Archives: 8/2006

From today’s announcement:

Medtronic, Inc., today announced the market introduction of its portfolio of fully automatic pacemakers, the Medtronic Adapta™, Versa™, and Sensia™ pacemakers. These pacing systems provide physiologic pacing adapted to the needs of individual patients, helping set new standards of care that reduce unnecessary pacing when the heart’s natural conduction is present. The portfolio recently received approval by the United States Food & Drug Administration…
The Adapta pacemaker offers the Medtronic-exclusive pacing mode called MVP™ or Managed Ventricular Pacing, which enables the device to be programmed to deliver pacing pulses to the heart’s lower right chamber (ventricle) only when necessary. MVP has been shown to reduce unnecessary right ventricular pacing by 99 percent (median value). Recent clinical studies have suggested that reducing this pacing stimulation may reduce the patient’s risk of developing heart failure and atrial fibrillation, a potentially life-threatening irregular heartbeat.
The new pacemaker systems also incorporate an array of automatic features to help physicians improve pacing therapy and streamline the patient follow-up process, potentially minimizing the amount of time spent in a physician’s office. The Adapta, Versa and Sensia pacemakers are completely automatic, and include the Medtronic-exclusive feature Atrial Capture Management (ACM). ACM is intended to automatically adjust impulses for optimal stimulation of the heart’s upper right chamber (atrium)…
The Adapta pacemaker portfolio, featuring algorithms clinically proven to effectively promote intrinsic conduction, is a key component of Medtronic’s Physiologic Pacing Program (MP3) initiative that illustrates where, when and how to best pace the heart. This comprehensive initiative helps educate physicians on recent clinical evidence about ventricular pacing and provides them with tailored solutions to either promote or mimic a patient’s normal cardiac function.

Medtronic’s website does not yet have product pages for these new devices.
The press release

Realistic%20Wounds Instructables: Realistic Wounds
For every medical student who has been ‘volunteered’ by their attending to participate in the ED’s mass casualty training, here is an excellent how-to on making realistic wounds. This is the first part in a series of fake injuries, so be sure to come back often!
Read more here. . .

645324ptam New Light Microscope with Insane ResolutionHoward Hughes Medical Institute’s investigators have developed and tested a new type of optical microscope. Offering resolutions of only 2 to 25 nanometers, the new microscopy technology is essentially not limited by the wavelength of the visible light:

The prototype for the new microscope was assembled in September 2005 in the living room of one of the inventors, Harald Hess, who will soon become director of the applied physics and instrumentation group at Janelia Farm. Hess collaborated on the project with colleague Eric Betzig, who is now a group leader at Janelia Farm. The assembly and underlying conceptual work on the microscope were personally funded with $25,000 each from Hess and Betzig…
Hess and Betzig had both thought a lot already about how to build a better microscope. In 1993, Betzig published a paper in Science showing that the position of fluorescent molecules under a near-field optical microscope can be identified with precision far greater than the wavelength of light was once thought to allow. And in 1994, in work that was also published in Science, Hess and Betzig showed together that the closely packed points light in a semiconductor could be individually isolated and studied. Combining these earlier studies, Betzig later proposed that molecular-level resolution might be achieved in cells by imaging just a few molecules at a time and identifying each one’s center – but no one yet knew how to separate out a cell’s densely packed proteins to make that possible under physiological conditions.
It was a tool developed in a biology lab that ultimately inspired the two physicists plan to build a better microscope. “In the world of biology there is a new generation of fluorescent proteins that you can switch on at will with a little bit of violet light,” Hess explained. He and Betzig learned of these molecules, which biologists can genetically link to cellular proteins that they wish to study, during conversations with Florida State University (FSU) scientist Michael Davidson in April 2005…
The basic concepts behind their new technique are simple: The researchers label the molecules they want to study with a photoactivatable probe, and then expose those molecules to a small amount of violet light. The light activates fluorescence in a small percentage of molecules, and the microscope captures an image of those that are turned on until they bleach. The process is repeated approximately 10,000 times, with each repetition capturing the position of a different subset of molecules.
Because the number of molecules captured in each image is small, they are far enough apart to see each molecule individually and thereby localize its center, Hess said. When a final image is created that includes the center of each individual molecule, it has a resolution previously only achievable with an electron microscope. Unlike electron microscopy, however, the new technique allows for more flexibility in labeling molecules of interest.
By early 2006, the collaborators were taking strikingly clear images of a number of cellular structures, including actin filaments, focal adhesion proteins, mitochondria, and the Golgi apparatus. “Performance-wise, it’s just astounding. And simplicity-wise it’s astounding,” Betzig said. “It knocks the socks off of standard fluorescence microscopy from a resolution perspective…”

Picture caption by HHMI: Resolution limitations of traditional optical microscopes lead to blurry images of small cellular components such as mitochondria (level 1). However, if specific proteins are tagged with fluorescent molecules that can be activated one-at-a-time (between levels 1 and 2), the positions of the molecules can be determined at a much finer level. The total position data is then assembled into an image (level 2) at a resolution comparable to an electron microscope (level 4), but with the added benefit of being specific to only the desired target protein.
LINK

4312541gn1 Leksell Gamma Knife® PERFEXION™ System
MTB Europe is reporting that Cromwell Hospital is the first institution in the UK to commission installation of Elekta’s new Leksell Gamma Knife® PERFEXION™ system for stereotactic radiosurgery in the brain, cervical spine, and head & neck regions. Elekta AB is a company based in Sweden. The system is quite a new one: only last month a patient from France was the first one to undergo a procedure with the device, according to a report.
Company’s punchlines about the system:

The revolutionary design of Leksell Gamma Knife® PERFEXION™ expands the treatment reach, offering a wider range of treatable anatomical structure. This expanded anatomical treatment area offers dramatic new opportunities to increase patient volume. According to statistics, up to 150 additional new patients per one million people will be suitable for procedures using Leksell Gamma Knife® PERFEXION™.
Always known for smooth workflow, Leksell Gamma Knife® PERFEXION™ makes the entire procedure more efficient and user-friendly. Collimator changes can be made by the control program in a matter of seconds, optimizing workflow and significantly reducing treatment time. Compared to previous Leksell Gamma Knife® systems, you save 30 minutes to one hour per patient. Multiply that by your patient load to see the number of days, and even weeks, you’ll save per year.

4312541gn2 Leksell Gamma Knife® PERFEXION™ System

Leksell Knife® PERFEXION™ provides the proven advantages of Gamma Knife® surgery coupled with enhanced features such as superior dosimetry performance that sets new standards in radiosurgery. The optimized design guarantees full backwards compatibility to existing Gamma Knife® surgery protocols and methods. The patented collimator design provides a virtually unlimited ability for sculpting the dose distribution, enabling dynamic shaping with absolute accuracy.
The new Leksell GammaPlan® PFX™ is as sophisticated as the system it controls, providing enhanced, user-friendly management of the advanced technology incorporated into Leksell Gamma Knife® PERFEXION™. The new shot dialog provides access to both composite shots and dynamic shaping. The client-based treatment planning system can be accessed remotely, providing instant access to all your patient data in the online database. To increase the seamless access, Leksell GammaPlan® PFX™ is now hosted on a PC platform with a Linux operating system.
Not only has Elekta created an instrument that takes radiosurgery to a new level of accuracy, precision and efficiency, there is no compromise in safety standards for staff or patients. Leksell Gamma Knife® PERFEXION™ shielding levels are 10 times better than alternative technologies. In fact the radiation leakage is so minimal, it is now possible to have windows between the treatment and control rooms.
The revolutionary Leksell Gamma Knife® PERFEXION™ system was designed and developed using the finest materials available. Throughout the system we have chosen state of the art industrial components with the best specifications. The sleek, sophisticated exterior design of Leksell Gamma Knife® PERFEXION™ encloses a technological marvel which performs with grace and precision. If you seek the ultimate in treatment efficacy and efficiency, you need Leksell Gamma Knife® PERFEXION™.

Product page

PPT88XXPP Hospital Food Ordering Goes WirelessAP-HP, a conglomerate of 40 hospitals with 23,000 beds in Ile-de-France, has chosen Symbol Technologies, Inc. to implement a computerized wireless food ordering system for its patients:

In April 2004, AP-HP, which groups together 38 healthcare establishments, invited tenders to implement robust and reliable technology for taking meal orders at patients’ bedsides. The solution had to adapt to the patient’s specific requirements, tastes and pathology, as well as automatically send the information to the kitchen to enable them to plan, order and prepare the meals. In addition, data traceability from the menus was essential. The solution proposed by Solutys, based on Symbol’s PPT8800 and MC50 mobile devices, met these needs and was chosen in October 2005. It will integrate order entry applications from Agfa Healthcare and Winrest.
Within the framework of its call for tenders, AP-HP wanted to ensure the longevity of the mobile devices in order to provide its users with a long-term solution. Moreover, given the difficult and intensive conditions under which the devices would be used, they had to be rugged in order to withstand numerous drops. To be certain of having a solid solution that would fulfill all the requirements of the hospital, AP-HP also added specific requests to its call for tenders. These included the provision of a disinfectable protective cover to meet the hygiene conditions inherent in a hospital environment, a stylus attached by a lead to the device to prevent it from being lost, and a strap so that the terminal could be carried securely across the chest…
A working group made up of dieticians, IT specialists and healthcare staff was set up to define the ideal solution. After analysing the needs and technical constraints, the devices had, most importantly, to be able to connect seamlessly to the network, to integrate into AP-HP’s existing system environment, to incorporate a barcode reader and be compatible with the meal order entry applications…
Each AP-HP location is able to choose between Symbol’s PPT8800 or MC50 mobile devices to meet their own specific requirements. The devices chosen will be integrated with Agfa Healthcare and Winrest order entry software. Both devices are sturdy, ergonomic and small in size, and are able to operate in batch mode and Wi-Fi allowing them to adapt to the infrastructure already in place. They both include a barcode reader for scanning the patient’s details in order to identify them in real-time.
“Symbol’s MC50 and PPT8800 mobile devices represent a reliable, rugged and comprehensive solution for users working in challenging environments,” states Nicolas Segons, country manager for Symbol Technologies France. “This deployment within AP-HP is a perfect example of how healthcare establishments can benefit from mobile technologies, enhance traceability and improve their performance.”

Press release
PPT8800 product page
(hat tip: MTB Europe)

43524234ww Pseudoscience Fridays: The Cause of CancerThat’s right ladies and gentlemen, we’ve found it. Forget what you’ve heard about chemical damage to cellular DNA, Dr Otto Walburg has arrived with great new info…

Cancer, above all other diseases, has countless secondary causes. Almost anything can cause cancer. But, even for cancer, there is only one prime cause. The prime cause of cancer is the replacement of the respiration of oxygen (oxidation of sugar) in normal body cells by fermentation of sugar.
All normal body cells meet their energy needs by respiration of oxygen, whereas cancer cells meet their energy needs in great part by fermentation. All normal body cells are thus obligate aerobes, whereas all cancer cells are partial anaerobes. From the standpoint of the physics and chemistry of life this difference between normal and cancer cells is so great that one can scarcely picture a greater difference. Oxygen gas, the donor of energy in plants and animals, is dethroned in the cancer cells and replaced by the energy yielding reaction of the lowest living forms, namely the fermentation of sugar.

Really…it has nothing to do with cell growth regulation? Okaaay…so based on this great information, how do we prevent cancer?

To prevent cancer it is therefore proposed first to keep the speed of the blood stream so high that the venous blood still contains sufficient oxygen; second, to keep high the concentration of hemoglobin in the blood; third, to add always to the food, even of healthy people, the active groups of the respiratory enzymes; and to increase the doses of these groups, if a precancerous state has already developed. If at the same time exogenous carcinogens are excluded rigorously, then much of the endogenous cancer may be prevented today.

We’ve tried to find a specific proposal for a mechanism to keep venous blood highly oxygenated or any speculation as to how to get arterial O2 saturations higher than the usual 90-something level. And, of course we were looking for a pile of relevant material published in credible journals, but, to be honest, it’s become too complicated to continue digging through the assorted “evidence” and other claims at alkalizeforhealth.net. Boy do they know how to write a disclaimer (emphasis ours):

The people responsible for this web site are not medical professionals. We publish the information on this web site as a public service. We assert our right of freedom of expression to take issue with the medical profession’s conflict of interest regarding cancer treatment and prevention. While we hope the information presented here is helpful, what you do with it is your responsibility.

By following along the assorted therapies listed in the sidebar or via the table of contents, you can really find a great repository of junk science.

An MIT-sponsored forum on vaccines as well as personalized medicines and CNS disorders will be held on August 17th (8:00am – 5:00pm) at MIT Stata Center. Free for all, but online reservation is required.

Collaborative Innovation in Action, a free, two-part biomedical innovation forum held at the Stata Center, will address a range of public policy, value chain, investment and research issues.
The afternoon program on personalized medicine will focus on emerging research relating to the central nervous system. Talks will offer perspectives on drug discovery and development; Food and Drug Administration regulation; the role of a standardized brain database in personalized medicine; and the clinical practice of personalized neurology and psychiatry.
The morning program on vaccines will offer in-depth case studies with important implications for society’s ability to respond to potential global pandemics such as avian flu and HIV, as well as bioterrorist attacks.

Register
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barcode Barcoded Medgadgets?
The FDA is thinking about a unique device identification system for the nation’s many medical implants and gadgets:

“Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients,” said Daniel Schultz, MD, director of the Center for Devices and Radiological Health at the FDA. “A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency.”
…The number and complexity of medical devices is growing. It is important for FDA to quickly identify new risks and work with industry and device users to manage these risks appropriately. A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.

We think this could also help with black-market recycled medical devices turning up on eBay or in your local OR…
The FDA is soliciting comments on this system.

conceptioncap Get Closer, with Conception Cap
It’s Friday! Time to concentrate on reproduction. And there’s no better way to do that than by putting on your Conception Caps! This FDA approved device apparently bypasses all the sperm-destroying aspects of lovemaking and physically puts semen as close to the uterus as possible:

“Sperm that are placed directly on the cervical opening with the Conception Cap do not have to deal with such issues as tilted cervix, high vaginal pH levels, being flushed out by gravity, low sperm count and low sperm motility,” he said…
Unlike older devices, the Conception Cap is made of flexible, surgical-grade silicone that women can use in the privacy of their homes. Previous caps were bulky, had to be inserted by a physician, and required women to lie in their doctor’s office for up to four hours. With the Conception Cap, women may continue normal activity while the cap is in place…
The Conception Kit has completed a clinical trial by Spectrum Health in Grand Rapids, Mich., that concluded that users are able to clearly understand its Instructions for Use and can follow them successfully.
The lead investigator of the trial is Dorsey Ligon, M.D., program director of the Spectrum Obstetrics and Gynecology Department. Dr. Ligon says that “successful use” means that users of the kit can understand and follow the Kit’s instructions, including being able to manipulate the semen collector, fill the Conception Cap and properly place the Cap onto the cervix without spilling the semen. The clinical trial also ensured that the user understands the warning labels, as well as the conditions that the Conception Kit will not overcome.
The Conception Kit contains everything a couple needs to greatly increase the chance of becoming pregnant over a three-month period – Conception Caps, non-latex semen collectors, ovulation predictors, conception timing wheels, pregnancy test kits, a medical provider note and envelope, an instruction manual, a journal to record progress and sperm-friendly intimate moisturizer samples.

And love. All for $299.95.
More from Conception Kit
Bonus: Dr. Dorsey Ligon, the study’s lead investigator and, quite coincidentally, chair of the Conceivex advisory board, has been in the news before