodating a patient’s unique surgical needs,” said Bill Weber, Vice President and General Manager, Integra Extremity Reconstruction.

The Integra® Allograft Wedge System is distributed through Integra’s Extremity Reconstruction sales organization, which focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.

Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care.  Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery. For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results.  Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2010 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Source:http://investor.integralife.com/releasedetail.cfm?ReleaseID=647134&keepThis=true&TB_iframe=true&height=550&width=790

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CT System Receives FDA Clearance

CT System Receives FDA Clearance

Toshiba has received FDA clearance for their Aquilion PRIME CT system. The scanner uses many of the features developed for the Aquilion ONE, and focuses on low radiation dose and a fast workflow.

Compared to the Aquilion ONE it has fewer detector rows (80 vs. 320) and a shorter coverage area, but it does add two more clinical applications: dual energy scanning and lung volume measurement (both optional packages). From the press release:

With double-slice technology and coneXactTM reconstruction algorithm, originally designed for Aquilion ONE, the system can generate 160 unique slices per rotation, enhancing MPR and 3D-rendered images. The Aquilion PRIME was designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations and produce high-quality clinical images with reduced radiation exposure.

The Aquilion PRIME features an 80-row, 0.5 mm detector, a 7.5 MHU large-capacity tube, and 0.35-second scanning. This high-speed rotation allows rapid data acquisition and shortens scan times while the fast reconstruction unit further improves throughput, reducing time required for diagnosis. The system also features a 78 cm aperture gantry, the largest currently available in a high-end CT system. The combination of a 660-pound patient-weight-capacity couch with a large gantry bore makes the Aquilion PRIME an ideal system for use in emergency scanning or bariatric patient studies.

To reinforce the principle of As Low As Reasonably Achievable (ALARA) imaging, Adaptive Iterative Dose Reduction (AIDR) and NEMA XR 25 Dose Check Software are standard features on the Aquilion PRIME. AIDR technology is an iterative process that removes noise from the image with reduced radiation dose. Toshiba’s NEMA XR 25 Dose Check Software enhances user awareness of the radiation dose being administered to patients. This software includes Dose Alert and Dose Notification, addressing the two main components of MITA’s CT Dose Check Initiative, as well as Tracking and Digital Imaging and Communications in Medicine (DICOM), to further enhance dose awareness.

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Kaiser Permanente Health Records Securely Available on Mobile Devices

Kaiser Permanente Health Records Securely Available on Mobile Devices

Kaiser Permanente, the largest managed care organization in the United States, has unveiled an Android app and mobile-optimized website through which its 9 million patients can access their own medical information anywhere in the world on their mobile devices. The app and mobile website contain the same information and possibilities that were already available through kp.org, i.e. lab results, diagnostic information, secure email access to doctors, ordering of prescription refills, scheduling appointments and locating of healthcare facilities. It is also possible for family members to get access on behalf of a patient and accomplish the same tasks.

The Android app is available for free from the Android market.

Kaiser Permanente already has the largest electronic medical record system in the world. Today, the health care organization announced that 9 million Kaiser Permanente patients now can easily access their own medical information anywhere in the world on mobile devices through a mobile-optimized website.

Kaiser Permanente has released a new app for Android devices, and users of other mobile devices, including the iPhone, can also get full access to that information from the Kaiser Permanente health record system with the mobile-optimized version of kp.org. An additional app for iPhone will be released in the coming months, but iPhone users can easily download a shortcut icon onto their home screens that will take them directly to the mobile-friendly kp.org with a touch of the finger.

Kaiser Permanente has led the health care world in providing online access to information for its patients. In 2011 alone, more than 68 million lab test results were made available online to Kaiser Permanente patients. The mobile-optimized site and the new app make that information, and much more, securely available at members’ fingertips.

Kaiser Permanente patients will have 24/7 access to lab results, diagnostic information, direct and secure email access to their doctors, and will also be able to order prescription refills. Kaiser Permanente patients have been able to email their doctors for five years, with more than 12 million e-visits in 2011 alone. Kaiser Permanente expects that number to increase significantly with the new app and mobile-optimized site.

The Android app is available now in the Android Market at no charge. Users of other mobile devices can access the same set of care-support tools at no charge through the new secure, mobile-optimized member website, which is available through smart-phone Internet browsers.

With the new offering, Kaiser Permanente patients have 24/7 access from their mobile devices to view their secure personal health record, email their doctors, schedule appointments, refill prescriptions and locate Kaiser Permanente medical facilities. Members who have the ability to act on behalf of a family member on kp.org now can accomplish the same tasks. Those caring for an elderly parent or someone with a chronic condition can now more easily check lab results, refill prescriptions and communicate with the doctor’s office on behalf of the patient.

“This is the future of health care. Health care needs to be connected to be all that it can be. This new level of connectivity is happening real time, and it is happening on a larger scale than anything like it in the world,” said George Halvorson, chairman and chief executive officer of Kaiser Permanente. “The fact that a Kaiser Permanente patient in an emergency room in Paris or Tokyo can simply pull out their mobile device and have immediate and current access to their own medical information is an evolutionary and revolutionary breakthrough for medical connectivity.”

“Our members love our current connectivity tools,” said Christine Paige, senior vice president of marketing and Internet services. “Now we will extend our entire connectivity tool kit for patients through a mobile phone. Our mobile-optimized site and app take connectivity to the next level by making the mobile experience easy and enjoyable. We believe that convenience, paired with a great user experience, will meet members’ needs and will ultimately result in improved health and patient-physician relationships.”

Members using the Android app have access to their kp.org accounts by touching the app icon on their phones. Those visiting kp.org from a mobile phone Internet browser are seamlessly redirected to the mobile-optimized website, which was designed for optimal viewing on a mobile-phone screen. In both cases, a streamlined menu of mobile-optimized features helps members find what they need quickly and easily with minimal taps.

“Providing our patients with clear and convenient access to their health information is a step forward in connectivity and improving the health care experience for patients, no matter where they are,” said Jack Cochran, MD, executive director of The Permanente Federation. “We already have complete connectivity among Kaiser Permanente care sites through Kaiser Permanente HealthConnect®. This new level of connectivity extends the reach of information to our patients in a more convenient and user-friendly format. This new app and mobile-optimized site is very good for patient care and will revolutionize connectivity by bringing health care for the first time to the level of connectivity other parts of our economy have achieved.”

Users’ personal health information is safe and secure while using the new app and the mobile-friendly kp.org, which employ the same security safeguards that protect patient information on the traditional kp.org website, including secure sign-on and automatic sign-out after a period of inactivity.

“The benefits of mobile extend beyond member engagement,” said Philip Fasano, executive vice president and chief information officer of Kaiser Permanente. “Mobile solutions can have a positive impact on health. Health care, itself, will be much more convenient for many people. The mobile-friendly site and app are also a springboard for new innovations that will inspire members to be aware of their health and take steps to improve it.”

The Pew Internet Project reported that 40 percent of American adults access the Internet via their mobile phones, and in some cases, mobile phones are their primary source of Internet access. Twenty-five percent of smart-phone owners go online primarily using their phone; of these, roughly one-third have no high-speed home broadband connection.

“There has been an explosion in the growth of mobile devices and users are looking for new and improved ways to manage their lives online,” Halvorson said. “It is time to make health information easily accessible from mobile devices.”

Edelman’s 2011 Health Barometer reported that 68 percent of those who use digital tools to manage or track their health believed it helped them improve their health,” Paige said. “Nearly 80 percent of kp.org users agreed that the website helps them stay healthy. The tools and services available on kp.org are even more powerful in the palm of your hand.”

This is a major new connectivity offering, but it is not Kaiser Permanente’s first mobile app. Other, more targeted tools, were released earlier. Kaiser Permanente launched its first mobile application, KP Locator for iPhone, in July 2011. The facility-finder app has been downloaded 42,000 times. KP Locator combines the power of kp.org’s robust facility directory and the iPhone’s GPS capabilities to make searching for Kaiser Permanente facilities fast and easy for patients on the go. It answers three of the most basic, but vital, user questions thoroughly and simply — where are the Kaiser Permanente locations close to me, how can I contact and get to them, and what departments and services can I access there? Kaiser Permanente also released itsEvery Body Walk! app two months ago to help encourage people to walk and maintain healthy activity levels, and that app was rated No. 5 in the Top 100 Green Apps by Eco-Libris.

Kaiser Permanente is known for its leadership in the use of health information technology. The Kaiser Permanente electronic health record is the largest non-governmental medical record system in the world. KP HealthConnect enables all of Kaiser Permanente’s nearly 16,000 physicians to electronically access the medical records of all 8.9 million Kaiser Permanente members nationwide and serves as a model for other care systems. Kaiser Permanente has received numerous awards for its health IT expertise, including four 2011 eHealthcare Leadership Awards. You can learn more about how patients, clinicians and researchers are using My Health Manager and KP HealthConnect by checking out Kaiser Permanente’s YouTube channel: www.youtube.com/kaiserpermanenteorg. Kaiser Permanente also has what might be the world’s most complete electronic medical library to support its caregivers by providing convenient access to the best and most current medical science. That electronic medical library is for internal use only.

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Making The Spinal Cord Transparent

Making The Spinal Cord Transparent

Studying the growth of nerve cells is a difficult proposition because one has to isolate them from surrounding tissue and then analyze the very fine slices under the microscope. This process can be time consuming and prone to mistakes and errors.

An international team of researchers headed by neurobiologists at Max-Planck-Institut für Neurobiologie have developed a method of making the spinal cord transparent so that slicing and their 3D reconstruction is not necessary.

Spinal cord tissue is opaque due to the fact that the water and the proteins contained in it refract light differently. Thus, the scientists removed the water from a piece of tissue and replaced it by an emulsion that refracts light in exactly the same way as the proteins. This left them with a completely transparent piece of tissue. “It’s the same effect as if you were to spread honey onto textured glass”, Ali Ertürk, the study’s first author adds. The opaque pane becomes crystal clear as soon as the honey has compensated for the surface irregularities. The new method is a leap forward in regeneration research. By using fluorescent dyes to stain individual nerve cells, scientists can now trace their path from all angels in an otherwise transparent spinal cord section. This enables them to ascertain once and for all whether or not these nerve cells recommenced their growth following injury to the spine – an essential prerequisite for future research.

The spinal cord is the most important pathway for relaying information from the skin, muscles and joints to the brain and back again. Damage to nerve cells in this region usually results in irreversible paralysis and loss of sensation. For many years, scientists have been doing their best to ascertain why nerve cells refuse to regenerate. They search for ways to stimulate these cells to resume their growth.

To establish whether a single cell is growing, the cell must be visible in the first place. Up to now, the procedure has been to cut the area of the spinal cord required for examination into ultra-thin slices. These are then examined under a microscope and the position and pathway of each cell is reconstructed. In exceptional cases, scientists could go to the trouble of first digitizing each slice and then reassembling the images, one by one, to produce a virtual 3D model. However, this is a very time-consuming endeavour, requiring days and sometimes even weeks to process the results of just one examination. Even worse, mistakes can easily creep in and falsify the results: The appendages of individual nerve cells might get squashed during the process of slicing, and the layers might be ever so slightly misaligned when set on top of each other. As Frank Bradke explains: “Although this might not seem dramatic to begin with it prevents us from establishing the length and extent of growth of single cells.” Bradke and his team at the Max Planck Institute of Neurobiology have investigated the regeneration of nerve cells following injuries to the spinal cord. Since July he has been working at the German Centre for Neurodegenerative Diseases (DZNE) in Bonn. “However, since changes on this crucial scale are precisely what we need to see, we worked meticulously until we came up with a better technique”, he continues.

The new technique is based on a method known as ultramicroscopy, which was developed by Hans Ulrich Dodt from the Technical University of Vienna. The Max Planck neurobiologists and an international team of colleagues have now taken this technique a step further. The principle is relatively straightforward. Spinal cord tissue is opaque due to the fact that the water and the proteins contained in it refract light differently. Thus, the scientists removed the water from a piece of tissue and replaced it by an emulsion that refracts light in exactly the same way as the proteins. This left them with a completely transparent piece of tissue. “It’s the same effect as if you were to spread honey onto textured glass”, Ali Ertürk, the study’s first author adds. The opaque pane becomes crystal clear as soon as the honey has compensated for the surface irregularities.

The new method is a leap forward in regeneration research. By using fluorescent dyes to stain individual nerve cells, scientists can now trace their path from all angels in an otherwise transparent spinal cord section. This enables them to ascertain once and for all whether or not these nerve cells recommenced their growth following injury to the spine – an essential prerequisite for future research. “The really great thing is the fact that this method can also be easily applied to other kinds of tissue”, Frank Bradke relates. For example, the blood capillary system or the way a tumour is embedded in tissue could be portrayed and analysed in 3D.

Source:http://www.mpg.de/4737858/spinal_cord_transparent

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Hips that Function Better and Last Longer

Hips that Function Better and Last Longer

Hip replacement surgery has become a common procedure for people in advanced stages of arthritis, but the implants that are used continue to suffer from relatively short lifetimes that often lead to further surgeries. A central mystery of their failure has been the nature of the lubricating layer that forms on both the ball and socket of the joint. Metal-on-metal implants have demonstrated lower wear than metal-on-polymer devices and can be made with larger femoral heads to prevent dislocations, but the reason for the extended lifetime has not been clear.metal hip implant x-ray

Now researchers at Northwestern University, Rush University Medical Center, Chicago, and the University of Duisburg-Essen Germany have reported in the journalScience that, unlike previously thought, graphitic carbon seems to be a key ingredient in the lubricating layer that forms around the implants.  This surprising discovery should help implant designers develop longer lasting devices that take advantage of the graphitic carbon lubricant.

Earlier research by team members Alfons Fischer at the University of Duisburg-Essen and Markus Wimmer at Rush University Medical Center discovered that a lubricating layer forms on metallic joints as a result of friction. Once formed, the layer reduces friction as well as wear and corrosion. This layer is called a tribological layer and is where the sliding takes place, much like how an ice skate slides not on the ice but on a thin layer of water.

But, until now, researchers did not know what the layer was. (It forms on the surfaces of both the ball and the socket.) It had been assumed that the layer was made of proteins or something similar in the body that got into the joint and adhered to the implant’s surfaces.

The interdisciplinary team studied seven implants that were retrieved from patients for a variety of reasons. The researchers used a number of analytical tools, including electron and optical microscopies, to study the tribological layer that formed on the metal parts. (An electron microscope uses electrons instead of light to image materials.)

The electron-energy loss spectra, a method of examining how the atoms are bonded, showed a well-known fingerprint of graphitic carbon. This, together with other evidence, led the researchers to conclude that the layer actually consists primarily of graphitic carbon, a well-established solid lubricant, not the proteins of natural joints.

EVANSTON, Ill. — A team of engineers and physicians have made a surprising discovery that offers a target for designing new materials for hip implants that are less susceptible to the joint’s normal wear and tear.

Researchers from Northwestern University, Rush University Medical Center, Chicago, and the University of Duisburg-Essen Germany found that graphitic carbon is a key element in a lubricating layer that forms on metal-on-metal hip implants. The lubricant is more similar to the lubrication of a combustion engine than that of a natural joint.

The study will be published Dec. 23 by the journal Science.

Prosthetic materials for hips, which include metals, polymers and ceramics, have a lifetime typically exceeding 10 years. However, beyond 10 years the failure rate generally increases, particularly in young, active individuals. Physicians would love to see that lifespan increased to 30 to 50 years. Ideally, artificial hips should last the patient’s lifetime.

“Metal-on-metal implants can vastly improve people’s lives, but it’s an imperfect technology,” said Laurence D. Marks, a co-author on the paper who led the experimental effort at Northwestern. “Now that we are starting to understand how lubrication of these implants works in the body, we have a target for how to make the devices better.”

Marks is a professor of materials science and engineering at Northwestern’sMcCormick School of Engineering and Applied Science.

The ability to extend the life of implants would have enormous benefits, in terms of both cost and quality of life. More than 450,000 Americans, most with severe arthritis, undergo hip replacement each year, and the numbers are growing. Many more thousands delay the life-changing surgery until they are older, because of the limitations of current implants.

“Hip replacement surgery is the greatest advancement in the treatment of end-stage arthritis in the last century,” said co-author and principal investigator Dr. Joshua J. Jacobs, the William A. Hark, M.D./Susanne G. Swift Professor of Orthopedic Surgery and professor and chair of the department of orthopedic surgery at Rush. “By the time patients get to me, most of them are disabled. Life is unpleasant. They have trouble working, playing with their grandchildren or walking down the street. Our findings will help push the field forward by providing a target to improve the performance of hip replacements. That’s very exciting to me.”

Earlier research by team members Alfons Fischer at the University of Duisburg-Essen and Markus Wimmer at Rush University Medical Center discovered that a lubricating layer forms on metallic joints as a result of friction. Once formed, the layer reduces friction as well as wear and corrosion. This layer is called a tribological layer and is where the sliding takes place, much like how an ice skate slides not on the ice but on a thin layer of water.

But, until now, researchers did not know what the layer was. (It forms on the surfaces of both the ball and the socket.) It had been assumed that the layer was made of proteins or something similar in the body that got into the joint and adhered to the implant’s surfaces.

The interdisciplinary team studied seven implants that were retrieved from patients for a variety of reasons. The researchers used a number of analytical tools, including electron and optical microscopies, to study the tribological layer that formed on the metal parts. (An electron microscope uses electrons instead of light to image materials.)

The electron-energy loss spectra, a method of examining how the atoms are bonded, showed a well-known fingerprint of graphitic carbon. This, together with other evidence, led the researchers to conclude that the layer actually consists primarily of graphitic carbon, a well-established solid lubricant, not the proteins of natural joints.

“This was quite a surprise,” Marks said, “but the moment we realized what we had, all of a sudden many things started to make sense.”

Metal-on-metal implants have advantages over other types of implants, Jacobs said. They are a lower wear alternative to metal-on-polymer devices, and they allow for larger femoral heads, which can reduce the risk of hip dislocation (one of the more common reasons for additional surgery). Metal-on-metal also is the only current option for a hip resurfacing procedure, a bone-conserving surgical alternative to total hip replacement.

“Knowing that the structure is graphitic carbon really opens up the possibility that we may be able to manipulate the system in a way to produce graphitic surfaces,” Fischer said. “We now have a target for how we can improve the performance of these devices.”

“Nowadays we can design new alloys to go in racing cars, so we should be able to design new materials for implants that go into human beings,” Marks added.

The next phase, Jacobs said, is to examine the surfaces of retrieved devices and correlate the researchers’ observations of the graphitic layer with the reason for removal and the overall performance of the metal surfaces. Marks also hopes to learn how graphitic debris from the implant might affect surrounding cells.

Source:http://www.northwestern.edu/newscenter/stories/2011/12/hip-replacements-metal.html

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Team designs a bandage that spurs, guides blood vessel growth

Team designs a bandage that spurs, guides blood vessel growth

Researchers at University of Illinois Urbana–Champaign developed an amazing little bandage, which they call a “microvascular stamp”, that promotes angiogenesis while guiding exactly where the vessels should go.

It is imbued with living cells, positioned in a defined pattern, that release growth factors around a wound and cause vessels to grow where intended.  The study will be appearing in next month’s issue of Advanced Materials.

The stamp is nearly 1 centimeter across and is built of layers of a hydrogel made of polyethylene glycol (an FDA-approved polymer used in laxatives and pharmaceuticals) and methacrylic alginate (an edible, Jell-O-like material).

The stamp is porous, allowing small molecules to leak through, and contains channels of various sizes to direct the flow of larger molecules, such as growth factors.

The researchers tested the stamp on the surface of a chicken embryo. After a week the stamp was removed, revealing a network of new blood vessels that mirrored the pattern of the channels in the stamp.

The researchers see many potential applications for the new stamp, from directing the growth of blood vessels around a blocked artery, to increasing the vascularization of tissues with poor blood flow, to “normalizing” blood vessels that feed a tumor to improve the delivery of anti-cancer drugs. Enhancing the growth of new blood vessels in a coordinated pattern after surgery may also reduce recovery time and lessen the amount of scar tissue, the researchers said.

A paper describing the new approach will appear as the January 2012 cover article of the journal Advanced Materials.

“Any kind of tissue you want to rebuild, including bone, muscle or skin, is highly vascularized,” said University of Illinois chemical and biomolecular engineering professor Hyunjoon Kong, a co-principal investigator on the study with electrical and computer engineeringprofessor Rashid Bashir. “But one of the big challenges in recreating vascular networks is how we can control the growth and spacing of new blood vessels.”

“The ability to pattern functional blood vessels at this scale in living tissue has not been demonstrated before,” Bashir said. “We can now write features in blood vessels.”

Other laboratories have embedded growth factors in materials applied to wounds in an effort to direct blood vessel growth. The new approach is the first to incorporate live cells in a stamp. These cells release growth factors in a more sustained, targeted manner than other methods, Kong said.

The stamp is nearly 1 centimeter across and is built of layers of a hydrogel made of polyethylene glycol (an FDA-approved polymer used in laxatives and pharmaceuticals) and methacrylic alginate (an edible, Jell-O-like material).

The stamp is porous, allowing small molecules to leak through, and contains channels of various sizes to direct the flow of larger molecules, such as growth factors.

The researchers tested the stamp on the surface of a chicken embryo. After a week the stamp was removed, revealing a network of new blood vessels that mirrored the pattern of the channels in the stamp.

“This is a first demonstration that the blood vessels are controlled by the biomaterials,” Kong said.

The researchers see many potential applications for the new stamp, from directing the growth of blood vessels around a blocked artery, to increasing the vascularization of tissues with poor blood flow, to “normalizing” blood vessels that feed a tumor to improve the delivery of anti-cancer drugs. Enhancing the growth of new blood vessels in a coordinated pattern after surgery may also reduce recovery time and lessen the amount of scar tissue, the researchers said.

In another study published earlier this year, the team developed a biodegradable material that supports living cells. Future research will test whether the new material also can be used a stamp.

Researchers on the study team also included K. Jimmy Hsia, a professor of mechanical science and engineering and of bioengineering at Illinois; postdoctoral researchers Jae Hyun Jeong and Pinar Zorlutuna; and graduate students Vincent Chan, Chaenyung Cha and Casey Dyck.

This study was supported in part by the National Science Foundation Emergent Behaviors of Integrated Cellular Systems Center at Illinois, Georgia Institute of Technology and Massachusetts Institute of Technology; the U.S. Army Telemedicine & Advanced Technology Research Center; an NSF Career grant; the American Heart Association; and the Amore Pacific Corp.

Bashir, the Abel Bliss Professor of Engineering, also is a professor of bioengineering. He and Kong are affiliates of the Micro and Nanotechnology Lab and the Institute for Genomic Biology at Illinois.

Source:http://news.illinois.edu/news/11/1215blood_HyunjoonKong_RashidBashir.html

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Ways To Test Medical Procedures

Ways To Test Medical Procedures

The Wall Street Journal is profiling researchers at Rensselaer Polytechnic Institute and the FDA who are building virtual computer patients to study things like how far X-ray radiation penetrates obese patients, where to place implants in children, and how best to spot vascular occlusions.  By studying the human body and encoding the many variables into a computer simulation, studies that would otherwise be dangerous to perform on live subjects can be done on the computer.CT scan.

Virtual patients could allow medical-device companies to test new products earlier, helping the devices get to market more quickly and cheaply, according to the Food and Drug Administration.

Virtual technology also someday could provide opportunities for doctors and medical students to train for certain surgical procedures by seeing and feeling organs virtually while using real tools. Doctors could be able to calculate the probability of a pregnant woman having a high-risk delivery, based on synthesized, three-dimensional images of the pelvic region and fetus, researchers say.

X. George Xu leads a team of nuclear engineers at Rensselaer Polytechnic Institute in Troy, N.Y., studying how radiation interacts with the human body. Computerized tomography, or CT, scans are frequently used in medicine to image tissues and bones in the body. But repeated exposure to radiation from the scans is believed to raise the risk for cell damage that may cause cancer and other health problems. Such risks also can exist for patients receiving radiation to treat tumors.

The researchers recently created an obese virtual patient to demonstrate what happens to radiation in this body type. Because fat can disperse the waves, overweight people usually need a higher dose of radiation in medical procedures. The aim is to administer sufficient radiation to achieve an image scan of adequate quality, but not too much to cause harm to the patient. Currently, some doctors may use existing computer software to estimate how much additional radiation is required based on factors such as weight, height and age of the patient.

Dr. Xu’s team showed that the virtual patient, using more sophisticated modeling such as how fat is distributed in the body, can provide more accurate calculations of how much additional radiation an overweight person requires. The work was presented early this year at a conference of the American Nuclear Society and has been submitted for publication at a peer-reviewed journal, according to Dr. Xu.

In related work, supported by a $1.2 million government grant, researchers developed computer software that provides readings about how much radiation each organ of the body receives after radiation exposure from a medical procedure, says Aiping Ding, a Rensselaer Polytechnic research associate who is spearheading the project.

The researchers recently tested the new software, called VirtualDose, in a simulation of an abdominal CT scan of a woman in her sixth month of pregnancy. They found that although the fetus did absorb radiation, the dose was 40% less than that calculated by a more rudimentary software tool that is currently in use.

The team hopes that calculations from virtual patients will help guide doctors in targeting tumors or making clinical decisions, like figuring out if the benefits to the mother in getting a CT scan outweigh the risks to the fetus.

Dr. Xu began decades ago creating models of human patients to understand how radiation affects the body. His first-generation designs were models that could be touched and felt. They were built of substances meant to mimic biological materials and had radiation sensors embedded throughout the torso.

Karl, a faceless, putty-colored model Dr. Xu created 20 years ago, still sits on a desk in his lab. It contrasts sharply with the strikingly vivid and anatomically correct virtual patients on the computer screen nearby.

Additional work is being done at the Center for Devices and Radiological Health, part of the FDA. Researchers there have created a “virtual family” of adults and children in order to study how best to implant medical devices in children, such as heart defibrillators. Defibrillators have been mainly studied for adult use, although children’s heart anatomy is different from that of adults.

The FDA also is exploring improved diagnostic techniques using virtual patients. In a virtual catheterization lab, scientists are inserting virtual blockages in blood flow into the heart. They then run a series of scans aimed at determining which images best detect the locations and size of the blockages. The research mimics a clinical trial, but can be performed more quickly and without risk to real patients, says Kyle Myers, director of the Division of Imaging and Applied Mathematics at the FDA division. She says researchers hope in the future to use the techniques to investigate potential treatments.

Source:http://online.wsj.com/article/SB10001424052970204058404577108602870031954.html?mod=dist_smartbrief,http://medgadget.com/

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Harnessing the Power of Data

Harnessing the Power of Data

Health IT is a big deal these days. While there has been some controversy surrounding it, there is no doubt that, if implemented well, it can improve everything from disease monitoring to noncompliance with doctors’ orders. Such transformation seems inevitable because of IT’s ability to transform other aspects of our lives. Within the last 20 years, for instance, information technology has vastly simplified banking, performing research, and making travel arrangements. But, as people such as Mark Smith, president and CEO of the California HealthCare Foundation have pointed out, healthcare has lagged far behind other industries in its implementation of IT.Healthcare Delivery

To get a better sense of what its role in healthcare will be in the near future, Medgadget had the opportunity to interview Eric Marx, Vice President of Healthcare IT Services at Modis—an IT staffing agency.

Medgadget: One of the most important issues in healthcare these days is cost control. How can health IT data help control costs? In addition, how can health IT transform healthcare delivery and epidemiology?

Marx: The largest cost savings over the long run should come through the collection and comparison of large volumes of national patient and treatment data, using business intelligence (BI) to compare the lowest patient treatment costs with similar outcomes. For example, if it is found that a relatively inexpensive drug delivers similar results to more expensive surgery, and that can be replicated across the entire country, that should shift costs down over time, or at least reduce the growth rate of costs.

Additionally, as our BI and predictive analytics knowledge matures, the goal would be to spot trends in the data that can help us prevent and contain things like disease outbreaks. Catching issues early could have a huge impact on the population.

Medgadget: What kind of influence do you think cloud computing will play in all of this?

Marx: Cloud computing makes a lot of sense for two reasons. One, it has been proven to significantly reduce infrastructure costs. Second, it may be more efficient if changes can be managed centrally and pushed out more rapidly and consistently to adjust to ever changing federal regulations.

Medgadget: What is being done about privacy concerns related to health data?

Marx: HIPAA laws and the Privacy Rule are in place to cover this, and this is a focus area that likely will have greater scrutiny from HHS, with likely more teeth in it than in the past, such as more high-profile sanctions and penalties. With the significant healthcare IT expansion and sharing of data, there is a lot of discussion addressing who owns patient data at which point during the exchange of data amongst healthcare stakeholders, determining who is ultimately responsible and liable at various transaction points.

Medgadget: What is the healthcare industry now doing to prepare for the International Classification of Diseases (ICD-10 is the latest version) from the World Health Organization?

Marx: Most healthcare industry organizations seem to be on track to meet the HIPAA 5010 upgrade requirement by January 1, as a prerequisite on the path to full ICD-10 compliance by October 1, 2013. Most organizations seem to at least have a strategic plan in place, or are working on that, but we expect by late 2012 many places will be struggling to meet project milestones based on complexity and scarcity of qualified resources.

Medgadget: What, in your view, are the employment opportunities likely to be in electronic medical records (EMR), both in the short and long term?

Marx: Short term, the market is very hot for those with experience in the major EMR vendors like Epic, Cerner, MEDITECH, and Allscripts. A lot of formerly full-time employees are entering the lucrative contracting market, so over time, the market should balance out a bit more. Long term, we would expect folks with expertise in security, BI/DW, report writing, and business analysis skills with backgrounds in the healthcare industry to be in high demand.

Source:http://medgadget.com/2011/12/predicting-the-future-of-health-it-how-it-could-curb-medical-costs-and-transform-healthcare-delivery.html

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Proxima Generation 2 Achieves European CE Marking

Proxima Generation 2 Achieves European CE Marking

Sphere Medical based in Cambridge, UK received the European CE Mark of approval for its Proxima Generation 2 disposable arterial blood analyser. The device is intended for continuous monitoring of glucose, blood gas & electrolytes in patients in the OR and ICU and a recent clinical study has shown that the Proxima Generation 2 provides an equivalent performance when compared to lab and point-of-care blood gas analysers of arterial blood.proxima-generation

Because measurements are made on a continuous basis and all the blood is immediately returned to the patient, the device lets clinicians keep a steady eye on patients without having to take regular readings and run samples to the lab.

Cambridge, UK, 19 December 2011: Sphere Medical Holding plc (AIM:SPHR.L) (“Sphere Medical” or the “Company”), a leading developer of  innovative monitoring and diagnostic products for the critical care setting, is pleased to announce that Proxima Generation 2 has achieved European CE Marking as an in-vitro diagnostic device. Proxima Generation 2 is Sphere Medical’s disposable patient-attached arterial blood analyzer.
The CE Marking of Proxima Generation 2 follows the announcement on 21 November that the clinical trial on Proxima Generation 2 had met its primary endpoint to demonstrate equivalent performance to laboratory and Point of Care blood gas analysers measuring arterial blood in a clinical setting.
The Company now intends to initiate a number of marketing studies in leading UK hospitals which will utilise the CE Marked Proxima device to build up substantial feedback on clinical use. Commenting on the Proxima Generation 2 CE Marking,  Chief Executive Officer, Dr Stuart Hendry, said: “The achieving of CE Marking for Proxima Generation 2 is a major milestone achievement for Sphere Medical and sets the foundations for the commercialisation of our
lead product.”

Cambridge, UK, 19 December 2011: Sphere Medical Holding plc (AIM:SPHR.L) (“Sphere Medical” or the “Company”), a leading developer of  innovative monitoring and diagnostic products for the critical care setting, is pleased to announce that Proxima Generation 2 has achieved European CE Marking as an in-vitro diagnostic device. Proxima Generation 2 is Sphere Medical’s disposable patient-attached arterial blood analyser. The CE Marking of Proxima Generation 2 follows the announcement on 21 November that the clinical trial on Proxima Generation 2 had met its primary endpoint to demonstrate equivalent performance to laboratory and Point of Care blood gas analysers measuring arterial blood in a clinical setting. The Company now intends to initiate a number of marketing studies in leading UK hospitals which will utilise the CE Marked Proxima device to build up substantial feedback on clinical use.   Commenting on the Proxima Generation 2 CE Marking,  Chief Executive Officer, Dr Stuart Hendry, said: “The achieving of CE Marking for Proxima Generation 2 is a major milestone achievement for Sphere Medical and sets the foundations for the commercialisation of our lead product.”

Sphere Medical commenced trading on the AIM, a market operated by the London Stock  Exchange (LSE) on 17 November 2011 having raised £14m (£12.8m net of expenses) in a  placing of ordinary shares.  Sphere Medical is a UK based medical device company completing the development of a  range of monitoring and diagnostic products designed to provide significant improvements in  patient management in a number of hospital specialities. Sphere Medical’s products are expected to allow near real time measurement of blood gases, various electrolytes and drug levels with laboratory accuracy, at the patient’s bedside. This information can be used in a wide range of medical applications and is intended to enable faster clinical decision making and consequently to improve the management of patients. Sphere Medical’s two most advanced products, based  on its proprietary micro analyser Intensive Care Unit and Operating Room (‘Proxima’)  and a device for continuous blood monitoring in the bypass circuit in patients undergoing cardiopulmonary bypass surgery (“CPB device”). Sphere Medical has also developed and is selling a device (‘Pelorus 1000’) that can measure blood levels of the intravenously administered anaesthetic drug, propofol. In each case, these products will ultimately target patients requiring close monitoring and frequent levels of blood testing. Sphere Medical employs approximately 45 staff in the areas of research and development, product development, sales and marketing and management and operations at its premises at Harston, Cambridge, UK. platform technology, are a disposable patient-attached arterial blood analyser for use in the Intensive Care Unit and Operating Room (‘Proxima’)  and a device for continuous blood monitoring in the bypass circuit in patients undergoing cardiopulmonary bypass surgery (“CPB device”). Sphere Medical has also developed and is selling a device (‘Pelorus 1000’) that can measure blood levels of the intravenously administered anaesthetic drug, propofol. In each case, these products will ultimately target patients requiring close monitoring and frequent levels of blood testing. Sphere Medical employs approximately 45 staff in the areas of research and development, product development, sales and marketing and management and operations at its premises at Harston, Cambridge, UK.

Source:http://medgadget.com/2011/12/proxima-generation-2-arterial-blood-analyser-gets-eu-clearance.html,http://www.spheremedical.com/documents/news/Proxima%20Generation%202%20Achieves%20European%20CE%20Marking.pdf

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Philips announces FDA clearance and first commercial installation of its HeartNavigator interventional tool in the United States

Philips announces FDA clearance and first commercial installation of its HeartNavigator interventional tool in the United States

After the recent introduction of transcatheter heart valves in the US, manufacturers are rushing to equip advanced cath labs with tools that will facilitate these complex procedures. Philips today announced FDA clearance of the HeartNavigator, a GPS-like tool that helps interventional cardiologists and cardiac surgeons to navigate during transcatheter aortic valve implantation (TAVI) procedures. It creates a 3D image from previously acquired 2D CT datasets. These 2D datasets are reconstructed and overlaid with live images to provide real-time 3D insights during the procedure. With one click, the heart is automatically segmented to visualize anatomical structures and landmarks. Virtual device templates can then be used to assess and select the appropriate device size and the best projection for the patient’s individual anatomy. The positioning of the catheter can be visualized in real-time together with the placement and deployment of the artificial valve. ‘HeartNavigator’

In Europe the HeartNavigator was already commercially introduced earlier this year. Now the Medical City Dallas Hospital, Dallas, Texas is the first hospital in the U.S. to use the HeartNavigator interventional tool in clinical practice.

Dr. Todd M. Dewey, MD, Cardiothoracic Surgeon at Medical City Dallas Hospital was cited in the Philips press release:

“After the recent commercial introduction of transcatheter heart valves in the U.S., we are now able to offer heart valve implantations to a group of patients for whom the risks associated with open heart surgery are too high. The implantation of a heart valve via a catheter has the advantage of being minimally invasive, but it demands high-quality imaging and precise navigation to ensure accurate positioning. HeartNavigator gives us a much better view of the procedure, which aids us in the preparation of the procedure as well as the execution.”

Andover, Mass. – Royal Philips Electronics (NYSE: PHG, AEX: PHI) today announced that Medical City Dallas Hospital (Dallas, Texas, U.S.) is the first hospital in the U.S. to use Philips’ innovative HeartNavigator interventional tool in clinical practice. HeartNavigator is a new procedure planning and image guidance tool to help interventional cardiologists and cardiac surgeons perform minimally invasive heart valve replacements. Developed in cooperation with partner hospitals around the world, HeartNavigator is designed to increase the objectivity of the procedure planning and to simplify the procedure itself. By doing so, it aims to reduce the burden on patients and improve patient care.

HeartNavigator was commercially introduced in Europe in the first quarter of 2011 and recently received 510(k) clearance from the Food and Drug Administration (FDA). As a pioneer and market leader in interventional cardiology, Philips is one of the first companies to offer a comprehensive portfolio in the U.S. that includes hybrid operating room solutions and imaging solutions plus advanced interventional tools that work smoothly in sync with them.

“After the recent commercial introduction of transcatheter heart valves in the U.S., we are now able to offer heart valve implantations to a group of patients for whom the risks associated with open heart surgery are too high,” said Dr. Todd M. Dewey, MD, Cardiothoracic Surgeon at Medical City Dallas Hospital, Dallas, Texas, U.S. “The implantation of a heart valve via a catheter has the advantage of being minimally invasive, but it demands high-quality imaging and precise navigation to ensure accurate positioning. HeartNavigator gives us a much better view of the procedure, which aids us in the preparation of the procedure as well as the execution.”

In contrast to open heart surgery, which involves significant opening up of the patient’s chest, minimally invasive heart valve replacement only requires a small incision, through which catheters are inserted and guided to the heart with the aid of dedicated interventional X-ray systems. Because the artificial valves required for such procedures were only recently commercially introduced in the U.S., the adoption of minimally invasive heart valve replacement in the U.S. is still in its early stages, but is expected to increase rapidly. In Europe, where such valves have been commercially available since 2008, it is estimated that more than 13,000 minimally invasive valve replacements were performed in 2010 – a number that has been growing at high double-digit growth rates year-on-year.

Dr. H. Schröfel, Senior Cardiac Surgeon at the Karlsruhe Heart Surgery Clinic, Germany, commented: “I plan all my cases with the HeartNavigator. I trust the measurements with HeartNavigator more than the measurements provided by the normal CT scan.” To date a total of 895 transcatheter aortic heart valve replacement procedures have been performed at the Karlsruhe Heart Surgery Clinic.

Because minimally invasive heart valve replacement procedures deprive physicians of the ability to directly see and touch the patient’s heart, they are complex and technically demanding. Philips has developed a new technology that merges pre-operatively acquired 3D CT scans of the patient’s heart with the live interventional X-ray views. Using this technology, physicians can now simultaneously see the detailed 3D anatomy of the patient’s heart together with the positioning of the catheter and the placement and deployment of the artificial valve.

“Over the years, we have introduced innovative solutions that have helped to simplify minimally invasive procedures and improve patient care,” said Bert van Meurs, Senior Vice President and General Manager Interventional X-ray Systems, Philips Healthcare. “We are committed to expanding our offering in new and growing minimally invasive  clinical applications, such as structural heart repair, and to maintaining our leadership position in interventional cardiology through continuous innovation and collaboration.”

Source:http://medgadget.com/2011/12/philips-heartnavigator-system-for-transcatheter-heart-valve-implantation-receives-fda-clearance.html,http://www.newscenter.philips.com/main/standard/news/press/2011/20111221_heartnavigator.wpd

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