June 2008 Archive

Monday, June 30, 2008

BioTime Begins First Complete Database of Human Stem Cell Differentiations

Filed under: Genetics

BioTime Inc of Emeryville, California, a daughter company of Embryome Sciences, has launched an online database that aims to document and map all the different cells that were lab created out of human embryonic stem cells.

From the announcement:

In a paper published today [June 27, 2008] titled "The International Embryome Initiative: A Collaborative Database for Navigating the Complexities of Human Embryonic Stem Cell Differentiation," available online at www.futuremedicine.com/loi/rme, BioTime and Embryome Sciences describe the collaboration to map the "embryome" in a manner similar to the international initiatives to map the human DNA or genome in the 1990s. While the database launched today at Embryome.com is currently populated with nearly 2,000 distinct cell types, the complete map will require the collective efforts of hundreds of scientists over the coming months.
The California Institute for Regenerative Medicine, which is the funding arm of the $3 billion California stem cell initiative, has agreed to be the first subscriber to all features of the database on behalf of all researchers residing within the state of California.

Press release: BioTime, Inc. and Embryome Sciences, Inc. Launch Embryome.com and the International Embryome Initiative ...

Embryome.com...

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Monday, June 30, 2008

G-Wire: Visually Positioned Guidewire for Faster, Safer Procedures

Filed under: Cardiology , Neurological Surgery , Ob/Gyn , Radiology , Surgery , Vascular Surgery

Israel's MediGuide and Japans' Asahi Intecc have announced that the two companies are teaming up to develop a new surgical guide wire that can be visually monitored and controlled in real time using MediGuide's Medical Positioning System (gMPS), a technology previously reported by us as "intrabody positioning system for medical devices, guide-wires, coronary catheterization devices, and such."

From the announcement press release:

This innovative G-Wire™ will enable physicians to visually track the actual orientation as well as the 3D spatial tip position of the wire while manipulating it in real time. In addition, it will enable marking and 3D visualization capabilities also offered by the MediGuide technology. These capabilities are achieved using MediGuide's Medical Positioning System (gMPS™) technology, incorporated within various Cath Labs which has been recently approved for use in Europe. This new functionality is expected to be extremely useful during procedures such as chronic total occlusion (CTO) as well as other complex operations which require accurate wire manipulation in the field of interventional cardiology.
Martin B. Leon, M.D., Professor of Medicine at Columbia University Medical Center and Founder of the Cardiovascular Research Foundation in New York City, said: “This collaboration brings together the most advanced guidewires and sophisticated imaging and guidance technology, providing an exciting opportunity to improve CTO therapy in the future.”

Dr. Osamu Katoh, Director of Research Center at the Toyohashi Heart Center, said
"No matter how you look at it, Asahi's guide wire technology produces one to one torque performance. The integration of Asahi's one to one torque performance technology and MediGuide's gMPS navigation technology, will create a tremendous synergy effect that could dramatically improve the treatment options for complex lesions, including CTO's"

Press release: Asahi Intecc and MediGuide announced collaboration in development and sales of innovative gMPS™ Enabled Guide Wire (G-Wire™) ...

Nerve Cells Made from Stem Cells Successfully Transplanted

Filed under: in the news...

Researchers at the Burnham Institute for Medical Research in La Jolla, CA have for the first time converted stem cells to nerve cells, and implanted them into mice. The transplantation and accommodation of these cells was successful, and the scientists did not get into the common problems associated with transplanted cells, such as resulting formation of tumors.

Prior to this research, creating pure neuronal cells from ES cells had been problematic as the cells did not always differentiate into neurons. Sometimes they became glial cells, which lack many of the neurons’ desirable properties. Even when the neuronal cells were created successfully, they often died in the brain following transplant—a process called programmed cell death or apoptosis. In addition, the cells would sometimes become tumors.
Dr. Lipton solved these problems by inducing ES cells to express a protein, discovered in his laboratory called myocyte enhancer factor 2C (MEF2C). MEF2C is a transcription factor that turns on specific genes which then drive stem cells to become nerve cells. Using MEF2C, the researchers created colonies of pure neuronal progenitor cells, a stage of development that occurs before becoming a nerve cell, with no tumors. These cells were then transplanted into the brain and later became adult nerve cells. MEF2C also protected the cells from apoptosis once inside the brain.

“To move forward with stem cell-based therapies, we need to have a reliable source of nerve cells that can be easily grown, differentiate in the way that we want them to and remain viable after transplantation,” said Dr. Lipton. “MEF2C helps this process first by turning on the genes that, when expressed, make stem cells into nerve cells. It then turns on other genes that keep those new nerve cells from dying. As a result, we were able to produce neuronal progenitor cells that differentiate into a virtually pure population of neurons and survive inside the brain.”

The next step was to determine whether the transplanted neural progenitor cells became nerve cells that integrated into the existing network of nerve cells in the brain. Performing intricate electrical studies, Dr. Lipton’s investigative team showed that the new nerve cells, derived from the stem cells, could send and receive proper electrical signals to the rest of the brain. They then determined if the new cells could provide cognitive benefits to the stroke-afflicted mice. The team executed a battery of neurobehavioral tests and found that the mice that received the transplants showed significant behavioral improvements, although their performance did not reach that of the non-stroke control mice. These results suggest that MEF2C expression in the transplanted cells was a significant factor in reducing the stroke-induced deficits.

Press release: Nerve Cells Derived from Embryonic Stem Cells and Transplanted into Mice May Lead to Improved Brain Treatments ...

Image credit: Wellcome images: Dorsal Root Ganglion neurones in culture...

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Genome Synthesis Technique for Virus Vaccine Development

Filed under: in the news...

A group at Stony Brook University has modified the polio virus to create a weakened version, which, when injected, went on to effectively immunize lab mice. The team of molecular biologists and computer scientists used a novel algorithm to sort through potential recordings of the genome that would produce the desired proteins. The technique may lead to practical, systematic methods of developing future viral vaccines.

Because of the redundancy of the genetic code, there are an unimaginably large number of ways to encode any given protein. For poliovirus proteins, there are more possible encodings (10 to the 442 power) than atoms in the universe. Using a powerful computer algorithm, the team found particular re-codings of the genome predicted to weaken the virus. The researchers made hundreds of small mutations in the genome that perfectly preserved the viral proteins but changed the way those proteins were encoded by RNA (ribonucleic acid), so that pairs of amino acids were added by transfer RNAs (tRNAs) that rarely work together in normal proteins. They call the process “Synthetic Attenuated Virus Engineering,” or “SAVE.” The resulting virus contains completely authentic, wild-type poliovirus proteins. However, each of the hundreds of mutations causes a tiny defect by creating an obstacle – a genetic “speed bump” – in translating the genetic code into a protein.
“Translation of this unusual genome into viral proteins was inefficient, and the most highly re-coded virus was weakened to the point where it was unable to infect cells,” says J. Robert Coleman, Lead Author and a graduate student in Molecular Genetics and Microbiology.

The reduced translational efficiency of these chimeric viruses reduced their ability to cause disease. The team injected mice with the re-coded polioviruses. Most mice showed no signs of disease but did produce anti-polio antibodies. These mice were then immune against infection by the normal, fully virulent poliovirus.

Press release: SBU Team Designs Customized "Wimpy" Polioviruses, A Method That Could Be A New Path To Vaccines ...

Abstract in Science: Virus Attenuation by Genome-Scale Changes in Codon Pair Bias

Image: The structural appearance of Poliovirus (type I, Mahoney strain) coating protein

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Zinc Finger DNA-Binding Protein Technology Gives T-Cells Shield Against HIV

Filed under: Genetics , Medicine

Sangamo BioSciences, Inc., based in Richmond, California, is reporting positive news showing that CD4 T-cells can be made HIV resistant with the help of the company's proprietary zinc finger DNA-binding protein nucleases (ZFN), specially developed transcription factors.

From Sangamo:

Sangamo's ZFNs are designed to permanently modify the DNA sequence encoding CCR5, a co-receptor that enables HIV to enter and infect cells of the immune system. Individuals carrying a naturally occurring mutation of their CCR5 gene, a variant known as CCR5-delta32, have been shown to be resistant to HIV infection.
"The data described in this paper are an important demonstration of the potential therapeutic properties of our product," commented Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer. "We have demonstrated that a single treatment with our CCR5-specific ZFNs generates a population of HIV-resistant human T-cells similar to the situation in individuals carrying the natural CCR5-delta32 mutation. ZFN-modification of these cells is permanent and makes them resistant to HIV. The modified cells preferentially survive and expand in an animal after HIV infection, providing a reservoir of healthy and uninfectable immune cells. Furthermore, we observed that animals given the ZFN-modified cells had increased numbers of CD4 cells and substantially lower levels of HIV in their blood compared to animals given non-modified cells demonstrating statistically significant protection from the virus. In an HIV-infected patient, such modified cells could be available as a protected reservoir within the immune system to fight both opportunistic infections and HIV itself."

Several major pharmaceutical companies have initiated programs to develop small molecule or monoclonal antibody approaches to block the binding of HIV to CCR5. However, a small molecule or antibody approach requires the constant presence of a sufficiently high concentration of these drugs or antibody to block therapeutically relevant numbers of the CCR5 protein, which is present in thousands of copies on the surface of each T-cell and other tissues in the body. One such drug has been approved by the US Food and Drug Administration with a "black box" warning, the strongest for prescription drugs, concerning the risk of liver toxicity and the possibility of heart attacks.

Sangamo's ZFN technology represents a means of potentially circumventing these limitations or risks by specifically modifying only CD4 T-cells, the principal target of HIV pathology, in a one-time exposure of the cells to ZFNs. This results in permanent modification of the CCR5 protein such that HIV cannot enter and infect the cells. This approach could potentially enable the generation of a reservoir of protected CD4 T-cells that are available to fight the opportunistic infections that are characteristic of AIDS as well as HIV itself. Sangamo expects to initiate a clinical trial to evaluate this approach by the end of the year.

Press release: Sangamo BioSciences Announces Nature Biotechnology Study Demonstrating the Use of Zinc Finger Nucleases to Generate HIV Resistant T Cells ...

Sangamo ZFP technology page...

Abstract in Nature: Establishment of HIV-1 resistance in CD4⁺ T cells by genome editing using zinc-finger nucleases

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First System for Treatment of Vertigo Wins Approval

Filed under: Neurology

According to Portland Business Journal, Vesticon Corp. out of Portland, Oregon just received FDA approval for the first device to diagnose and help treat people experiencing benign paroxysmal positional vertigo (BPPV). Here's, in simple terms, how the system works. The Epley Omniax system uses glasses equipped with infrared sensors that track the eye of a patient sitting in a free-rotating chair that performs "canalith repositioning maneuvers". The problem is that in many people loose particles, called otoconia, are found in the semi-circular canals of the inner ear. The movement of otoconia disrupts normal sensing of one's orientation, and the eye involuntarily responds, via reflex called nystagmus, to otoconia's rumbling around the canals. By monitoring the eye one can detect the particles' presence, and also shake them out of the sensitive areas by rotating the patient.

From the product page:

Quantified procedures with recording and report for Dx / Tx for all six canals and all conditions related to BPPV.

Repeatable, comparable, precise maneuvers for definitive patient management.

Facilitates best practices and standardization.

Facilitates detection and treatment to optimize outcomes for even the most difficult cases.

Company video describing the workings of the Omniax system:

More at Portland Business Journal...

Product page: Epley Omniax ...

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Friday, June 27, 2008

Battling Migraines From the Inside and Out

Filed under: Neurological Surgery , Neurology

Two interesting studies are being reported at the ongoing annual scientific meeting of the American Headache Society (AHS) in Boston. The first study, dubbed Occipital Nerve Stimulation for the Treatment of Intractable Migraine (ONSTIM), has evaluated Medtronic's Synergy® neurostimulation device.

Medtronic, predictably, is quite excited about the possibility that occipital nerve stimulation one day might become a treatment option for migraine sufferers who are resistant to all other therapies:

The ONSTIM study, sponsored by Medtronic and conducted under an investigational device exemption (IDE), collected electronic diary data from 66 patients from nine centers who were followed for three months. The data to be reported at the AHS meeting include the average change in the number of headache days per month, overall pain intensity and the responder rate based on at least a 50 percent reduction in headache days per month or at least a three-point reduction in overall pain intensity.
"The ONSTIM results suggest that occipital nerve stimulation, or ONS, may be a promising therapy option for individuals who have not had success in treating their chronic migraine and as a result are living with the painful and often debilitating symptoms," said Dr. Joel R. Saper, M.D., founder and director of the Michigan Head Pain and Neurological Institute, Ann Arbor, Mich., and principal investigator for the ONSTIM study. "While ONS for chronic migraine requires additional clinical evaluation, our early experience in this study is encouraging and indicates that ONS could possibly help some chronic migraine patients who have exhausted other treatment options."

In the study, thin lead wires were placed under the skin near the occipital nerves, which arise from the spinal cord and branch out across the back of the head carrying sensory signals from that region to the brain. The leads were connected to an implanted Medtronic neurostimulator that delivered controlled electrical pulses to the occipital nerves. Patients were randomized to three groups to receive: either a neurostimulator and have the ability to control the level of stimulation; or a neurostimulator as part of a device control group; or only standard medical management instead of an ONS implant. A positive response was defined as at least a 50 percent reduction in the number of headache days in a month, or a reduction in the pain intensity of at least three points on a standard 0-10 pain scale. In addition to evaluating the efficacy of ONS therapy, the ONSTIM trial was designed to follow patients out to three years related to safety.

In other news from the headache front, investigators from the Ohio State University Medical Center are continuing to test a noninvasive portable transcranial magnetic stimulator (TMS) from Sunnyvale, CA based Neuralieve Inc., as a potential treatment for migraines. First reported by us back in June 2006, the device seems to be effective in not only reducing the symptomatology of migraines, but actually in treating them.

The press release from Ohio State explains:

Results of the study, to be presented Friday (6/27) at the annual American Headache Society meeting in Boston, found that the experimental device is safe and effective in eliminating headaches when administered during the onset of the migraine...
Of the 164 patients involved in the multi-center, randomized clinical trial receiving TMS treatment, 39 percent were pain free at the two-hour post-treatment point, compared to 22 percent in the group receiving "sham" pulses. There were no differences reported related to adverse reactions between the two groups.

Medtronic press release: Medtronic Announces First Clinical Data on Occipital Nerve Stimulation for Chronic Migraine to be Presented at American Headache Society Meeting ...

Ohio State University Medical Center press release: Portable Device Effective in Zapping Away Migraine Pain ...

Neuralieve press release: New Technology Provides Drug-Free Approach to Treat Migraine...

Medgadget archives: TMS

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Insulin Nanopump Prototype From Debiotech

Filed under: Medicine , Pediatrics

Debiotech S.A of Lausanne, Switzerland has produced the first prototypes of the company's tiny insulin pump, a device we've reported back in April 2007.

The working principle is a volumetric membrane pump, with a pair of check valves, integrated in a MEMS chip. The chip is a stack of 3 layers bonded together: a silicon on insulator (SOI) plate with micromachined pump-structures and two Pyrex cover plates with through-holes. This MEMS chip is assembled with a piezoelectric actuator that moves the membrane in a reciprocating movement to compress and decompress the fluid in the pumping chamber.

The design and manufacturing process of the Nanopump™ starts with silicon on insulator (SOI) wafers. Such wafers are used as the starting material in the fabrication of the latest and fastest computer chips. For the Nanopump™ the SOI wafers allow to increase the precision while shrinking the size of the chip. At its small size, numerous chips can be manufactured at the same time on one wafer, minimizing the cost per chip.

Constant and accurate flow rate is guaranteed through the control of the displacement of the pumping membrane. The movement occurs between two mechanical stops defined by the construction of the chip. As a consequence, the flow rate is linear with actuation frequency and virtually insensitive to inlet and outlet pressure, actuation voltage, temperature, viscosity and aging.

More from the Nanopump technology page...

Device page: Insulin Nanopump...

Press release: STMicroelectronics and Debiotech Announce First Prototypes of Disposable Insulin Nanopump...

Some Worrying News for Clinical RFID Industry

Filed under: Society

A Dutch study published in the June 25 issue of JAMA assessed the effects of electromagnetic interference (EMI) from RFID (radio frequency identification) devices on hospital equipment. The authors report that they have discovered that critical care gadgets can undergo major malfunctions thanks to EMI.

Here's the nugget from the American Medical Association press release:

Remko van der Togt, M.Sc., of Vrije University, Amsterdam, the Netherlands, and colleagues conducted a study in a controlled, non-clinical setting to assess and classify incidents of electromagnetic interference by RFID on critical care equipment. The tests were performed in a one-bed patient room in an intensive care unit (ICU) and with no patients present. Electromagnetic interference by two RFID systems (active [with batteries and ability to transmit information] and passive [without batteries, information retrieved by RFID reader] was assessed in the proximity of 41 medical devices (in 17 categories, 22 different manufacturers). The devices included items such as external pacemakers, mechanical ventilators, infusion/syringe pumps, dialysis devices, defibrillators, monitors and anesthesia devices. Incidents of EMI were classified according to a critical care adverse events scale as hazardous, significant, or light.

All 41 medical devices were submitted to 3 EMI tests resulting in 123 EMI tests. A total of 34 EMI incidents were found; 22 were classified as hazardous, 2 as significant, and 10 as light. The passive signal induced a higher number of incidents (26 in 41 EMI tests; 63 percent), and hazardous incidents (17), compared with the active signal.

Hazardous incidents included: total switch-off and change in set ventilation rate of mechanical ventilators; complete stoppage of syringe pumps; malfunction of external pacemakers; complete stoppage of renal replacement devices, and interference in the atrial and ventricular electrogram curve read by the pacemaker programmer.

The median (midpoint) distance between reader and device at which all types of incidents occurred was 11.8 inches. Hazardous incidents occurred at a median distance of 9.8 inches.

Press release: ELECTROMAGNETIC INTERFERENCE FROM SOME RADIO FREQUENCY IDENTIFICATION DEVICES MAY POSE HAZARDS TO MEDICAL EQUIPMENT ...

Abstract: Electromagnetic Interference From Radio Frequency Identification Inducing Potentially Hazardous Incidents in Critical Care Medical Equipment JAMA. 2008;299(24):2884-2890.

Image credit: lyzadanger @ Flickr: Tags Before Surgery

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Smart Brain-Computer Interface Learns with the Brain

Filed under: Neurological Surgery , Neurology

Neural interfaces have gone through a lot of development and refinement in the last few years, becoming more sensitive and having greater ability to focus on electric signals in the brain. At the University of Florida researchers have developed an algorithm that helps the interface learn from previous events, leading to better performance in subsequent ones.

Until now, brain-machine interfaces have been designed as one-way conversations between the brain and a computer, with the brain doing all the talking and the computer following commands. The system UF engineers created actually allows the computer to have a say in that conversation, too, according to findings published this month online in the Institute of Electrical and Electronics Engineers journal IEEE Transactions on Biomedical Engineering.
"In the grand scheme of brain-machine interfaces, this is a complete paradigm change," said Justin C. Sanchez, Ph.D., a UF assistant professor of pediatric neurology and the study's senior author. "This idea opens up all kinds of possibilities for how we interact with devices. It's not just about giving instructions but about those devices assisting us in a common goal. You know the goal, the computer knows the goal and you work together to solve the task."

Scientists at UF and other institutions have been studying and refining brain-machine interfaces for years, developing and testing numerous variations of the technology with the goal of creating implantable, computer-chip-sized devices capable of controlling limbs or treating diseases.

The devices are programmed with complex algorithms that interpret thoughts. But the algorithms, or code, used in current brain-machine interfaces don't adapt to change, Sanchez said.

"The status quo of brain-machine interfaces that are out there have static and fixed decoding algorithms, which assume a person thinks one way for all time," he said. "We learn throughout our lives and come into different scenarios, so you need to develop a paradigm that allows interaction and growth."

To create this type of brain-machine interface, Sanchez and his colleagues developed a system based on setting goals and giving rewards.

Fitted with tiny electrodes in their brains to capture signals for the computer to unravel, three rats were taught to move a robotic arm toward a target with just their thoughts. Each time they succeeded, the rats were rewarded with a drop of water.

The computer's goal, on the other hand, was to earn as many points as possible, Sanchez said. The closer a rat moved the arm to the target, the more points the computer received, giving it incentive to determine which brain signals lead to the most rewards, making the process more efficient for the rat. The researchers conducted several tests with the rats, requiring them to hit targets that were farther and farther away. Despite this increasing difficulty, the rats completed the tasks more efficiently over time and did so at a significantly higher rate than if they had just aimed correctly by chance, Sanchez said.

Press release: Researchers develop neural implant that learns with the brain ...

(hat tip: Thomas A. and Next Big Future)

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Frost & Sullivan's Growth Innovation and Leadership Conference

Filed under:

Medgadget is partnering with Frost & Sullivan for this year's 4th Annual Growth Innovation and Leadership 2008: A Frost & Sullivan Global Congress on Corporate Growth conference, a meeting of medical technology executives in San Francisco to be held September 14 - 16, 2008. On the agenda are meets and greets, and talks on corporate innovation and acceleration of growth strategies. Professional executives should find this gathering both informative and a reliable source for networking within the industry.

For the agenda and to claim a Medgadget registration discount, see more complete details below the fold.

Thursday, June 26, 2008

On Hiatus

Filed under:

The editorial staff will be taking some much needed sleep to rejuvenate from recent clinical duties. We'll be back tomorrow to give you the fresh scoop on all the latest medical technology.

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Wednesday, June 25, 2008

Two-Legged Puppy Overcomes Disability With Unbearable Cuteness

Filed under: etc.

The aptly named puppy Hope was born without two front legs. But her problem appears to be solved thanks to her incredible level of adorability, and a talented team of puppy professionals that includes a rehab therapist and an orthotist.

A custom prosthetic was made for Hope using a molded body piece attached to hinged model airplane wheels. The device allows her to turn, lie down, and propel herself forward easily using her hind legs.

Before the prosthetic Hope had to move around by hopping. Puppy healthcare experts were worried that this would soon damage her bones and internal organs. Hope's only concern now will be running/rolling away from her innumerable instant-fans.

Read the full story here...

(Hat Tip: Gizmodo)

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Panasonic U1 Ultra Mini Computer

Filed under: Informatics

Panasonic today unveiled its new computer in the venerable Toughbook line of PC's designed to perform in an environment somewhat more rugged than your lap. We had the ER in mind as a place where the new U1 can be tested.

The U1 UMPC (Ultra-Mini PC) is a full featured computer running Windows XP or Vista on the new Intel Atom processor, fully compatible with any PC application. Coupled with Toughbook's standard safety components, like withstanding a four foot drop onto concrete, the device may prove to be a winner among doctors and nurses working in hospital wards.

What makes the U1 especially suited for healthcare is a combination of the design considerations put into it. Because of the cooler, more efficient Intel Atom processor, the U1 doesn't have ventilation ports through which liquids can enter. The device is effectively sealed, and Panasonic claims that it can take a good splash (of urine or C. diff., we assume) and keep on ticking. (Just don't take it SCUBA diving with you. Its not fully water proof.)

Nursing staff and the IT department will also be happy to know that the U1 sports two separate battery slots, which lets the user hot-swap batteries without having to turn off the unit. A hospital can even buy multi-battery chargers to hang on the wall at the nurse's stations for round the clock operation. Somehow this feature seems like it was specifically designed with nurses in mind, who already have enough to think about without having to deal with complicated battery changes during busy hours.

The screen is 5.6 inches and is fully touch sensitive, which means it can be controlled with your finger, not just the stylus like so many tablets out there require. (The advantage becomes obvious once the stylus is accidentally left back at the desk.)

Optionally it can come with a bar code scanner, which can be utilized for device or medication tracking, and a built-in webcam, which we envision can be employed in a futuristic communication system between clinicians in a hospital ward.

We're really impressed by the U1, and would like to see more portable computers come out suitable for use in hospitals. Not to say that this is a good general replacement for a real laptop, as it has only 1GB RAM and tops out at 32 GB for a solid state disk drive. But its nice to have all the data and tomographic images of the patient wirelessly accessible at the bedside.

Press release: Panasonic Unveils the Handheld Toughbook CF-U1, a Rugged Ultra Mobile PC for Field Workers in Extreme Environments ...

Product page: Toughbook U1 ...

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Personalized Medical Search Engine: With Medgadget

Filed under: Net News

Our "international" editor Berci has been working on a bunch of projects over at Scienceroll. One of the projects he's been testing is Scienceroll Search, a personalized medical search engine powered by Polymeta.com. You can choose which databases to search in and which to exclude from your list. It works with well-known medical databases and there is an open discussion about which new sources to use. Essentially it's up to the users.

Now you can search in the database through Medgadget posts as well. For example, if you would like to find diabetes-related medical tools and gadgets, just click on Medgadget and make a search:

And you not just get some relevant results, but you can use the topic clusters to get closer to the information you need.

More at Scienceroll Search...

Coverage at Scienceroll.com...

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Should FDA Approval Waive Liability?

Filed under: in the news...

You know who would make a logical spokesperson for medical liability policy? The guy who starred in the 1998 remake of The Parent Trap. That's right, Dennis Quaid is making the case that he should be able to sue pharma giant Baxter over a dosing error that nearly killed his baby twins...

Quaid last month urged Congress to preserve patients' rights to sue drug and device makers in state courts, after his twin newborns nearly died after accidentally overdosing on a blood-thinning drug sold by Baxter International. He has sued the company.

While Quaid's example is clearly ridiculous on account of the fact that it was a facility error, not Baxter's, Reuters goes on to highlight that...

...Democrats in Congress are considering legislation to protect a patient's ability to sue drugmakers if the Supreme Court further restricts the lawsuits, backing so-called "pre-emption" of state laws by federal.

This all, of course, comes in the wake of the recent decision that the manufacturer of a device that's gone through the PMA process cannot be held liable.

That said, the effect upon medical innovation of leaving the door open to liability at a state level would be disastrous. At best, it increases the legal overhead associated with doing business as a device or drug manufacturer, thus further increasing the cost of medical care.

However, worse than that, it takes the focus off of the root cause: the purpose of the FDA is to ensure the safety and efficacy of the medical products on the market. If a faulty product slips through (as is inevitably the case), the liability lies with the arbiter of "good enough": the FDA.

If being good enough for the FDA isn't, then the federal government might as well dissolve the agency and spend our tax dollars elsewhere, letting case law (and lay-person juries) decide what the public requires in terms of safety. Obviously a less desirable solution, but it remains the only logically intact one should we leave the door open for every ambulance chaser to try and extract a ransom from big-name medical manufacturers.

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Tuesday, June 24, 2008

Over and Under Pericardium Covered Stent from ITGI Medical

Filed under: Cardiac Surgery , Cardiology , Radiology

We just learned of a new coronary stent from ITGI Medical of Or Akiva, Israel that has recently started being used in Europe. Called Over and Under® Pericardium Covered Stent (PCS), the device is thought to be indicated for the treatment of bypass stenosis (as in degenerated Saphenous Vein Graft (SVG) in patients who are status post CABG), as well as for aneurysms and for emergency situations such as perforations.

Here's what Frost and Sullivan, a consultancy firm, thought about the device and the future for its clinical applications:

In order to address problems that may compound due to events triggered by arterial lumen renarrowing and thrombosis, and the need to avoid the use of antiplatelet therapy, Or Akiva, Israel based ITGI Medical Ltd., has developed a stent that is covered with heterologous tissue. Called the Over and Under Pericardium Covered Stent (PCS), the scaffold sets a barrier between the coronary blood vessel wall and its lumen. What makes the product unique is that it is 100% covered, is biocompatible, and is highly flexible. Typical indications would include the use of these in situations such as degenerated saphenous vein graft (SVG), aneurysms and perforations. Talking to Technical Insights on the basis of having developed a pericardial tissue covered stent, Efri Argaman, CEO said, "The stenting market is divided between different segments and about 85% of the indications make use of the bare metal stents or the drug eluting stents currently available. The relatively big niche of indication within the coronary arena, which translates to about 10% of the total stent market, requires the separation of the blood from the blood vessel wall and the lumen. Our company has exclusively forayed into this segment that has involved indications of plaque inside the saphenous vein graft and coronary aneurysms largely."
The Over and Under heterologous PCS has a stainless steel structure that has been specially designed to host a pericardium cylinder and can be used to create an expandable graft. Some of the advantages would include a low-profile feature allowing deployment in narrow lumens, achieved through low pressure of 5 atmospheres. This reduces the risk for ruptures and restenosis. The flexible nature of the stent allows for navigation through the tortuous vessel. The equine pericardium used over the stent is highly flexible and provides 100% coverage. Talking further on the use of equine pericardial tissue, Argaman said, "The issue of biocompatibility in small diameters made us choose a biomaterial that was highly biocompatible and stronger than the existing polymer material, eptfe (polytetrafluoroethylene)."

Future applications include the use of Over and Under for brain aneurysms due to its ability to isolate the aneurysm from the blood system and its use in the hepatic artery.

Product page: Over and Under® Pericardium Covered Stent ...

Press release: ITGI Medical launches Over and Under® Pericardium Covered Stent in England, Switzerland and Ireland (.pdf)...

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Non-Metal Ankle Replacement Available at UCSD

Filed under: Orthopedic Surgery

A successful study in the Journal of Foot & Ankle Surgery that describes a new ankle replacement technique, that involves the use of a collagen-like material, is going to be published later this year. This pioneering idea came from Daniel K. Lee, who is the director of foot and ankle surgery at UCSD Medical Center.

Classically, most ankle replacements are made from metals like titanium or steel. While knee and hip replacements made from these materials have been incredibly successful, ankle replacements have been plagued by fractures and other complications.

Here is more on the new technique from a UC press release:

During a two hour minimally-invasive surgical procedure, Lee, a podiatric foot and ankle surgeon, removes the damaged cartilage around the ankle joint through a four centimeter incision. The collagen material is then molded into the joint where it adapts to the contour of the patient's ankle.
"Unlike a metal device, the advantage to this material is that the implant can be customized in size and contour for every patient's individual need," said Lee. "No matter how the patient's ankle is shaped, the collagen is a perfect fit."

The biologic material, processed from either human or animal collagen sources, has been used for more than 10 years in plastic and abdominal surgery and heart valve replacement. Since it is non-allergenic and sterile in nature, there is no risk of rejection or need for the patient to take immunosupressors.

..."Within three weeks after surgery, we see an incorporation of tissue onto the damaged cartilage," said Lee. "The idea here is to avoid fusion of the ankle and to add longevity to the joint. We want to give patients as much mobility as possible so they can get back to the activities they love the most."

Chair-A-Table for Heavy Examinations

Filed under: Rehab

Martin Innovations, of Apex, North Carolina, is a company that has developed an innovative exam chair/table, which takes the strain off the nurse's back. Designed for a wheel chair to dock onto the unit, the device requires virtually no muscle exertion on the part of the caretaker.

Watch this video demonstration of the Chair-A-Table:

Product page: Chair-A-Table ...

Product brochure (.pdf)...

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