Archives: 1/2008

devices ensite voltage map St. Jude Medical Gets FDA OK for Cardiac Image Integration Software
EnSite Fusion™ Registration Module, a newly approved software system for arrhythmia imaging and electrophysiology catheter navigation from St. Jude Medical, is touted to integrate computed tomography data with the company’s EnSite System, for better 3D anatomical presentation during procedures.

St. Jude Medical’s EnSite Fusion software registers, or integrates, an EnSite System-created chamber model with a three-dimensional computed tomography (CT) model so that the physician has an improved view of the heart’s anatomy to better guide the delivery of therapy.
EnSite Fusion is the first and only tool with the capability for “dynamic registration,” which allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a more detailed image of the heart. Dynamic registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3-D, CT model.
EnSite Fusion also displays electrical information such as voltage, activation timing and lesion data directly on the CT model. In addition, EnSite Fusion provides the flexibility to transition quickly between the fused model and the original EnSite model throughout the procedure, helping clinicians optimize the view to best meet the specific demands of the procedure.
“The models produced by EnSite Fusion result in better, faster care for my patients and more reliable delivery of therapy for complex arrhythmias, such as atrial fibrillation,” said Andrea Natale, M.D., who is a consulting professor at Stanford University and practicing at California Pacific Medical Center. “Because each heart is different, having a tool that helps guide the direction of the therapy through the detailed models is of great value to me.”
The EnSite System is used in minimally invasive electrophysiology procedures. Catheters with electrodes are inserted into the cardiac chamber and then are located or “sensed” by the EnSite System, which records electrical information and creates a rendering of the chamber anatomy.

St. Jude Medical will feature its EnSite Fusion at the Boston Atrial Fibrillation Symposium, which starts tomorrow.
Press release: St. Jude Medical Announces U.S. Clearance for Cardiac Image Integration Software
EnSite® System product page…

evicel package device 110807 Evicel Fibrin Sealant Approved for Control of Surgical Bleeding
Evicel™, a fibrin glue manufactured by OMRIX Biopharmaceuticals LTD, in Kiryat Ono, Israel, has received a new indication from the FDA for use for general hemostasis in surgery.

The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.
“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated.
A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.
FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.

FDA press release: FDA Approves Sealant to Control Bleeding During Surgery…
Omrix press release: OMRIX Biopharmaceuticals Receives FDA Approval for General Hemostasis in Surgery Indication for EVICEL(TM) Liquid Fibrin Sealant (Human) …
Product page: Evicel™ …

farmer exosteleton Gardeners ExoskeletonTokyo University of Agriculture and Technology is actually developing an exoskeleton for aging gardeners.

The “farming robot suit,” developed by a team of researchers led by Shigeki Toyama, a professor in the graduate school of the Tokyo University of Agriculture and Technology, has been tested on farms. Researchers hope to have the technology in use in 2 years and develop it into a product and begin selling it in four years.
The suit, which is secured with belts, consists of a resin framework with eight motors to assist the movements of the knees, elbows, lower back and shoulders, making farm work easier.
When pulling out a Japanese radish, for example, about 20 kilograms of instantaneous pressure is exerted on the knees and lower back, but when using the robot suit, only about half the force is used.

So what’s the next technology on the horizon? In our humble opinion, full body shield for bonsai masters.
More at Mainichi Daily News

image enhancement Higher Contrast for Better ViewingResearchers at Schepens Eye Research Institute at Harvard are working on software for digital televisions that will let them produce a higher contrast picture specifically for the visually impaired.

Working within the “decoder” that makes digital television images possible, Peli and his colleagues were able to make a simple change that could give every digital TV the contrast enhancing potential for the benefit of the visually impaired. “The same modification could easily be made to new HDTVs, and digital cable set top boxes,” says Matthew Fullerton, the paper’s first author, and a student of electronic engineering from the University of York in England who is currently working on his Master’s degree in Peli’s lab.
To test their new technology, the team presented eight digital videos to 24 subjects with vision impairment and six with normal vision. Each patient was given a remote control, which allowed him/her to increase or decrease the contrast of the image. Patients manipulated over-enhanced and blurry images for the greatest clarity.
The research team learned that even subjects with normal sight selected some enhancement and that the amount of enhancement selected by those with visual problems varied depending upon the level of contrast sensitivity loss they experienced due to their disease. All this demonstrated to the team that the device was both usable and useful to the subjects, even those without vision problems.
Peli is now working with Analog Devices Inc. to create a prototype chip that could be included in all future generations of digital television. “The technology we created is quite simple and can easily and cheaply be incorporated into even the newest technologies for television and internet video.”

Study page at Schepens Eye Research Institute…
Video enhancement example videos
Press release: Technique Enhances Digital Television Viewing for Visually Impaired …

Ivanhoe, a producer of health and medical videos for TV news channels, has opened up an online site that will feature longer excerpts than on TV of surgical procedures. Currently there are videos on eyelash transplantation and regrowing of poorly developed fingers.
Ivanhoe Surgery Channel
(hat tip: Broadcast Newsroom)

touch the invisible sky%20%28300%20x%20375%29 NASA Astronomy Book for the BlindIn what some may think is a strange move, NASA just published photo astronomy book for the blind. Using surface texture, the book lets the blind experience the universe, all while reminding the rest of us that visible light is only a tiny spectrum of what telescopes can see.

“Touch the Invisible Sky” is a 60-page book with color images of nebulae, stars, galaxies and some of the telescopes that captured the original pictures. Each image is embossed with lines, bumps and other textures. These raised patterns translate colors, shapes and other intricate details of the cosmic objects, allowing visually impaired people to experience them. Braille and large-print descriptions accompany each of the book’s 28 photographs, making the book’s design accessible to readers of all visual abilities.
The book contains spectacular images from the Great Observatories and powerful ground-based telescopes. The celestial objects are presented as they appear through visible-light telescopes and different spectral regions invisible to the naked eye, from radio to infrared, visible, ultraviolet and X-ray light.
The book introduces the concept of light and the spectrum and explains how the different observatories complement each others’ findings. Readers take a cosmic journey beginning with images of the sun, and travel out into the galaxy to visit relics of exploding and dying stars, as well as the Whirlpool galaxy and colliding Antennae galaxies.

Press release: NASA Unveils Cosmic Images Book in Braille for Blind Readers
More from Science@NASA

gloveSM Rubber Surgical Gloves: Invented and Disinvented at HopkinsWilliam Stewart Halsted, Johns Hopkins Hospital’s first head surgeon, invented rubber surgical gloves, and now the very same institution has instituted a moratorium on them.

It was at Hopkins that immunologists Robert Hamilton, Ph.D., and Franklin Adkinson, M.D., conducted early key research related to the problems of natural rubber latex as an allergen. Furthermore, Brown points out, the nurses and other frontline hospital workers have been instrumental in implementing the latex-safe policy and educating the staff. Studies show that roughly 6 percent of the general population and up to 15 percent of health care works are allergic to latex, with the higher rate among medical personnel due to longer periods of contact with natural rubber. In addition to surgical gloves, latex is used in numerous medical devices such as tourniquets, blood pressure cuffs and stethoscope tubes. The anaphylactic reactions, similar to those caused by foods such as peanuts or by bee sting allergies, can include a drop in blood pressure, an irregular heartbeat, swelling in the hands and feet and constriction of the airways. In extreme cases, anaphylactic shock, which can occur minutes after the exposure, can lead to death.
Allergic reactions generally result from exposure to natural proteins, in this case proteins specific to natural rubber latex, a product from rubber trees.
Currently available replacement gloves are made of one of three synthetic products — neoprene, polyisoprene or vinyl, none of which contain natural plant proteins.
Johns Hopkins is now using sterile neoprene and polyisoprene gloves in the operating room because they have a more sensitive feel.

Press release: RUBBER GLOVES: “BORN” – AND NOW BANISHED – AT JOHNS HOPKINS
Podcast from Johns Hopkins on the transition to latex-free…

 Manipulating Cellular Signaling with Magnetic FieldsInvestigators at Children’s Hospital Boston, in collaboration with physicists at Harvard University, developed nanobeads, particles only 30 nanometers in diameter, that, once attached to receptor molecules on the surface of a cell, were able to stimulate intracellular processes by “sensing” an external magnetic field.

When exposed to a magnetic field, the beads themselves become magnets, and pull together through magnetic attraction. This pull drags the cell’s receptors into large clusters, mimicking what happens when drugs or other molecules bind to them. This clustering, in turn, activates the receptors, triggering a cascade of biochemical signals that influence different cell functions.
The technology could lead to non-invasive ways of controlling drug release or physiologic processes such as heart rhythms and muscle contractions, says Ingber, the study’s senior investigator.
In a demonstration involving mast cells (a kind of cell in the immune system), Ingber and Mannix [Don Ingber, MD, PhD, and Robert Mannix, PhD, of program in Vascular Biology at Children's Hospital Boston --ed.]showed that the beads, when bound to cell receptors and exposed to a magnetic field, were able to stimulate an influx of calcium into the cells. (Calcium influx is a fundamental signal used by nerve cells to initiate nerve conduction, by heart and muscle cells to stimulate contractions and by other cells for secretion.) Magnetic fields alone, without the beads, had no effect.
The beads–30-nm size (with an inner 5-nm particle) provides the optimal crystal geometry to make them “superparamagnetic”–able to be magnetized and demagnetized over and over, notes Mannix, who shares first authorship of the paper with Sanjay Kumar, MD, PhD of Children’s. (Kumar is now a faculty member in Bioengineering at the University of California at Berkeley.) To give a sense of scale, one nanometer is to a meter (about a yard) as one blueberry is to the diameter of the Earth.
The beads were made to attach to the mast-cell receptors by pre-coating them with antigens; these antigens then bound to antibodies that coated the receptors, similar to the way antibodies bind to antigens in the immune system. “Our goal was to have one antigen coating each bead, so that each bead would bind to just one receptor,” Mannix says.

Press release: An “attractive” man-machine interface …
Abstract in Nature Nanotechnology

frost2008mindxchange Medical Devices 2008 Executive MindXchange

Frost & Sullivan, one of the leaders in medical technology consulting, will be hosting in March its 13th annual Medical Devices Executive MindXchange in San Francisco. Aiming to bring together business leaders in the field that will share business practices, discuss industry developments, develop partnerships, and consider future changes and strategies, Frost & Sullivan is inviting those interested to register for the event.
Medgadget editors attended previous Medical Device MindXchange conferences, and because of the quality of the program we plan on doing so this year.
Frost & Sullivan Medical Devices 2008 Executive MindXchange information page…
Conference brochure and agenda (PDF)…