e-HealthExpert.org - Primum non nocere

Devax, from Irvine, California, has received CE approval for its AXXESS Biolimus A9 eluting coronary bifurcation stent. Stenosis of the coronary bifurcation is relatively common due to atherosclerosis developing at branch points because of turbulence and high shear stress. According to studies by Devax, lesions located at vessel bifurcations increase the frequency of major adverse cardiac events by as much as 40% compared to lesions in straight vessel segments. From the press release: The Devax AXXESS System technology is a proprietary self-expanding Nitinol stent specifically designed for the treatment of coronary and vascular bifurcation lesions. The conical shape of the stent is designed to conform to the bifurcation anatomy and provide full access to both branches for additional interventional procedures. Devax has licensed the drug Biolimus A9 and bioabsorbable coating from Biosensors International Group. Below the fold is an animation of the stent being placed and links to further info:... Wouter Stomp

BACK TO USSR: Institute for Safe Medication Practices: Drug Shortages 'Unprecedented'... [WSJ] FDA unveils proposed changes to 510(K) program... [MassDevice] Missouri Voters Overwhelmingly Reject Federal Mandate to Purchase Health Insurance... [STLToday] Drug trials funded by industry are more likely to publish favorable results... [Children's Hospital Boston] CPR Without Mouth-to-Mouth Rescue Breathing May Be Better for Many Victims of Cardiac Arrest... [Johns Hopkins] US tops international drug use ranking... [Nature Blogs] Roche May Lose $1 Billion a Year on Avastin Change... [Bloomberg] Covidien Completes Acquisition of Somanetics Corporation... [Covidien] Philips expands its clinical informatics portfolio with the acquisition of CDP business... [Philips ] St. Jude Medical Files Patent Infringement Lawsuit Against Volcano Corporation in the U.S.... [St. Jude Medical ] Ultrasound co Applisonix signs development deal with SLI ... [Globes] New Compound Improves Obesity-Related Health Complications... [NIH] Select Agents Should Be Defined by DNA Sequence... [NAS.org] Once bitten, twice shy - a temperature switch triggers aversive memory... [Max Planck Society] Of Bugs & Brains: Researchers Discover that Gut Bacteria Affect Multiple Sclerosis... [Caltech] A New Ground Zero for Prostate Cancer... [HHMI] Researchers Make Progress Toward Regenerating Tissue to Replace Joints... [NIH] Mechanical regulation of cell function with geometrically modulated elastomeric substrates ... [Nature Methods] UK's voluntary gene test 'crackdown'... [Nature Blogs] Does Thinner Air Make Coloradans, Well, Thinner? [WSJ]... Michael

Further advancing its popular endoscopic vessel harvesting technology for cardiac surgeons who are taking down veins for CABGs and other bypass grafts, MAQUET Cardiovascular has just introduced a new VASOVIEW HEMOPRO 2. According to the company, the minimally invasive system "utilizes next-generation HEMOPRO cut-and-seal technology to reduce thermal spread and to achieve optimal conduit quality for coronary artery bypass graft (CABG) surgery patients." The newly designed HEMOPRO 2 Jaws feature a unique insulated area, providing the main conduit maximum protection during side branch dissection. The HEMOPRO 2 Jaws also feature an enhanced edge for spot cautery to provide a clearer working tunnel and extended cutting capability to allow cutting even from within the innermost corner of the tool. These design changes improve the robustness of the EVH procedure and are easy for users to learn. The VASOVIEW HEMOPRO 2 System can be used in conjunction with the new VASOSHIELD Pressure Controlling Syringe, also recently introduced by MAQUET Cardiovascular. For a harvested artery or vein, the VASOSHIELD Pressure Controlling Syringe helps prevent overdistension during vessel preparation steps, thus protecting endothelial integrity. Uncontrolled pressure with a standard syringe may cause overdistension of the vessel prior to surgery, which can injure the endothelial lining of the vessel, potentially affecting long term patency results. Press release (.pdf)... Product page: Endoscopic Vessel Harvesting @ Maquet...... Michael

GE Healthcare has announced a joint venture with Intel Corporation, in which each company will reportedly hold a 50% stake. The new company will aim to provide quality of life improvements for patients who need to be closely monitored, such as seniors and those with chronic illnesses, through the implementation of technologies such as telemedicine. The name or headquarters location for the new company have not been announced. More from the press release: The venture builds on the GE-Intel healthcare alliance announced in April 2009 around independent living and chronic disease management. GE and Intel share a common vision to use technology to bring more effective healthcare into millions of homes and to improve the lives of seniors and people with chronic conditions. With the dramatic increase of people living with chronic conditions, and a global aging population, there is a need to find new models of healthcare delivery and extend care to the home and other residential settings. Once formed, the new company will develop and market products, services and technologies that promote healthy, independent living at home and in assisted living communities around the world. It will focus on three major segments: chronic disease management, independent living and assistive technologies. GE Healthcare and Intel will contribute assets in remote patient monitoring, independent living concepts and assistive technologies, such as the Intel® Health Guide, Intel® Reader and GE Healthcare’s QuietCare®. “New models of care delivery are required to address some of the largest issues facing society today, including our aging population, increasing healthcare costs and a large number of people living with chronic conditions,” said Intel President and CEO Paul Otellini. “We must rethink models of care that go beyond hospital and clinic visits, to home and community-based care models that allow for prevention, early detection, behavior change and social support. The creation of this new company is aimed at accelerating just that.” Link: GE, Intel to Form New Healthcare Joint Venture...... Smit

A few years behind radiology, the field of pathology is now slowly making the move to a digital working environment. One of the new tools helpful in automating some of the laborious tasks involved in pathological research is Definiens Tissue Studio, a digital pathology image analysis program for biomarker translational research. The program uses a "learn-by-example" principle, where it learns from example digital histopathology images with features identified by the user in order to automate measurement in other images. It can quantify localized biomarker expression as well as more than 50 morphological features within pre-defined regions of interest on a cell-by-cell basis and within sub-cellular compartments. The software can handle whole virtual slides as well as tissue micro arrays. The new 2.0 version adds full immunofluorescence support, improved nucleus detection for bright field images, customized “tuning” of Definiens Composer technology along with faster performance. Although it is aimed at research environments, we can see these kind of tools making headway into the clinical environment in the future as well, e.g. for quantifying Her2/neu expression in breast cancer. Press release: Definiens Tissue Studio 2.0 Supports Tumor Profiling, Multiplexing and Biomarker Translational Research... Product page: Tissue Studio...... Wouter Stomp

Researchers from Queen Mary, University of London and University of Twente have discovered that ceramic particles made of calcium phosphate act like signaling beacons to attract stem cells and growth factors to the site of an artificial bone graft. Calcium phosphate is the main ingredient of bone and it is hoped that it will be used as an alternative to autologous bone grafting. The researchers tested natural bone grafts against ceramic particles with varied structural and chemical properties. They found that micro-porous ceramic particles composed of calcium phosphate, the primary component of bone ash, induced stem cells to develop into bone cells in the test tube and stimulated bone growth in live tissue in mice, dogs and sheep. Bone injuries packed with the ceramic particles healed similarly to implants constructed from the animals' own bone, reports Professor de Bruijn along with collaborators from the University of Twente, Netherlands, in the journal Proceedings of the National Academy of Sciences. The study also shows how it also matches a commercially available product that contains artificial growth factors and has the undesirable side-effect of causing bone fragments to form in nearby soft tissue, such as muscle. Although the researchers have not yet identified the mechanism that drives bone growth in the synthetic implants, they note that variations in the ceramic material's chemistry, micro-porosity, micro-structure, and degradation influence the graft's performance. The study suggests that biomaterials-based bone grafts can manipulate cell behaviour in order to repair injury, and one day may be used to repair bone injuries in humans. Press release: Synthetic bone graft recruits stem cells for faster bone healing ... Abstract in PNAS: Osteoinductive ceramics as a synthetic alternative to autologous bone grafting... Michael

Researchers from Rochester University have created a hard plastic membrane, full of tiny holes, that can go between being permeable and impermeable to gas by shining light of different wavelengths. The holes in the membrane are filled with liquid crystals and a light reactive dye. When blue light is shined onto the dye, it lines up and the liquid crystals follow suit, creating a passage. When ultraviolet light is applied, the dye crinkles and so do the liquid crystals, blocking the hole. We can imagine drug dispensing devices that are stuck on or under the skin that can be easily switched on and off using a pocket light. Creating the membrane is a multi-step process. First, a circular hard plastic chip is bombarded with a beam of neutrons to make the tiny, evenly spaced holes that are about one-hundredth of a millimeter in diameter. The chip is then dipped in a solution of liquid crystals and dye, and the mixture fills the holes through capillary action. The final product is spun in a centrifuge to remove the excess liquid crystals from the surface. Controlling a membrane's permeability with light is preferable to controlling it with heat or electricity - two readily used alternative methods - for several reasons, Glowacki [Eric Glowacki, a graduate student at the University's Laboratory for Laser Energetics] said. For starters, light can operate remotely. Instead of attaching electrical lines to the membrane, a lamp or a laser can be directed at the membrane from a distance. This could allow engineers to make much smaller, simpler setups. Another advantage is that the color of the light illuminating the membrane can be changed precisely and almost instantaneously. Other methods, like heating and cooling, take a relatively long time and repeated heating and cooling can damage the membrane. Also, light does not have the potential to ignite a gas, which could be a crucial benefit when working with hydrocarbons or other flammable gases. Lastly, the amount of light energy needed to switch the membrane on and off is miniscule. Press release: Purple Light Means Go, Ultraviolet Light Means Stop ... (hat tip: io9)... Michael

RN Tara Summers was inspired to make an iPhone app after a frightening episode where she saw her infant child choking. Because she was a nurse, she sprang into action and gave the Heimlich maneuver, but worried about parents (or babysitters) without the same training. So, along with her emergency medicine physician husband, she created MedBasics -- a readily accessible information packet for the home about things to do in an emergency. Now, they're announcing an iPhone app called BabyMedBasics, for emergencies when you're not at home. More from MedBasics... iTunes Link to the iOS app...... Nicholas Nicholas

MicroVention, Inc. announced today the results of the HELPS trial, which compared the performance of its HydroCoil aneurysm treatment to that of traditional platinum coils. The study found that treatment with this new hydrogel-based system resulted in lower rates of recurrence and retreatment. The HydroCoil system utilizes an expandable hydrogel which swells up when it comes in contact with blood, thereby resulting in better filling of an aneurysm than treatment with a bare coil. Some results from the study: HydroCoil had more stable angiographic results with a significant decrease in major remnant/recurrence rates. The primary endpoint of reduction of major aneurysm remnant and recurrence, while neutral, showed a strong trend favoring HydroCoil. There was a very low overall retreatment rate of 3.5% (2.9% HydroCoil vs. 3.6% Bare Platinum). The effect of HydroCoil on major recurrence was superior in ruptured aneurysms and where increased filling by HydroCoil was achieved. There was a reduction of 20% in HydroCoil length used as compared to bare platinum. Because of HydroCoil's ability to expand into the aneurysm, there was higher packing density: 68.3% for HydroCoil and 24.9% for bare platinum. Press release: Final Data in International Trial Supports Safety and Effectiveness of MicroVention-Terumo's HydroCoil® Embolic System for Treatment of Cerebral Aneurysms... Product page: HydroCoil... Flashbacks: Medgadget hydrogel archives...... Smit

Gold Standard Diagnostics, Inc., a small company out of Davis, CA, just unveiled their Thunderbolt Automated Diagnostics Platform. The Thunderbolt is primarily an Enzyme Immunoassay (EIA) diagnostics tool, though it can be configured to perform chemiluminescence as well as multiplexing. Picture it as a customizable box with a fully programmable EIA processor that handles your samples and lets you customize it as you like. It seems like this is panning out to be Gold Standard Diagnostic's flagship product and they're keen to start showing it off. From the press release: The ThunderBolt platform will provide laboratory customers with a single hardware solution that can utilize multiple diagnostics technologies such as EIA, chemiluminescence and multiplexing. The inaugural product of the ThunderBolt platform is an EIA (enzyme immunoassay) processor, with a completely open software design capable of programming virtually any EIA test. EIA tests are widely used to detect and quantify substances such as peptides, proteins, antibodies and hormones, and to diagnose diseases and conditions including infections, cancer, metabolic disorders, allergies and autoimmune diseases. In a single, easily configured run, the flexible ThunderBolt EIA processor can process multiple microtiter plates, while also running up to eight different simultaneous assays. With an onboard reader, the fully automated EIA processor offers a true “walkaway” solution for labs of any size. The compact design takes up less than half the workspace of similar EIA automated processors on the market. Cost-effective operation makes the ThunderBolt suitable for larger clinical laboratories, while it also provides the customizable capabilities needed in hospital or research laboratories. Press release: Gold Standard Diagnostics Introduces the ThunderBolt Automated Diagnostics Platform... Product page: GSD Thunderbolt...... Sean Duffy www.medgadget.com

Tympanic membranes look out, Welch Allyn recently announced that their popular halogen otoscopes and opthalmoscopes are getting longer lasting LED replacements. The LEDs will last three times longer than their halogen counter parts per charge, giving doctors even more time to search for that elusive optic disk in their non-dilated patient before the battery runs out. Other features include a 30 times longer bulb life and SureColor technology, which keeps color output constant regardless of light intensity. The upgrades will be offered as a kit which includes a lamp, lamp removal tool and step-by-step instructions. From the press release: Cindy Kuiper, director of physical exam products North America, said “We are excited to offer caregivers our new LED replacement lamps and the opportunity to become more energy- and cost-efficient in their practices. The LED also removes the nuisance of having to deal with burned out lamps when trying to complete a physical exam. But the SureColor™ technology is what we’re most excited about. It allows the color of the light to remain the same even as the light intensity is dimmed, which is something practitioners will appreciate during an ophthalmic exam.” “The introduction of LED replacement lamps as a complement to our existing halogen lamp offering reaffirms our commitment to deliver new technologies that benefit the delivery of care,” added Kuiper. “It aligns with our strategic decision to focus on medical diagnostics, and we feel it is our responsibility to provide products that help control and reduce operating costs.” For their next upgrade may we suggest a feature that makes it so that toddlers don't think they are about to die when you are just trying to examine their ears. Press release: Welch Allyn Introduces Hassle-Free LED Replacement Lamps for Physical Assessment Instruments... jhbarad

WellDoc of Baltimore, MD won FDA clearance for its DiabetesManager System to be used by adults with type 2 diabetes in conjunction with their healthcare providers. The system aims to aid patients to adhere to proper diet and lifestyle in between visits to the doctor's office. From WellDoc's press release: The FDA has cleared WellDoc’s revolutionary mobile health (mHealth) System to offer automated clinical coaching and behavioral algorithms driven by real-time patient data. The software-based System supports patients and enables healthcare professionals to configure specific parameters and extend their care beyond traditional office visits by utilizing mobile phones and the Internet. The WellDoc System addresses a pressing need for innovative approaches to diabetes treatment. In development for more than five years, the DiabetesManager System supports medication adherence and securely provides for the capture, storage, and real-time transmission of blood glucose data and other diabetes self-management information. This information is then analyzed by the company’s proprietary Automated Expert Analytics System™, which identifies trends and then delivers relevant educational and behavioral patient coaching and provider decision support, thus enabling effective lifestyle and medication adjustments. Press release: FDA Clears WellDoc® DiabetesManager® System... Product page: WellDoc's Health Platform...... Michael

Wright Medical has released EVOLUTION, a new medial pivot knee replacement system. Like the company's ADVANCE knee, it features a ball-in-socket mechanism on the medial side that patients seem to prefer over traditional designs. This evening two hospitals, the St. Thomas Hospital in Nashville, Tennessee and St. Vincent Hospital in Little Rock, Arkansas, each will be doing a live webcast of the implantation and everyone is invited to participate. Inspired by this patient preference, Wright created the EVOLUTION(TM) Knee System to enhance its medial-pivot technology by offering more sizing options, improved instrumentation and a medial-pivoting posterior stabilized option. These enhancements were achieved through state-of-the-art engineering concepts and manufacturing technologies, including the use of CT-scans to produce implants which more accurately replicate natural knee anatomy, as well as features to aid in implantation through less-invasive surgical exposures. The resulting EVOLUTION(TM) Knee System is designed to ease rehabilitation and address stability concerns which may be experienced by some total knee replacement recipients. Video and links after the fold:... Michael

Bloomington, MN based ReSound has announced the launch of its new ReSound Alera wireless hearing aid, which uses Bluetooth to receive audio from a user's electronic devices. The company's Unite accessories connect to sources such as computers, cellphones, or even TVs, and wirelessly transmit audio from these sources to the hearing aid. From the press release: Operating on the 2.4 GHz frequency, ReSound Alera™ and the accompanying Unite™ wireless accessories introduce a new approach to the way a hearing aid receives sound from devices such as TVs, stereos, cell phones and computers. For the first time, the patient can receive sound directly from the device without cables, wires or the need to wear uncomfortable accessories. Because Alera™ uses 2.4 GHz wireless technology, it can be easily fitted without the use of a bulky device to connect the hearing aid to the fitting software. All that is needed is the AirLink fitting accessory, which is inserted into the USB port of a computer. This technology, though new to hearing aids, has been proven in the gaming industry and in the use of wireless keyboards. Press release: ReSound Announces Alera -- The First Truly Wireless Hearing Aid with No Strings Attached... Product pages: ReSound Alera...; ReSound Unite Accessories...... Smit

We are pleased to introduce two new channels on our HealCam free video chats site. Both channels will be for inflammatory bowel disease, one will be for UC and another one for Crohn's. Our big plan is to introduce a host of new options in the near future to cover more uncommon diseases, so people who don't necessarily have access to a support group in their vicinity will be able to do it through HealCam. So, please spread the word around if you know someone with IBD. And please stay tuned as we announce more and more channels. And if you have any suggestions, please use our contact form: we read all your inquiries.... Michael

A team led by Sandia National Laboratories researchers has developed a new manufacturing technique that puts a critical kink into the lumen of a nanopore. Due to their natural properties, nanopores, which are only slightly larger than DNA molecules, one day might be used to comprehensively characterize DNA, RNA, and proteins passing through. A consistent problem with nanopores has stemmed from the fact that DNA passes too quick through them, but a new technique of placing a kink inside the nanopores slows down the DNA passing through five fold. From a Sandia press release: Combined with atomic-layer deposition to modify the chemical characteristics of the nanopores, the innovations achieve a fivefold slowdown in the voltage-driven translocation speeds critically needed in DNA sequencing. “By control of pore size, length, shape and composition,” says lead researcher Jeff Brinker, “we capture the main functional behaviors of protein pores in our solid-state nanopore system.” The idea of using synthetic solid-state nanopores as single-molecule sensors for detection and characterization of DNA and its sister materials is currently under intensive investigation by researchers around the world. The thrust was inspired by the exquisite selectivity and flux demonstrated by natural biological channels. Researchers hope to emulate these behaviors by creating more robust synthetic materials more readily integrated into practical devices. Current scientific procedures align the formation of nominally cylindrical or conical pores at right angles to a membrane surface. These are less capable of significantly slowing the passage of DNA than the kinked nanopores. “We had a pretty simple idea,” Brinker says. “We use the self-assembly approaches we pioneered to make ultrathin membranes with ordered arrays of about 3-nanometer diameter pores. We then further tune the pore size via an atomic-layer deposition process we invented. This allows us to control the pore diameter and surface chemistry at the subnanometer scale. Compared to other solid state nanopores developed to date, our system combines finer control of pore size with the development of a kinked pore pathway. In combination, these allow slowing down the DNA velocity.” Link: Kinked nanopores slow DNA passage for easier sequencing... Abstract in Nature Materials: DNA translocation through an array of kinked nanopores... Michael

At UK's Portsmouth Hospitals Trust, clinicians have been test driving a digital pen system that works with Blackberry smartphones to record and transmit data entered on specialty paper. Here's a video we found via 3G Doctor demonstrating the system: This technology looks suspiciously similar to Shareable Ink that we covered at last year's TEDMED. More from 3G Doctor...... Michael

We'd like to remind our Spanish speaking readers to visit Medgadget Español, our new project to make Medgadget material available to more people. There might be up to half a billion Spanish speakers around the world, and we simply felt it wouldn't be right if they didn't have access to Medgadget in their mother tongue. Medgadget Español also has a complementary Facebook page and one in Twitter that you can subscribe to... Link: Medgadget Español (es.medgadget.com)... Michael

A team of IBM scientists used 410 anatomical tracing studies of the macaque brain to create what is possibly the most complete and complex map of the primate organ. The researchers report that their map has "383 hierarchically organized regions spanning cortex, thalamus, and basal ganglia; models the presence of 6,602 directed long-distance connections; is three times larger than any previously derived brain network; and contains subnetworks corresponding to classic corticocortical, corticosubcortical, and subcortico-subcortical fiber systems." We found that the empirical degree distribution of the network is consistent with the hypothesis of the maximum entropy exponential distribution and discovered two remarkable bridges between the brain's structure and function via network-theoretical analysis. First, prefrontal cortex contains a disproportionate share of topologically central regions. Second, there exists a tightly integrated core circuit, spanning parts of premotor cortex, prefrontal cortex, temporal lobe, parietal lobe, thalamus, basal ganglia, cingulate cortex, insula, and visual cortex, that includes much of the task-positive and task-negative networks and might play a special role in higher cognition and consciousness. More at KurzweilAI... Open access paper in PNAS: Network architecture of the long-distance pathways in the macaque brain... Michael

MediPurpose of Norcross, Georgia has released the babyLance, a new infant heel lancing device for taking blood test samples, usually done just after birth for blood glucose measurement, etc. The product comes in two lance depth sizes, 0.85 mm for preemies and 1.00 mm for newborns. Features from the press release: Ease of activation: Reduces trigger activation force, thereby significantly reducing the risk of bruising. Unique positioning design: Facilitates a stable and accurate placement against the targeted section of the infant's heel while ensuring the procedure can be performed consistently and quickly. Compliance with regulatory and quality standards: Manufactured to the same regulatory and quality standards as the SurgiLance® safety lancet, the babyLance™ cutting blade's swift pendulum action makes an incision that complies with the CLSI LA4-A5 established guidelines. Cost effectiveness: The babyLance™ heel incision device incorporates unique design characteristics that allow for the most cost-effective manufacturing process. Press release: MediPurpose Launches New babyLance Infant Heel Incision Device... Product page: babyLance...... Michael