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Torax Medical launches study of new LINX Reflux management system

Devices/Technology

Torax Medical Inc., a medical device company focused on the minimally invasive treatment of gastroesophageal reflux disease (GERD) has commenced a pivotal clinical trial of its LINX Reflux Management System.

The trial, which is being conducted at 15 leading academic and private medical centers in the U.S. and Europe, will evaluate the safety and effectiveness of the LINX System in patients suffering from GERD despite medical therapy.

GERD is caused by a defective lower esophageal sphincter, a ring-like muscular valve that surrounds the esophagus. When defective, it allows abnormal reflux of stomach acids and bile into the esophagus. Approximately 19 million adults in the U.S. suffer on a daily basis from the symptoms of GERD. Medical therapy, such as the daily use of proton pump inhibitors (PPIs), may improve heartburn symptoms but it does not address the mechanically defective sphincter, allowing gastric reflux to continue. Chronic gastric reflux may lead to numerous complications including ulcerations and esophageal cancer. The incidence of esophageal cancer is rising at a faster rate than any other cancer in the U.S.

Robert Ganz, M.D. of Minnesota Gastroenterology and a Principal Investigator in the trial shared these comments, “Many people who suffer from GERD do not get complete relief of symptoms with drug therapy. The LINX System is intriguing because it may provide both symptom relief and correction of the physiologic defect.”

The LINX Reflux Management System is intended to restore the normal barrier function in the esophagus for patients who suffer from GERD and is designed to be an outpatient, minimally invasive procedure. The device is implanted laparoscopically, with the patient likely to resume normal activities and diet at discharge. In addition to its therapeutic benefits, Torax Medical anticipates that the LINX System will have the potential to eliminate the burdens associated with lifelong drug therapy and the typical complications associated with conventional surgical repair.

Todd Berg, President and CEO of Torax Medical, considers the LINX System a promising advancement for the treatment of GERD, “We believe the simplest approach to treating GERD is to augment the body’s existing sphincter so that it can function normally. Excellent clinical results were achieved in feasibility trials with the LINX System and we expect these positive clinical outcomes to continue in this Pivotal Trial”.

http://www.toraxmedical.com

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How men and women cope differently with stress traced to genetic differences

Medical Research News

Can people's differing reactions to situations of stress be attributed at least in part to genetic differences and do those differences affect men and women in different ways - with the edge seemingly favoring the women? Research conducted at the Hebrew University of Jerusalem would seem to indicate that the answer to both questions is yes.

Some people appear to be resilient to difficult conditions, whereas others react adversely to such challenges, incurring a range of physical and mental disorders. Much research has shown that the way in which the brain and body adapt to acute and chronic stress are critical for physical and mental health. Further, according to a recent report by the World Health Organization (WHO), stress will be the second leading cause of mortality worldwide over the next 20 years.

It is generally believed that the genetic code plays a prominent role in different responses to stress. It has been estimated that the heredity factor determines by some 62 percent the level of the stress hormone (cortisol) in our bodies. However, only a handful of investigations so far have documented the role of specific genetic variants on shaping the stress response among individuals.

In an effort to reveal a genetic basis for coping with stress, the Hebrew University researchers devised a laboratory-based social stress test. The trials were carried out on students at the Hebrew University Department of Psychology and at the Aaron Beare Research Laboratories at Herzog Hospital by Idan Shalev, a doctoral student of Hebrew University Psychology Prof. Richard Ebstein, and in collaboration with Dr. Marsha Kaitz of the Department of Psychology. The results were published recently online in the journal Psychoneuroendocrinology.

In the test, the researchers examined the salivary cortisol response in 97 university students via the Trier Social Stress Test (TSST) devised at Trier University in Germany. The TSST measures changes in salivary cortisol to assess stress reactivity to challenging social situations.

The students were told that they would play the role of an interviewee for a job and had five minutes to convince the interviewers to hire them. The interview was carried out with a microphone and camera in front of a panel of three straight-faced judges. Additionally, in a second phase of the interview, subjects were tested in a mental arithmetic task in which they were asked to count backwards (out loud) from 1,687 in multiples of 13 as quickly and accurately as possible. If the subject made a mistake he or she was asked to start the series again.

In addition to testing the cortisol level, mouthwash samples were taken and subjects were genotyped for the brain-derived neurotrophic factor (BDNF) gene, which is involved in supporting the growth and differentiation of brain cells. Importantly, animal studies show that BDNF expression is reduced in chronic stress and restored by antidepressant treatment.

The BDNF gene is characterized by a variant that codes for either the valine (Val) or methionine (Met) amino acids. Individuals carry two copies of each gene, with the Val variant being more common. In the study, subjects carrying two copies of the VAL variant (Val/Val), were compared in their cortisol response to those carrying one copy of the Val and one of the Met (Val/Met).

When looking at the responses of the subjects in the stress testing, it was seen that the Val/Met men and women carriers had nearly equal cortisol levels. However, the men with the Val/Val variant had a higher cortisol response (and therefore a higher reaction to social stress) than the men carrying the Val/Met variant. For the women, surprisingly, the opposite was found: the Val/Val women had a lower cortisol response than the Val/Met women. Why the Val/Val variant produces opposite stress reactions (raising it for the males and lowering it for the females) remains an enigma.

Because of the predominance of the Val/Val type for both sexes, the males showed overall greater stress in the testing than the females.

The Hebrew University researchers point out that their investigation shows the importance of genotyping as an aid in helping to resolve paradoxical observations related to stress-related sex differences and also in providing new insight into understanding how depression and other psycho-neurological illnesses may be the result of a combination of stressful life events and genetic factors.

In conclusion, say the researchers, the study specifically indicates that women with the BDNF Val/Met genotype and men with the Val/Val may be particularly vulnerable to social stress mediated by brain stress system activity.

http://www.huji.ac.il/huji/eng/

New methods and tools for the development of embedded systems

Devices/Technology

Together with its European research partners, VTT Technical Research Centre of Finland has developed new methods and tools for the development of embedded systems. The aircraft, car, industrial automation, electronics and telecommunications industries in particular can benefit from methods for the development of even safer systems than before.

The challenge for the future posed by embedded systems is to reduce costs, improve quality and bring new products to market faster than before. A methodology that supports the development of embedded systems was developed in a pan-European research project. The methodology provides a modelling process that supports platform-based development and a modelling language and modelling techniques for the modelling of applications and the platform. In addition, the methodology provides methods and tools for the evaluation of the quality of embedded systems already during the design phase. The study also specified an integrated development environment that provides its users with methods for transforming models from one form into another as one moves from one stage of development to another, as well as with the opportunity of tracing the design results from requirements to implementation or vice versa.

The new methodology, including a set of methods and tools, is suitable for the development of various types of embedded systems. The architectural style created by the researchers ensures broad applicability because the style can be applied in different application fields. Furthermore, the reference architecture template provides a set of pre-defined core services and domain-specific services for the implementation of the execution platform.

"The most significant advantage of the uniform system methodology is the cost savings it enables. The savings are achieved when the results of the expensive development work of platform services can be utilised more than once in different application fields and when flaws and deficiencies can be corrected before the system's actual implementation," says Eila Ovaska, Research Professor at VTT.

The reusable services ensure the same quality level of system development. Quality is an essential aspect of nearly all embedded systems but its importance is emphasised in applications where safety is crucial, such as in aircraft and cars. Quality is also emphasised when the application domain has certain special requirements related to information security, usability or modifiability.

In addition to its use in aircraft, cars and industrial automation, the methodology can also be utilised in distributed embedded systems such as distributed control, measurement and communication systems at home, in office, industry or urban environments.

The research was mostly carried out with funding provided by the EU Seventh Framework Programme. The project was coordinated by the Vienna University of Technology and included the participation of 23 partners from 11 European countries.

http://www.vtt.fi/

Big men more susceptible to atrial fibrillation

Men's Health News

Older men who were big during their 20s face an increased risk of suffering from atrial fibrillation, or abnormal heart rhythm. New research from the Sahlgrenska Academy, University of Gothenburg, Sweden, reveals that height and weight are both factors.

The results are being published in the latest issue of the European Heart Journal.

The study was initiated in 1970. Over 7,000 men living in Gothenburg aged between 45 and 55 were examined and asked questions about their lifestyle. The subjects were asked to state their weight at the age of 20. The research material has now been compared with the National Patient Register.

"Atrial fibrillation proved to be significantly more common both among those men who were big during their youth, as well as among those who gained a considerable amount of weight later on in life," says Annika Rosengren, Professor of Medicine at the Sahlgrenska Academy.

The study reveals that the risk of atrial fibrillation increases linearly with both body size and weight gain. The larger the men were in their 20s and the more weight they gained during their life, the greater the risk.

The fact that the men were big in their youth does not mean that they were obese. Obesity in young men was extremely unusual during the 1930s and 40s, and these big men were quite simply tall and well-built.

"Since both weight and height are increasing among young people, it's quite likely that atrial fibrillation will become more common when today's young men reach their 60s and 70s, particularly if the tendency to put on several kilos later on in life continues," says Annika Rosengren.

http://www.sahlgrenska.gu.se/

Intestinal cancer in spite of screening

Medical Research News

Only every second patient with colorectal carcinoma had taken part in an early detection program within the last ten years.

This is the result, at least for a group of 212 colorectal cancer patients whose screening behavior is examined in the current edition of Deutsches ?zteblatt International (Dtsch Arztebl Int 2009; 106[12]: 195-201) by Konrad Schoppmeyer and his colleagues from Leipzig University Hospital.

The authors have performed a retrospective analysis of the data on screening examinations for the ten years before the diagnosis of colorectal cancer.

In 83% of patients, the colorectal carcinoma was discovered after symptoms had developed. In 17% of patients, the diagnosis was made during screening. In the 10 years before the diagnosis, 51% of the colorectal cancer patients had used screening tests for early recognition. The most frequent of these was the test for fecal occult blood-although this was mostly not in accordance with the guidelines. 25 patients had undergone colonoscopy, 20 of these within the five years before diagnosis.

The most frequent reason that screening tests were not used was that patients were unaware of what was available. Schoppmeyer et al. therefore advocate that doctors should provide their patients with more detailed advice. Moreover, procedures should be in accordance with the guidelines.

Colorectal carcinoma is the second most frequent cause of death from cancer in Germany. The prognosis improves with early detection.

http://www.aerzteblatt.de/

Getting the word out when the need for speed is critical to public health

Healthcare News

When the need for speed is critical, how can a public health department communicate with doctors and hospitals, sending alerts to help prevent or stop a public health crisis? How can thousands of health-care providers be notified about disease outbreaks, illness from food borne contaminants or even a possible pandemic?

Researchers from the Regenstrief Institute, Inc. in collaboration with the Marion County Health Department (Indianapolis, Ind), have developed and tested a technology that allows public health officials to abandon a traditional, inefficient paper approach to alerting the medical community about public health crises in favor of an electronic strategy to seamlessly and instantly push out information critical to patient care.

Regenstrief is demonstrating its pioneering and potentially life saving technology to health care, government, public health, industry and other health information technology leaders at the Healthcare Information and Management Systems Society's (HIMSS) Conference and Exhibition April 4 - 8 in Chicago.

To enable instant delivery of public health alerts to physicians, Regenstrief health-care information technology professionals have created a web application that interfaces with their DOCS4DOCS service, operated by the Indiana Health Information Exchange (IHIE).

DOCS4DOCS is a clinical messaging service that delivers more than one million messages with information, such as laboratory or other test results, critical to patient care to physicians and other care providers each day throughout central Indiana. The public health department will now be able to create a message and securely send that message via DOCS4DOCS to clinicians when and where they are likely to utilize the information to improve patient care.

Like most other public health departments across the nation, the Marion County Health Department has traditionally performed the public health alert function using a variety of methods, including news releases targeted to the public and posting letters to physicians. Postal delivery service can delay notification to primary care physicians by 72 to 96 hours - a critical time in which the opportunity to better serve patients has been lost.

"One of the best ways to stop disease outbreaks is to rapidly identify and treat the cases," said P. Joseph Gibson, MPH, Ph.D., director of epidemiology, Marion County Health Department. "So when a public health department detects an outbreak, it is often important to rapidly notify all the doctors in the area, so they may increase their index of suspicion for the illness, and do more testing and treatment."

"Maintaining accurate contact information for doctors in a city the size of Indianapolis can be challenging. That's where the well-established DOCS4DOCS alert system will be advantageous. DOCS4DOCS maintains the system, so the health department is relieved of the effort of trying to keep their contact information up to date," said Gibson.

Home of the Regenstrief Medical Records System, one of the world's oldest electronic medical records systems, the Regenstrief Institute has been capturing and aggregating health-care data from throughout Central Indiana since 1994. Today metropolitan Indianapolis is the most health-care wired city in the nation.

"Our public health broadcast messaging initiative leverages Regenstrief's core standards-based health information exchange infrastructure in novel ways to improve the health of our community. By building on existing proven technology already used for clinical health care, we minimize development costs and rapidly implement technology that delivers real-world value to public health," said Shaun Grannis, M.D., Regenstrief Institute research scientist and Indiana University School of Medicine assistant professor of family medicine.

Last year Regenstrief investigators received a $10 million, 5-year contract from the Centers for Disease Control and Prevention (CDC) to accelerate the real-time ability of local, state and regional entities to share data and information to enhance rapid response to and management of potentially catastrophic infectious disease outbreaks and other public health emergencies.

"DOCS4DOCS is a robust, efficient communication system that can reach virtually all health-care providers in the Indianapolis metropolitan area. On a daily basis it provides essential information that facilitates and enhances clinical practice, and it also provides a superb platform for public health to send critical information to the medical community. It is a prime example of a bidirectional communication system that other communities should seriously consider for implementation," said Charles Magruder, M.D., M.P.H., senior advisor, Health Information Exchange Activities, National Center for Public Health Informatics at the CDC.

After further evaluation, Regenstrief plans to offer the new technology to other public health departments.

http://www.iupui.edu