
As the year 2008 is about to enter history books, we’d like to thank all our readers for your patronage and support, and to wish you a happy, safe, and prosperous new year.
Here at Medgadget we strive hard to deliver to you the latest, most relevant, and most exciting medical technology news. For a group of clinicians, working full time at our regular jobs, and blogging at our free times, we think we deliver one of the most active medical technology news sites on the web. And our effort seems to pay off. In 2008 we put out more posts and saw our readership rise like never before.
Next year we pledge to continue offering our daily coverage while striving for more depth, breadth, and analysis of the news in science and technology of medicine. And we will also make sure to keep it lively.
So please have a wonderful holiday, and we will see you here next year!
Archives: 12/2008
CeloNova BioSciences out of Newnan, Georgia has received FDA clearance for the firm’s Embozene Color-Advanced Microspheres for treatment of hypervascularized tumors. Classified as an embolic device, the microspheres are based on the company’s proprietary material poly[bis(trifluroexthoxy)phosphazene], or Polyzene®-F, described as “lubricious and flexible,” as well as “versatile, durable, and highly biocompatible.”
A while ago the European Union has cleared Embozene Color-Advanced Microspheres for marketing, and the device has been used by clinicians for embolizations of things like uterine fibroids, AVMs (ArterioVenous Malformations), hepatocellular carcinomas (HCC), and some other highly vascularized cancers. Back in January Medgadget had a post about CeloNova’s interesting polymer for other applications: Polyzene-F Nanocoating for Cardiac Stents.
From the press release issued by CeloNova:
Embozene(TM) Microspheres are the first and only microspheres to be color- enhanced with a different color for each size for increased procedural safety, efficiency and visibility. They are also available in a wider range of sizes than any other spherical embolic on the market. They are available in 40 micrometers, 100 micrometers, 250 micrometers, 400 micrometers, 500 micrometers, 700 micrometers, and 900 micrometers sizes in 1 ml and 2 ml pre-filled syringes and vials. CeloNova plans to submit a supplemental 510(k) to the FDA to add three additional sizes, 75 micrometers, 1100 micrometers and 1300 micrometers, for a total of ten sizes including the smallest and the largest microspheres available for endovascular therapy. CeloNova is the only Company that provides this complete range of products.
CeloNova’s Embozene(TM) Microspheres consist of a hydrogel core and an exterior shell made from Polyzene®-F, CeloNova’s proprietary polymer which is known to be anti-inflammatory and bacterial-resistant. Four design features distinguish Embozene(TM) Microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability. Embozene(TM) Microspheres are precisely calibrated, they retain their shape after passing through a catheter, and they can stay in suspension for an extended time. The unique color enhancement of the microspheres and finely calibrated sizes make selection easy, efficient, and precise for the operator. The result is an embolic microsphere that provides accurate and complete vessel occlusion.
Embolization is a minimally invasive procedure used to control or prevent abnormal bleeding, to shrink tumors by blocking the blood vessels that supply them, and to block off blood vessel malformations. Physicians use enhanced imaging techniques to visualize the blood vessel, then insert and advance a catheter to the treatment site. The embolic agent is then released into the catheter and positioned within the blood vessel or malformation to block the target vessel permanently.
“Embozene Microspheres are an innovative advance in embolic technology that has been well received outside the U.S.,” said John C. Lipman, MD, FSIR, Founder and CEO of the Atlanta Interventional Institute and Director of the Center for Image-Guided Medicine at Emory-Adventist Hospital Atlanta. “Intuitively, a polymer that is anti-inflammatory and that provides more finely calibrated bead sizes, shape integrity, prolonged suspension, and has a unique color-coded selection system that makes for more efficient procedures, will appeal to physicians as well as patients. Embozene(TM) Microspheres maintain suspension better than any other embolic I’ve seen,” said Dr. Lipman. “I’m looking forward to using this therapy in my practice.”
“From the outset, we took a different approach to developing our Embozene(TM) Microspheres by asking physicians and medical scientists for the qualities and characteristics that the ideal embolic device should have,” said Thomas A. Gordy, President and Chief Executive Officer, CeloNova BioSciences, Inc. “Then, we engineered Embozene(TM) Microspheres to have those properties, which are made even better with Polyzene®-F, our proprietary polymer. Polyzene®-F helps make our leading-edge technology better.”
Product page: Embozene™ Color-Advanced Microspheres …
Press release: CeloNova BioSciences Receives FDA Market Approval for Embozene(TM) Color-Advanced Microspheres Embolization Platform…
Product brochure (.pdf)…
Flashback: Polyzene-F Nanocoating for Cardiac Stents

MIT researchers have developed a computer modeling technique to assist in the fight against malaria, a disease which still accounts for 1/3rd of all deaths in children under 5 worldwide. The software analyzes numerous environment factors involved in malaria spread and can help predict what various interventions will have. Targeting environmental factors is not new, but being able to quantify the lasting effects of environmental interventions (such as leveling ground, planting trees in stagnant water, etc.) is.
MIT press office explains:
Modifying the environment by using everything from shovels and plows to plant-derived pesticides may be as important as mosquito nets and vaccinations in the fight against malaria, according to a computerized analysis by MIT researchers.
The researchers have developed a new computer model for analyzing different methods of trying to control the spread of malaria, one of the world’s most-devastating diseases. Among their findings using the model is that environmental measures such as leveling the land to eliminate depressions where pools can form can be an important part of the strategy for controlling the disease.
Reports on the work, carried out by Professor of Civil and Environmental Engineering Elfatih Eltahir and graduate students Arne Bomblies and Rebecca Gianotti, were presented this week at a meeting of the American Geophysical Union in San Francisco…
While most efforts at dealing with malaria have focused on the human side, such as attempts to develop a vaccine, Eltahir said that efforts to control environmental factors –such as working to eliminate the low spots where pools of water collect during the rainy season, or applying locally grown plant materials to limit the growth of mosquitoes — can have a dramatic effect on controlling malaria’s spread. And unlike importing expensive medicines, such an approach can rely on local efforts as simple as having people with shovels fill in the low spots in the terrain.
“By using local tools and local labor, our approach relies less on high-technology equipment from outside the region, which tends to make the local people more dependent,” he said.
In addition, the new comprehensive computer model will provide a tool for analyzing how different areas’ vulnerability to malaria will be affected by a changing climate.
To validate the accuracy of the computer modeling of conditions, the team has been working for the last four years in a remote area of Niger, which lies in the Sahel desert region of northern Africa. “Africa is the hot spot for malaria in general,” Eltahir explained, so this fieldwork provides substantial validation of the model.
In the field, Bomblies and others have monitored every aspect of malaria’s lifecycle, including doing counts of mosquito larvae and adult mosquitoes, identifying the exact species of mosquitoes (since only specific varieties carry the malaria parasite), and mapping the topography and monitoring the size and duration of pools of water where the mosquitoes breed. “We gathered data that would serve as validation for the model that we were developing,” Bomblies said.
Eliminating pools of standing water, or increasing drainage so that such pools last less than the seven to 10 days it takes for the mosquitoes to mature, can be an effective strategy, the analysis shows. In addition, it allows comparison of different methods. Filling in the low spots using shovels, it turns out, is as effective at controlling the disease as plowing the land so that water more rapidly percolates down into the soil.
That is not a new idea, but the new software provides a quantitative way to compare its impact with other approaches, and to develop specific strategies for a given region. Filling in low spots “is an established technique,” said Bomblies, who has spent a total of 13 months leading the fieldwork in Niger. “But it hasn’t been specifically applied in the region in which we’ve been working.”
And unlike other approaches such as vaccinations or mosquito nets, it has a relatively permanent impact. “Once a breeding site is gone, it’s gone” Bomblies said.
Read more here: How to fight malaria by changing the environment…
Project page @ Eltahir Research Group: Monsoons, Mosquitos & Malaria
Princeton scientists have developed a new more energy efficient way to generate laser light. The finding should allow for building of miniature diagnostic devices that monitor light’s attenuation in a liquid sample, potentially leading to specialized blood glucose meters and other similar devices.
The laser used in the Princeton study is a special type called a quantum cascade laser. Built at Princeton University’s nanofabrication facility, the device is about one-tenth as thick as a human hair and 3 millimeters long. Despite its tiny size, it is made of hundreds of layers of different semiconductor materials. Each layer is only a few atoms thick. In this device, electrons “cascade” down through the layers as they lose energy and give off synchronized photons.
In an earlier study published in Applied Physics Letters in June 2007, Franz [graduate student Kale Franz], Gmachl [Claire Gmachl, an electrical engineer and director of the Mid-Infrared Technologies for Health and the Environment (MIRTHE) center --ed.] and others had reported that a quantum cascade laser they had built unexpectedly emitted a second laser beam of slightly smaller wavelength than the main one. Further studies by Menzel and others revealed that the second beam could not be explained by any existing theory of quantum cascade lasers. Unlike a conventional semiconductor laser, the second beam grew stronger as the temperature increased, up to a point. Further, it seemed to compete with the “normal” laser, growing weaker as the latter strengthened when more electric current was supplied. “It’s a new mechanism of light emission from semiconductor lasers,” said Franz.
To explain this mechanism, the researchers invoked a quantum property of electrons called momentum. In the conventional view of quantum cascade lasers, only electrons of nearly zero momentum participate in “lasing” (producing laser light). Further, a substantial number of electrons has to attain the same level of energy and momentum – be in a so-called “quasi-equilibrium” condition — before they can participate in laser action. In contrast, studies by Gmachl’s group showed that the second laser beam originated from electrons of lower energy, but higher momentum that were not in equilibrium. “It showed, contrary to what was believed, that electrons are useful for laser emission even when they are in highly non-equilibrium states,” said Franz.
The new laser phenomenon has some interesting features. For instance, in a conventional laser relying on low momentum electrons, electrons often reabsorb the emitted photons, and this reduces overall efficiency. In the new type of laser, however, this absorption is reduced by 90%, said Franz. This could potentially allow the device to run at lower currents, and also makes it less vulnerable to temperature changes. “It should let us dramatically improve laser performance,” he said.
The device used in the study does not fully attain this level of performance, because the conventional, low-efficiency laser mechanism dominates. To take full advantage of the new discovery, therefore, the conventional mechanism would need to be turned off. The researchers have started to work on methods to achieve this outcome, said Franz.
Unlike other lasers, quantum cascade lasers operate in the mid- and far-infrared range, and can be used to detect even minute traces of water vapor, ammonia, nitrogen oxides, and other gases that absorb infrared light. As a result, these devices are finding applications in air quality monitoring, medical diagnostics, homeland security, and other areas that require extremely sensitive detection of different chemicals.
Press release: Princeton researchers discover new type of laser…
For people vigilant about their caffeine intake comes a new product that can test their decafs on the go. The D+caf test strips from Silver Lake Research Corporation out of Monrovia, California, can tell whether a six ounce cup of joe has more than 20mg of caffeine.
Some notes from the product page:
D+caf™ Test Strips enable you to test the caffeine concentration of coffee and tea. 20 single-use test strips 98% accurate for detecting “NON-DECAFFEINATED” beverages – above 20 mg caffeine per 6 oz. serving D+caf™ is a lateral flow immunoassay, similar to the technology used in home pregnancy tests D+caf™ Test Strips can be used on hot or cold beverages Produces a result in as little as 30 seconds Test beverage before adding milk, cream, powdered creamers, syrups or other additives
Product page: Caffeine Test Strips …
(hat tip: MIT Tech Review)
Who would have thought there would be a reason to make sugar-free antibodies? Well, researches at MIT did! It has long been thought that a particular sugar attachment was required for antibody function but new research shows this to not be the case. This opens the door to mass producing therapeutic antibodies by bacteria or fungi.
MIT engineers have found that antibodies do not need a particular sugar attachment long believed to be essential to their function, a discovery that could make producing therapeutic antibodies much easier and cheaper in the future.
Therapeutic antibodies are a promising new type of treatment for cancer and other diseases, but their practicality has been limited by the fact that only mammalian cells have the right machinery to build the sugar attachment.
“To date, people have faced limitations in how they were going to make these antibodies because they appeared to require these (sugar) structures,” said Dane Wittrup, the C.P. Dubbs Professor of Chemical Engineering, Biological Engineering, member of the Koch Institute for Integrative Cancer Research, and senior author of a paper on the work that appeared in the Dec. 12 online edition of the Proceedings of the National Academy of Sciences.
Wittrup and biological engineering graduate student Stephen Sazinsky, co-lead author of the paper, found that antibodies don’t need the sugar normally found attached to a certain region of antibody when the sequence is slightly mutated.
Antibodies are a key part of the immune system, roaming around the body to detect invaders such as bacteria and viruses. Each antibody is specific to a particular pathogen. When an antibody finds its target, it first binds to the pathogen, then binds to immune cells, alerting them to attack the pathogen.
The attached sugar was believed necessary to allow antibodies to bind to immune cells, such as NK (natural killer) cells and macrophages. However, the MIT team found that mutant forms of the antibody with no sugar were also able to bind to immune cells.
Knowing this, scientists will now be able to develop therapeutic antibodies that can be mass-produced by bacteria or fungi, a process that is cheaper and faster than using mammalian cells.
There are now dozens of FDA-approved antibody treatments, and hundreds more are in clinical trials. Such therapeutic antibodies can be used to treat cancer, autoimmune diseases, cardiovascular disease and many others.
The new discovery also raises the question of why the sugars are attached to antibodies in the first place. Sazinsky theorizes that the sugar has been evolutionarily conserved as a way for the immune system (and now scientists) to tinker with the binding affinities of different antibodies.
Other authors of the paper are co-lead author Rene Ott of Rockefeller University; Nathaniel Silver, an MIT graduate student in chemistry; Bruce Tidor, MIT professor of biological engineering and computer science; and Jeffrey Ravetch of Rockefeller University.
The research was funded by the National Cancer Institute and the National Institutes of Health.
MIT News press release: Surprising find could lead to better manufacturing options for cancer-fighting antibodies…
At Christmas play and make good cheer,
For Christmas comes but once a year – Thomas Tusser
Do your New Year’s resolutions include losing weight and cutting back on a few of your indulgences? May not be a bad idea, but just in case you need another rationalization during the holidays, researchers at Oxford have released a study showing that brain performance is boosted by chocolate, wine, and tea!
All that chocolate might actually help finish the bumper Christmas crossword over the seasonal period. According to Oxford researchers working with colleagues in Norway, chocolate, wine and tea enhance cognitive performance.
The team from Oxford’s Department of Physiology, Anatomy and Genetics and Norway examined the relation between cognitive performance and the intake of three common foodstuffs that contain flavonoids (chocolate, wine, and tea) in 2,031 older people (aged between 70 and 74).
Participants filled in information about their habitual food intake and underwent a battery of cognitive tests.Those who consumed chocolate, wine, or tea had significantly better mean test scores and lower prevalence of poor cognitive performance than those who did not. The team reported their findings in the Journal of Nutrition.
The role of micronutrients in age-related cognitive decline is being increasingly studied. Fruits and beverages such as tea, red wine, cocoa, and coffee are major dietary sources of polyphenols, micronutrients found in plant-derived foods. The largest subclass of dietary polyphenols is flavonoids, and it has been reported in the past that those who consume lots of flavonoids have a lower incidence of dementia.
The latest findings seem to support the theory, although the researchers caution that more research would be needed to prove that it was flavonoids, rather than some other aspect of the foods studied, that made the difference.The effect was most pronounced for wine.
However, say the researchers, those overdoing it at Christmas should note that while moderate alcohol consumption is associated with better cognitive function and reduced risk of Alzheimer’s disease and dementia, heavy alcohol intake could be one of many causes of dementia – as well as a host of other health problems.
University of Oxford press release: Chocolate, wine and tea improve brain performance…
Could the promising world of gene-therapy even make geeks more popular? A study released by behavioral geneticist S. Alexandra Burt of the Michigan State University demonstrates that the behavioral expression of a “rule-breaking” gene is linked to popularity in adolescents. So that’s why the “bad-guys” got all the babes
A groundbreaking study of popularity by a Michigan State University scientist has found that genes elicit not only specific behaviors but also the social consequences of those behaviors.
According to the investigation by behavioral geneticist S. Alexandra Burt, male college students who had a gene associated with rule-breaking behavior were rated most popular by a group of previously unacquainted peers.
It’s not unusual for adolescent rule-breakers to be well-liked – previous research has made that link – but Burt is the first to provide meaningful evidence for the role of a specific gene in this process. The study appears in the latest issue of the Journal of Personality and Social Psychology, which is published by the American Psychological Association.
“The idea is that your genes predispose you to certain behaviors and those behaviors elicit different kinds of social reactions from others,” said Burt, assistant professor of psychology. “And so what’s happening is, your genes are to some extent driving your social experiences.”
The concept – which researchers call “evocative gene-environment correlation” – had been discussed in scientific literature but only in theory. This study is the first to really flesh out the process, establishing clear connections between a specific gene, particular behaviors and actual social situations, she said.
Burt collected DNA from more than 200 male college students in two separate samples. After interacting in a lab setting for about an hour, the students filled out a questionnaire about whom they most liked in their group. In both samples, the most popular students turned out to be the ones with a particular form of a serotonin gene that was also associated with rule-breaking behavior.
“So the gene predisposed them to rule-breaking behavior and their rule-breaking behavior made them more popular,” Burt said.
Burt is working on similar studies with female college students, as well as mixed-gender social groups. She also plans to explore associations with other social behaviors and other genes in larger samples.
Press release: MSU research: Genes may influence popularity…

Haemair Ltd., a Welsh company out of Swansea, has won this year’s Stopford Projects Award for Bioprocess Innovation from the UK’s Institution of Chemical Engineers. The company says that it is working on a compact prosthetic lung capable of doing the gas exchange for conscious and mobile patients. How different the device will be from the ECMO systems we have nowadays, we simply don’t know. In addition to developing specialty hardware needed by the device, the company says the software is being built to automatically control the exchange rate and air pressure in the system to adjust for the changing metabolic needs of the subject. The company plans to begin clinical trials soon at Swansea University.
From Haemair’s device page:
The unique feature of the Haemair approach is that it is aimed at conscious mobile patients. To this end, we match oxygen and carbon dioxide External Respiratory Device mass transfer rates to the respiratory demand of the patient. Furthermore, we employ a flow of natural air to provide oxygen and remove carbon dioxide.
There are three main variants of our device. The simplest to employ consists of a mass exchanger, as illustrated in figure 3. It takes deoxygenated blood, extracted from a main vein, removes carbon dioxide, replaces it with oxygen, and returns the oxygenated blood to the body. The second variant places the mass exchanger within the body to eliminate the hazard of taking a significant blood flow outside the body. The final version is a prosthetic lung, as illustrated in figure 2.
In all three variants, mass transfer is controlled so that performance mimics that of natural lungs. In this way, the natural respiratory control mechanism controls heart rate etc, and control is fully integrated with the natural respiratory system.
The external device will be deployed first. It is easily reversible and major parts are available for maintenance. The easy reversibility is important in treating emergency and acute cases for which the device might be needed for no more than hours or weeks. Once we have established that long maintenance-free operation is possible, we can move on to the intermediate device. The clinical procedure to “plumb” the device into the blood circulation system is more complex and maintenance is more difficult. However, the engineering is simpler. The only significant external item required is a small air pump, or fan. This device is more suited to patients who will need it for months – for example, as a bridge to transplant. It should enable patients to leave hospital and continue treatment at home. The final variant, a prosthetic lung, serves as an alternative to a lung transplant. This variant is illustrated in figure 3. It cannot be deployed until we have extensive favourable experience with the reversible devices. However, it offers hope to those currently excluded from transplant waiting lists – for example, most terminal emphysema sufferers.
Device page: Haemair Respiratory Aid and Prosthetic Lung …
IChemE Awards 2008 page…





CeloNova’s Embozene(TM) Microspheres consist of a hydrogel core and an exterior shell made from Polyzene®-F, CeloNova’s proprietary polymer which is known to be anti-inflammatory and bacterial-resistant. Four design features distinguish Embozene(TM) Microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability. Embozene(TM) Microspheres are precisely calibrated, they retain their shape after passing through a catheter, and they can stay in suspension for an extended time. The unique color enhancement of the microspheres and finely calibrated sizes make selection easy, efficient, and precise for the operator. The result is an embolic microsphere that provides accurate and complete vessel occlusion.
The external device will be deployed first. It is easily reversible and major parts are available for maintenance. The easy reversibility is important in treating emergency and acute cases for which the device might be needed for no more than hours or weeks. Once we have established that long maintenance-free operation is possible, we can move on to the intermediate device. The clinical procedure to “plumb” the device into the blood circulation system is more complex and maintenance is more difficult. However, the engineering is simpler. The only significant external item required is a small air pump, or fan. This device is more suited to patients who will need it for months – for example, as a bridge to transplant. It should enable patients to leave hospital and continue treatment at home. The final variant, a prosthetic lung, serves as an alternative to a lung transplant. This variant is illustrated in figure 3. It cannot be deployed until we have extensive favourable experience with the reversible devices. However, it offers hope to those currently excluded from transplant waiting lists – for example, most terminal emphysema sufferers. 




