Archives: 10/2008

Wellex device Wellex Interspinous Process Medical Device Wins CE MarkThe EU has given green light to Eden Spine, out of Lake Mary, Florida, to market the company’s Wellex device, described by its inventor, Dr. Jean-Marc Fuentes, as a “compressible dynamic extension controller that not only relieves pain but also positively affects the long-term health of the segment through its ability to dynamically control extension while protecting and maintaining the neutral zone.”

Biomechanically, the Wellex maintains flexion, axial rotation and lateral bending but, more importantly, is not an extension blocker. Rather, it controls extension dynamically, thereby positively affecting the neutral zone and reducing disc and facet loading. Multi-level implantations are possible.
“The Wellex Interspinous Process Technology aims at perfecting the balance between motion and stability by restoring the posterior tension band, the facet congruence and the foraminal height,” explained Mourad Ben Mokhtar, head of Eden Spine’s research and developments efforts. “Its unique characteristics establish it as the latest generation of extension controllers, positioning it to be the gold standard for spinal patients who do not respond positively to conservative treatment, who are not willing to suffer the consequences of a fusion, and who are in need of pain relief from spinal stenosis.”

Press release: Eden Spine Receives CE Mark for its Nonfusion Wellex(TM) Interspinous Process Medical Device
Eden Spine company page

stemcell RED x220 Testicles May Be New Source of Stem CellsNew research has shown that testicles could be a new source for viable non-embryonic stem cells. The very thought of testicular biopsies, resonating through the editorial staff of Medgadget, calls for a continued search for other methods to obtain stem cells.

The new stem cells, known as human adult germline stem cells (GSCs), were grown by researchers in Germany and the U.K. by adding special growth factors to spermatogonial cells extracted from testes. Spermatogonial cells are stem cells in the adult testis that normally generate only one type of differentiated cell (sperm). But with the right growth factors, these spermatogonial cells can change to become pluripotent. They begin to produce proteins normally made by embryonic stem cells and acquire the ability to differentiate into many different cell types.
In a paper published today in Nature, Thomas Skutella of the University of Tubingen, in Germany, and his colleagues raise the possibility that adult GSCs could overcome many of the hurdles still facing alternative approaches.

More from MIT Technology Review
Image: Testicular transformation: Stem cells from adult human testes normally produce only sperm, but when cultured in the lab with special growth factors, they begin to resemble embryonic stem cells and can differentiate into many adult cell types. Credit: Thomas Skutella

250px Oceanites oceanicusPCCA20070623 3634B Storm petrel DNA Gives Clues to Cellular AgingAt Bucknell University Mark Haussmann has been studying the DNA of storm-petrels, seabirds that have unusually long lives.
From a Bucknell press release:

Mark Haussmann, an assistant professor of biology at Bucknell University, was interested in aging and why some animals live longer, healthier lives while others survive only a few years. Haussmann studied cacti and turtles before zeroing in on a small, marine bird that contradicts traditional assumptions about aging.
“Leach’s storm-petrels should die young but live a long life and break the conventional rules,” he said. “First of all, they’re small, and there tends to be a relationship between body size and life span. Elephants live longer than humans. Humans live longer than mice. So this bird shouldn’t live long, but it does.”
Haussmann, 33, stumbled upon some groundbreaking information in his work. His studies of storm-petrels have shown that certain characteristics of DNA – specifically lengths of the protective telomeres at the tips of DNA – are associated with species that live longer lives and possibly with how susceptible they are to cancer-causing tumors.
His work could be used as a springboard for drug companies studying cell division and cancer-treating drugs.

Full story: Sea birds’ DNA may hold keys to aging and cancer, researcher says…
Abstract: Telomeres and Longevity: Testing an Evolutionary Hypothesis Molecular Biology and Evolution, doi:10.1093/molbev/msm244
Image: Storm-petrel

webicina Webicina: Help for Doctors Entering 21st CenturyBertalan Meskó, one of the leading proponents of Health 2.0, and a former editor at Medgadget, has started a consultancy, called Webicina, for physicians to learn the benefits of online resources.
From Webicina:

The tools and services of web 2.0 can facilitate the work for medical professionals and help patients as well. If you would like an even more efficient medical practice; more productive research, pharma team; or you would like to know web 2.0 sites focusing on your medical condition, Medicine 2.0 Personalized Packages are created for you.
Medicine 2.0 Package is a personalized set of web 2.0 tools designed to solve your problems. If you would like to know which part of the web you should follow, which websites and services could be useful in your work, that is what Webicina can help you with.
The world is at your fingertips. If you would like to know

  • how to follow the medical papers of your field of interest more easily
  • how to create a medical blog
  • how to be up-to-date in your field and more productive in your practice,
  • Webicina’s E-Learning Tools are made for you. You tell us what your problems are with effectiveness and we provide the online materials and tutorials through which you can easily learn to use the tools and methods you need to improve your service or work.

    Link: Webicina
    More from Berci’s ScienceRoll

    helichopper device CDC to Get Population Movement Tracker for Disaster ResponseEngineers at Georgia Tech Research Institute are working on an aerial observation system, to be deployed on helicopters and small unmanned airplanes, that can monitor and relay to health officials the latest information about the population in an area after a natural disaster.

    The imaging system – designed by Price and senior research engineer Gary Gray – is called the “Mini ModPOD,” which stands for “Miniature Modular Photographic Observation Device.” It consists of an off-the-shelf Canon Digital Rebel XTi digital camera, a global positioning system receiver, a small circuit board that uploads mission parameters, and an inertial measurement unit that measures the aircraft’s rate of acceleration and changes in rotational attributes, including pitch, roll and yaw. The images collected from the system can be stitched together to create a complete picture of the affected area.
    The research team has tested the device on several flights, selecting areas with large populations of people likely to be outdoors.
    “During the first test flight, we wanted to test the clarity and resolution of the images collected during the run, and we were very pleased,” said Price. “We could see tennis balls on the ground and people reading books at outdoor tables. This was sufficient detail to allow accurate counting the number of people in an area.”
    After the first flight, the researchers reduced the weight of the device and developed a more accurate geo-referencing capability, which allowed the physical location of the scenes shown in each photograph to be determined with precision.

    Press release: Portable Imaging System Will Help Maximize Natural Disaster Response…

    pap acid Prostatic Acid Phosphatase May One Day Replace Morphine for Pain ControlUniversity of North Carolina at Chapel Hill School of Medicine and the University of Helsinki have collaborated on a project that identified prostatic acid phosphatase (PAP), as an excellent protein for pain suppression. The protein appears to be eight times more effective at suppressing pain than morphine.

    To study the transmission of painful signals throughout the body, many researchers use “marker” proteins that label pain-sensing neurons. One such marker, FRAP (fluoride-resistant acid phosphatase), has been employed for this purpose for nearly 50 years, but the gene that codes for its production was never identified.
    That is, until researchers at UNC found that FRAP is identical to PAP (prostatic acid phosphatase), a protein routinely used to diagnose prostate cancer whose levels increase in the blood of patients with metastatic prostate cancer.
    Previous research hinted that FRAP and PAP may have a shared identity. To determine whether or not this was the case, Zylka teamed up with Dr. Pirkko Vihko, a professor from the University of Helsinki who had genetically engineered mice that were missing the gene for PAP. When Zylka and his colleagues studied tissues from these mutant mice, they were happy to see that FRAP activity was missing. This revealed that the two proteins were in fact identical.
    Further, the mutant mice proved more sensitive than normal mice to inflammatory pain and neuropathic pain, two common forms of chronic pain in humans. These increased sensitivities diminished when researchers injected excess amounts of PAP into the spinal cords of the mutant mice.
    “We were really blown away that a simple injection could have such a potent effect on pain,” Zylka said. “Not only that, but it appeared to work much better than the commonly used drug morphine.”
    The new protein suppressed pain as effectively as morphine but for substantially longer. One dose of PAP lasted for up to three days, much longer than the five hours gained with a single dose of morphine.
    The next question for the researchers was how PAP suppressed pain. It is already known that when pain-sensing neurons are stimulated, they release chemicals known as nucleotides, specifically adenosine triphosphate (ATP). This in turn sets off the events that invoke a painful sensation. But if ATP degrades to adenosine, that inhibits the neurons that transmit pain signals, thus relieving pain. Through a series of experiments, the UNC researchers showed that PAP removes the phosphate group, generating adenosine.

    Press release: UNC study: cell protein suppresses pain eight times more effectively than morphine
    Image: Prostatic acid phosphatase

    nobel medicine Guess a Nobel Awards AnnouncementMedgadget would like to congratulate the winners of our first annual Guess-A-Nobel contest.
    Haruhiko Ishii, who works in a biology lab in the US, and is originally from Japan, named the three physics laureates with impressive gusto, and will soon be the recipient of a bright yellow iPod nano.
    Marc Zimmer is a chemistry professor at Connecticut College, and named all three of the chemistry laureates (out of five submitted names). He wrote a book about green fluorescent protein (GFP), the science of which led to this year’s Nobel in chemistry, and has a site devoted to the subject. Of course he chose a green colored iPod.

    98633tms Neuronetics TMS Depression Therapy Gets FDA OK
    Neuronetics, a Malvern, Pennsylvania company, has won FDA’s first approval for a transcranial magnetic stimulation (TMS) system for treatment of depression in patients that don’t respond to drug therapy. This is a huge step for a technology we’ve been following for many years now. Deep TMS devices are thought not only to help with depression, but one day might be indicated for schizophrenia, migranes, and restoration of peripheral vision for patients who are status post stroke.

    NeuroStar TMS Therapy® is specifically indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. In clinical trials with NeuroStar TMS Therapy, these patients had been treated with a median of 4 medication treatment attempts, one of which achieved criteria for adequate dose and duration.
    The NeuroStar TMS Therapy system is the first and only TMS Therapy® device cleared by the FDA for the treatment of depression. TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation which stimulates nerve cells in an area of the brain that is linked to depression, by delivering highly focused MRI-strength magnetic pulses. Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert. It is a 40-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist’s office. The treatment is typically administered daily for 4-6 weeks.
    98633tms2 Neuronetics TMS Depression Therapy Gets FDA OKClinical Trials Demonstrated Efficacy and Safety of NeuroStar TMS Therapy NeuroStar TMS Therapy was evaluated for efficacy, safety, and tolerability in the acute treatment of major depression in patients who had failed to receive benefit from prior antidepressant medications. A 6-week, randomized, placebo-controlled, double-blind, study1 was conducted to evaluate the safe and effective use of NeuroStar TMS as a monotherapy. An analysis for predictors of response demonstrated that the patients with the best response to NeuroStar TMS Therapy were those who had not benefited from one prior antidepressant medication at an adequate dose and duration in the current episode2. These are the patients for whom NeuroStar TMS Therapy has been cleared by the FDA.
    This clinical study population2 was comprised of 164 patients with unipolar, non-psychotic major depressive disorder. Almost all of them (97%) had suffered previous depression episodes. These patients also had an extensive treatment history without a satisfactory improvement. They had received a median of 4 total prior antidepressant treatment attempts in the current episode, one of which achieved treatment adequacy at or above the minimal effective dose and duration. Forty-eight percent were unemployed due to their depression, 35% had a co-morbid anxiety disorder, and all had moderate to severe depressive symptoms.

    In the indicated patient population, the following efficacy results were observed in the randomized, controlled study:

  • The primary efficacy measure, the Montgomery-Asberg Depression Rating Scale (MADRS) symptom score change at 4 weeks, was statistically significantly superior to placebo (p=0.0006), among NeuroStar-treated patients. Similar results were observed with the Hamilton Depression Rating Scale (HAMD) 3.
  • NeuroStar TMS Therapy-treated patients had statistically significant response3 and remission4 rates, which were approximately twice the rate of placebo-treated patients. The response rate is the percentage of patients who had a >50% improvement in symptoms, and the remission rate is the percentage of patients who achieved virtually complete symptom resolution.
  • NeuroStar TMS Therapy also produced statistically significant improvements on the HAMD factor scores for core depression symptoms, anxiety symptoms, somatization, and psychomotor retardation.4
  • Press release: FDA Clears NeuroStar® TMS Therapy for the Treatment of Depression, October 8, 2008 (PDF)
    Product page: NeuroStar TMS Therapy System
    Flashbacks: FDA to Consider Transcranial Magnetic Stimulation System , Deep TMS Technology by Brainsway, Transforming the Psychiatrist’s Office, and many other posts under Medgadget’s transcranial magnetic stimulation archive

    newrobosuit HAL, The One That Walks, Goes on SaleCyberdyne out of Tsukuba, Japan is making its power assist robosuit, dubbed Hybrid Assistive Limb (HAL), available as a rental to Japanese patients suffering from neuromuscular disorders, and to those who simply have difficulty walking.
    From a press release:

    The special suit was developed by Yoshiyuki Sankai, professor at the University of Tsukuba and Chief Executive Officer of Cyberdyne, the university’s spin-off firm.
    The suit, called Hybrid Assistive Limb, or HAL, aids wearers by detecting electrical signals on the skin that are sent from the brain to the muscles, and responding accordingly.
    The one- and two-legged models currently available are designed to help people with lower-body disabilities to walk.
    Cyberdyne also intends to commercialize a full-body model in April at the earliest that will enable the wearer to lift heavy objects or even people.

    5645er4 HAL, The One That Walks, Goes on SaleMore from the device page:

    When a person attempts to move, nerve signals are sent from the brain to the muscles via motoneuron, moving the musculoskeletal system as a consequence. At this moment, very weak biosignals can be detected on the surface of the skin. HAL catches these signals through a sensor attached on the skin of the wearer. Based on the signals obtained, the power unit is controlled to move the joint unitedly with the wearer’s muscle movement, enabling to support the wearer’s daily activities. This is what we call a ‘voluntary control system’ that provides movement interpreting the wearer’s intention from the biosignals in advance of the actual movement. Not only a ‘voluntary control system’ HAL has, but also a ‘robotic autonomous control system’ that provides human-like movement based on a robotic system which integrally work together with the ‘autonomous control system’. HAL is the world’s first cyborg-type robot controlled by this unique Hybrid System.

    Press release: Cyberdyne, Daiwa House to Lease Assistive Robotic Suit
    Product page: Robot Suit HAL
    Flashbacks: Robo Suit Helps Quadriplegic; HAL 3