Tuesday, May 13, 2008
Synergy Pocket Circulatory Assist Device Does Well in Early Trial
Filed under: Cardiac Surgery
The Synergy Pocket Circulatory Assist device from Circulite, a company out of Saddle Brook, New Jersey and Aachen, Germany, is doing well in a European clinical trial, according to the MIT Tech Review.
According to the magazine, the device, first covered by us in Aug 2007, has been implanted in nine patients, all of them still alive and apparently doing well. Of these patients, five have successfully gone on to heart transplants, showing the device to be a potentially useful modality as a bridge to transplantation.
A quick refresher on the technology:
... the Synergy Pocket Circulatory Assist device combines a superficially positioned micro-pump with inflow and outflow cannulae placed with endovascular techniques. Blood is drawn from the Left Atrium via the Inflow Cannula that is connected to the micro-pump which pumps the blood back to the body via the Outflow Graft to the Subclavian Artery...The Synergy Pocket Circulatory Assist device works in synergy with the patient's native heart function and pumps up to 3 liters of blood per minute (partial circulatory assist) to increase the total cardiac output (blood to body).
The hemodynamic effects of partial circulatory assist were assessed in a computer-based heart failure simulation model which predicts partial circulatory assist of 2 to 3 liter of blood flow per minute:
Decreases left ventricular end diastolic pressure by 7 to 10 mm Hg
Provides significant pressure and volume unloading of the native heart
Increases net cardiac output by ~ 1 liter of blood flow per minute The hemodynamic effects of partial circulatory assist have also been reported in a small, single center study. Twenty patients supported on HeartMate™ VE Ventricular Assist Device (VAD), were assessed on full assist (approximately 5 liters of blood flow per minute) and partial assist (approximately 1.6 liters of blood flow per minute) which was achieved by reducing the device's cycles per minutes setting. The authors concluded that partial circulatory assist:
Improved peak VO2 consumption
Improved myocardial function ...Synergy device micro-pump has been refined to be the smallest implantable blood pump and has several unique features that are designed to minimize the risk of thrombus formation and hemolysis.
The Synergy device micro-pump combines axial, centrifugal and orthogonal flow paths with a single-stage impeller that is powered by an integrated brushless micro-electric motor. The micro-pump is the size of a AA battery with an outer body diameter of 14 mm, length of 49 mm, weight of 25 grams and pumps up to 3 liters of blood per minute.
The Synergy device micro-pump design features a unique magnetically and hydrodynamically levitated and stabilized impeller design. The design allows the motor to be sealed thus eliminating blood contact in the motor and the potential of thrombosis formation. The micro-pump also features a proprietary self-washing flow path that minimizes the risk of thrombus formation in or around the impeller.
Product page: Synergy Pocket Circulatory Assist...
Technology Review: Tiny Blood Pumps for Failing Hearts...
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Monday, May 12, 2008
Microsoft Envisions Smarter EMR Interfaces
Filed under: Informatics
Microsoft engineers are working on developing visual interfaces for electronic medical records (EMR), and have setup a website to help with brainstorming and demonstrating different ideas using Microsoft's Common User Interface platform powered by Silverlight, the company's high powered version of Adobe Flash.
From Microsoft Health's Patient Journey Demonstrator:
The Patient Journey Demonstrator conceptualizes an end-to-end journey where a specific clinical scenario is used to illustrate how an integrated, patient-centric care record can transition seamlessly between care settings. It demonstrates how data can be accessed and entered from many of the care sources experienced along the patient journey.In this scenario, a man with suspected heart disease is examined by his family doctor. Using decision support tools, his doctor decides that the best course of action is to refer him for further tests. The scenario then tracks the activities that take place from the initial consultation through secondary care to an Angiogram.
Link: Patient Journey Demonstrator
(hat tip: Medgadget reader Thomas A.)
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Ins and Outs
Filed under:
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OraVerse, Dental Anesthestic Reversal, Gets FDA OK
Filed under: Dentistry
This is not about a device, but rather the first pharmaceutical agent in a new class. Novalar Pharmaceuticals, Inc., a private San Diego, CA firm, is reporting that its proprietary phentolamine mesylate formulation (OraVerse™, formerly known as NV-101) has received FDA approval for the "reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic." Pictured above is the current theory on how the drug works, as no one seems to know about the exact biochemical mechanism behind the drug's action.
From the press release:
OraVerse’s approval for use in adults and children is based on data from several clinical studies, including two Phase 3 studies in adults and adolescents age 12 and older and a Phase 2 pediatric study. The two Phase 3 studies were conducted in 18 centers across the United States, including leading dental schools, clinical research organizations and private clinics. There were 484 dental patients enrolled across the two studies.In the randomized, double-blinded, controlled Phase 3 studies, following the administration of local anesthetics and completion of the dental procedure, patients were administered either OraVerse or control. OraVerse reduced the median time to recovery of normal sensation in the lower lip (as measured by standardized lip tapping procedures) by 85 minutes compared to control. OraVerse reduced the median time to recovery of normal sensation in the upper lip by 83 minutes. Within one hour after administration of OraVerse, 41% of patients reported normal lower lip sensation as compared to 7% in the control group, and 59% of patients in the OraVerse group reported normal upper lip sensation as compared to 12% in the control group. In both Phase 3 studies, the primary endpoint showed that OraVerse was statistically different compared to control (p<0.0001).
The multi-center, randomized, double-blinded, controlled Phase 2 pediatric study evaluated the safety and efficacy of OraVerse in the reversal of soft tissue anesthesia in patients undergoing dental procedures after receiving local anesthetic. This study enrolled 152 patients: 96 patients in the OraVerse group and 56 patients in the control group. Of the 152 patients enrolled, 115 were trainable in the assessment method: 72 patients in the OraVerse group and 43 patients in the control group. The study assessed OraVerse’s efficacy through the measurement of time to normal lip sensation for those trainable in the assessment. The median time to normal sensation in patients age 6-11 was reduced by 75 minutes for the OraVerse treated group, a 56% acceleration of the time to normal sensation.
In all OraVerse clinical trials, there were no serious adverse events reported and the most common adverse reaction that was greater than control was transient injection site pain. Although tachycardia and cardiac arrhythmia may occur with the parenteral use of alpha-adrenergic blocking agents, such events are uncommon after submucosal administration of OraVerse.
Product page: NV-101...
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MEMENTO Memory LifeBook Concept
Filed under: Geriatrics
, Neurology
, Psychiatry
, Rehab
Peter Sin Guili, a product design student at LaSalle-SIA College of the Arts in Singapore, tells Medgadget that he has developed an idea for a personal assistance device to help people suffering from dementia, which can help with communication, memorizing events in one's life, and keeping tabs on important to-do's and objects that need to be kept in mind.
More about the device:
MEMENTO Memory LifeBook is designed as a "wearable mobile product solution" to serve as a multi-faceted holistic mobile memory aid device as well as providing a security safeguard for elderly individuals with mild-to-moderate dementia. The User-Centered design approach and ergonomic studies are undertaken to devise a product which is effective and meeting the needs and concerns of the target users. The product aims to allow the elderly demented users manage their lives more effectively and efficiently by providing them with the confidence and ability to carry on their day-to-day living independently as normal as possible and for as long as possible by rendering cognitive assistance in various spheres: e.g. maintaining contacts, reminiscence, effecting everyday routine tasks, keeping track of appointments, and keeping close to medication routines among others.
More info on the MEMENTO here...
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Blow Up Love Dolls Recruited in Fight Against Genital Mutilation
Filed under: in the news...
The Association of Women Against Genital Mutilation is using blow up plastic dolls in its ads, created by a Spanish firm Contrapunto BBDO, to make a provocative statement to help stop the practice around the world.
(hat tip: BoingBoing)
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Micro-Gel Drops on a Slide Have Huge Promise
Filed under: Diagnostics
Argonne National Laboratory is reporting that its microarray molecular identification technology (aka "mini-secondary ELISA's"), which features a highly porous polymer matrix for enhanced interaction of molecules with antibodies, has promise in the search for biomarkers for a variety of cancers and other illnesses:
The new technology, known as a biochip, consists of a one-centimeter by one centimeter array that comprises anywhere between several dozen and several hundred "dots," or small drops. Each of these drops contains a unique protein, antibody or nucleic acid that will attach to a particular DNA sequence or antigen.A tumor, even in its earliest asymptomatic phases, can slough off proteins that find their way into a patient's circulatory system. These proteins trigger the immune system to kick into gear, producing antibodies that regulate which proteins belong and which do not.
"Antibodies are the guardians of what goes on in the body," said Tim Barder, president of Eprogen, Inc., which has licensed Argonne's biochip technology to search for new biomarkers that indicate cancer. "If a cancer cell produces aberrant proteins, then it's very likely that the patient will have an antibody profile that differs from that of a healthy person. You can look for similarities and differences in autoantibody profiles to look for clues and markers that provide early indicators of disease."
In their hunt for cancer indicators, Eprogen uses a process called 2-dimesional protein fractionation, which sorts thousands of different proteins from cancer cells by both their electrical charge and their hydrophobicity or "stickiness."
The 2-D fractionation process creates 960 separate protein fractions, which are then arranged in a single biochip containing 96-well grids. Eprogen scientists then probe the microarrays with known serum or plasma "auto-antibodies" produced by the immune systems of cancer patients.
By using cancer patients' own auto-antibodies as a diagnostic tool, doctors could potentially tailor treatments based on their personal autoantibody profile. "This technology is really designed to take advantage of the information contained within the patient's own biology," Barder said. "What makes this technique unique is that scientists can use the actual expression of the patient's disease as a means of obtaining new and better diagnostic information that doctors could use to understand and fight cancer better.
"We're starting to see a way of developing tests and therapies for cancer by bringing the bedside to the laboratory, rather than the other way around," he added.
Biochips have already shown promise in diagnostic medicine, according to Argonne biologist Daniel Schabacker, who developed the technology. In addition to Eprogen, three other companies have licensed biochips, he said. One of these companies, Akonni Biosystems of Frederick, Md., has already produced dozens of assays, which it markets under the TruArray® brand name. Another company, Safeguard Biosystems, licensed biochips for veterinary diagnostic applications.
When a biochip tailored to detect upper respiratory diseases is exposed to a swab taken from a patient's mouth, for instance, the binding patterns of the proteins or nucleic acids in the array cause the dots to "light up" when scanned and analyzed with a computer. Computer algorithms decode the dot pattern produced by the biochip, calculate the statistical likelihood of each possible infection and provide this information to the doctor.
"Suppose someone shows up to the hospital and they're sick with an upper respiratory infection," said Schabacker. "First thing a doctor is going to want to know is whether the infection is viral or bacterial; this is especially true in pediatrics. And ideally, they'd really like to have a single test that they can run very rapidly that will identify exactly which disease you have from a dozen top targets."
The development of products like TruArray will soon revolutionize doctors' ability to quickly diagnose a number of diseases, Schabacker said. For example, while existing rapid strep tests performed by many pediatricians take only a few minutes to process, they yield so many false negatives that doctors routinely send out the samples for subsequent rounds of more thorough, time-consuming and expensive analysis.
"The unique advantage offered by the TruArray platform lies in the fact that we can screen a single sample for multiple viral and bacterial infections at the same time," said Charles Daitch, Akonni's president and CEO. "Soon, doctors will no longer need to order as many expensive and time-consuming tests, and can instead obtain accurate diagnoses that will enable them to quickly provide their patients with targeted treatment strategies."
Though the analysis of a sample on a biochip can take 30 minutes, scientists can have much more confidence in the accuracy of the diagnosis, according to Schabacker. "Biochips give us the ability to run a test that allows your doctor to figure out exactly what you're suffering from during the time that you're in his or her office," he said.
While biochips will allow doctors to more quickly and authoritatively explain your sniffles, they might also be used for patients who exhibit symptoms of much more serious infections. By adding just a few more drops to the chip's array, Schabacker claimed, lab technicians could test for a whole slate of biotoxins and especially virulent diseases from the plague to smallpox to anthrax.
Other infections, such as those caused by Multidrug-Resistant Tuberculosis (MDR-TB) and the often deadly Methicillin-resistant Staphylococcus aureus (MRSA), can be quickly diagnosed with biochips like Akonni's TruArray assay, according to Daitch.
Press release: Biochips can detect cancers before symptoms develop...
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Anaglyphs of Anatomical Waxworks by Clemente Susini in 3D, on Flickr
Filed under: Art
Joanna Ebenstein over at Morbid Anatomy writes:
Grab your red/blue 3D glasses and head over to Flickr to check out a few of master wax-worker Clemente Susini's (1757-1814) anatomical waxes in 3D (!!!), compliments of Stanford Medicine's newly released series of anaglyphs. Robert Chase, MD, along with a team of many others, have produced 3D stereo photos of Susini waxes held at the Museo delle Cere Anatomiche Luigi Cattaneo and made 6 of them available for public perusal on their Flickr page. This is a curious development; it adds to Stanford Medical School's already rich and idiosyncratic Flickr collection, and suggests to me that they might be trying to produce a series of "classic 3D anatomy" products, perhaps to compete with the virtual 3D anatomy software packages dominating the contemporary educational market.
Theses 6 images, taken in 2007, mark the launch of a larger program (that will include, one supposes, many more images to be made available, and at a cost) and will be launched later this year. The purported goal of the project is to"bring these waxworks to a larger audience that includes medical students and art enthusiasts alike."
More at Morbid Anatomy...
Link to the project page...
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Real Doctors, Real Patients, Virtual Office
Filed under: Net News
The Spanish Society for Family and Community Medicine (FYC) and the Coalition for Citizens with Chronic Illnesses has setup a service for Spanish teenagers to virtually visit a real doctor in Second Life, the 3D online virtual world. The goal is to provide a space where embarrassing issues can be raised in privacy, without the blushing of a face to face consultation.
Real doctors will log on and offer advice to their anonymous patients. What both will see is an image of a consulting room with a doctor and a typical patient.Dr Rosario Jimènez, of the Adolescent Attention Working Group, is one of the doctors who will spend up to four hours a week answering their virtual patients' questions.
She said: "Teenagers do not often go to see the doctor but this is an efficient and amusing tool to reach them because we can both use the same route. Even though they do not often suffer serious illnesses, they often expose themselves to risks which can develop into problems in the future.
"This is a way to talk about their doubts about taking drugs or sexual relations which they cannot do in a traditional consultation."
More at The Guardian...
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Cell Phone Network for Ghana's Doctors
Filed under: in the news...
Our good friend, and former Medgadget editor, Brian Levine has been working on a project in Ghana to create a cell phone network for physicians. The system provides an easy way for doctors to refer patients to specialists, access to each other's knowledge base for consultation on clinical questions, and a way for patients to locate and communicate with their doctors. Originally started as an online tool, it was quickly realized that access to communication technology of any sort is the fundamental problem in Ghana. Brian had to change course, and partnered with a Ghanan mobile provider to put the pieces together. The project required some smart thinking to overcome local issues, such as cost, locating and communicating with physicians, and bringing everyone onto the same network. The project already boasts a registration of 1500 out of 2000 of Ghana's doctors, and they are actively using the system as intended, helping the much needed country's doctors to be more effective in their practices.
More from VOA News...
Listen to an interview with Brian Levine (mp3) on Public Radio International's The World (segment begins at 10:35)...
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David Feldman on Risks of Bisphenol A
Filed under: Public Health
David Feldman, MD, emeritus professor of endocrinology at Stanford, and his team were the first researchers to identify and warn about possible effects of low levels of bisphenol A (BPA) on human health. BPA has been increasingly seen in the news lately, with Wal-Mart and Nalgene moving away from the chemical used in many household plastics, as well as Canada leaning toward declaring the chemical a dangerous substance. The Stanford University School of Medicine has just published a short interview with Dr. Feldman about the accidental discovery, and we would like to recommend that interview to our readers: Stanford Q&A: David Feldman on risk of bisphenol A in plastic bottles...
The image is taken from a page at Rubbermaid: Rubbermaid food storage & beverage products that contain BPA
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Friday, May 9, 2008
Solve Puzzles for Science: Fold It!
Filed under: Net News
This new online game, a protein folding puzzler, is a product of a collaboration between scientists at University of Washington and Howard Hughes Medical Institute. The game is designed to entertain and advance science at the same time. In other words, this is a distributed computing project with built-in fun.
...Howard Hughes Medical Institute (HHMI) researchers at the University of Washington are bringing the arcane world of protein folding to the online gaming arena with the launch of “Foldit,” a free game in which players around the world compete to design proteins. The real world benefit: Scientists will test proteins designed by the game's players to see if they make viable candidate compounds for new drugs.Users can access the game via the web at www.fold.it
The development of the online game is a natural extension of HHMI investigator David Baker's quest to understand how proteins - the building blocks of cells — fold into unique three-dimensional shapes. Over the past decade, Baker and his colleagues have made steady progress in developing computer algorithms to predict how a linear string of amino acids will fold into a given protein's characteristic shape. A detailed understanding of a protein's structure can offer scientists a wealth of information — revealing intricacies about the protein's biological function and suggesting new ideas for drug design.
Predicting the shapes that natural proteins will take is one of the preeminent challenges in biology, and modeling even a small protein requires making trillions of calculations. Over the last three years, volunteers around the globe — now numbering about 200,000— have donated their computer down-time to performing those calculations in a distributed network called Rosetta@home. The computing logic behind the network is an algorithm called Rosetta that uses the Monte Carlo technique to find the best “fit” for all of the parts of a given protein.But as the Rosetta volunteers watched their computers blindly trying to work out a solution by methodically testing every possible combination and shape to find the best fit, they began to think that a little human intervention might speed things up. “People were writing in, saying, 'Hey! The computer is doing silly things! It would be great if we could help guide it,'” remembers Baker, who is based at the University of Washington (UW) where he developed the Rosetta algorithm and network.
Baker didn't know how he could make that happen until about 18 months ago, when he went hiking on Mt. Rainier with his neighbor David Salesin, a University of Washington computer scientist who also runs a research laboratory at nearby Adobe Systems. Baker and Salesin began discussing ways to make Rosetta more interactive. With the inherent fun of competition, Salesin thought a multiplayer online game was the way to go. By the time they got back to the car, they had settled on that idea. Salesin provided Baker with the names of three colleagues, led by UW computer scientist Zoran Popovic, who could help Baker create the game.
Over the next few months, doctoral student Seth Cooper and postdoctoral researcher Adrien Treuille, working with Popovic and Baker, created the program, and team tested it in small venues. One match between teams from the University of California and the University of Illinois aroused unexpected fervor and cheering among spectators. “30 or 40 people participated,” says Baker. “The competition was very intense.”
“Foldit” takes players through a series of practice levels designed to teach the basics of protein folding, before turning them loose on real proteins from nature. “Our main goal was to make sure that anyone could do it, even if they didn't know what biochemistry or protein folding was,” says Popovic. At the moment, the game only uses proteins whose three-dimensional structures have been solved by researchers. But, says Popovic, “soon we'll be introducing puzzles for which we don't know the solution.”
Solve Puzzles for Science: Fold It!
HHMI press release: Researchers Launch Online Protein Folding Game...; UW press release: Game's high score could earn the Nobel...
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