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The Scottish Intercollegiate Guidelines Network (SIGN) have issued new guidelines for the treatment of stroke, giving clopidogrel (Plavix®) a Grade A recommendation as a monotherapy alternative to the combination of aspirin and dipyridamole in the secondary prevention of vascular events.(1)

New data has been published demonstrating the efficacy of clopidogrel in this indication since the previous guidelines were produced, such as... PRoFESS*, the largest ever trial of its kind in stroke. With the publication of these guidelines, Scotland has again shown itself to be leading the way in terms of using the most recent clinical data to inform the guidance issued for its clinicians.

Under the previous SIGN guidelines, aspirin and dipyridamole was the recommended 1st-line treatment for the secondary prevention of stroke, with clopidogrel only mentioned as a good practice point.(2) The new guidelines recommend that clopidogrel is considered as an alternative to the combination of aspirin and dipyridamole after someone has had a, ischaemic stroke, for the secondary prevention of vascular events. Both treatment options have Grade A status in recognition of the body of clinical evidence supporting their use in this indication.

Chest, Heart & Stroke Scotland Chief Executive David Clark said, "We very much welcome the new guidelines, but we must make sure that the resources are made available to provide these treatments, and that the guidelines are put into practice so that all potential Scottish stroke patients benefit. We also need to improve awareness about the signs and symptoms of a stroke and to drive home the message that stroke is a medical emergency - we are already working with the NHS through our FAST campaign to achieve this."

Stroke is the 3rd largest cause of death and the largest cause of severe disability in Scotland, as it is UK-wide.(3,4) There are an estimated 100,000 stroke survivors currently living in Scotland.(4)

The National Institute for Health and Clinical Excellence (NICE) published their most recent clinical guidelines on stroke in July 2008 (prior to the publication of the PRoFESS data in August) and are currently revising their Technology Appraisal on clopidogrel and dipyridamole for use in vascular disease (expected in 2010).(5)

Clopidogrel has been prescribed for over 10 years in a broad range of atherothrombotic patients, amongst whom it has been shown to provide early and long-term protection against future vascular events. Clopidogrel has a well-known safety and efficacy profile.(6-10)

Notes:

*PRoFESS: Prevention Regimen For Effectively avoiding Second Strokes11

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

Plavix® (clopidogrel) is manufactured by sanofi-aventis and Bristol-Myers Squibb.

References:

1 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke or TIA: assessment, investigation, immediate management and secondary prevention (SIGN 108) (2008)

2 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke: Rehabilitation, Prevention and Management of Complications, and Discharge Planning (SIGN 64) (2002)

3 Department of Health website, http://www.dh.gov.uk/en/healthcare/nationalserviceframeworks/stroke/index.htm (last accessed December 11th 2008)

4 The Stroke Association, http://www.stroke.org.uk/in_your_area/scotland/index.html (last accessed 12th December 2008)

5 National Institute for Health and Clinical Excellence (NICE), Clopidogrel and dipyridamole for the prevention of artherosclerotic events (Technology Appraisal 90). (May 2005)

6 CAPRIE Steering Committee. A randomised, blinded trial of Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE). Lancet 1996; 348: 1329-1339.

7 The Clopidogrel in Unstable angina to prevent Recurrent Events trial investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. NEJM 2001; 345: 494-502.

8 COMMIT (Clopidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005; 366: 1607-1621.

9 Sabatine MS et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. NEJM 2005; 352: 1179-1189.

10 Yusuf S et al. Early and late effects of clopidogrel in patients with acute coronary syndromes. Circulation 2003; 107: 966-972.

11 PRoFESS Study Group. Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke. NEJM 2008; 359 1-14

Sources:
Caroline Almeida
Bristol-Myers Squibb

Jeannine Nolan
sanofi-aventis

Abbott (NYSE: ABT) announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries. Patients who received Abbott's bioabsorbable drug eluting coronary stent and... were followed out to two years experienced no stent thrombosis out to two years and no new major adverse cardiac events (MACE) between six months and two years. These results confirmed earlier positive one-year clinical results with Abbott's bioabsorbable drug eluting stent. The results were presented today at the Cardiovascular Research Foundation's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

"Now you see it, now you don't -- for the first time, we have data in patients showing that Abbott's bioabsorbable drug eluting stent does its job treating diseased coronary arteries and that it is absorbed by two years," said John Ormiston, M.D., principal investigator in the ABSORB trial and medical director at Mercy Angiography in Auckland, New Zealand. "Clinical safety and effectiveness were sustained at two years, and the previously stented portion of arteries demonstrated the ability to expand and contract in a manner similar to a vessel that has never been stented. These are very exciting results that represent a potential major breakthrough in the future treatment of patients with coronary artery disease."

Trends were observed in data from tests of artery movement and function, demonstrating a potential restoration of unstented artery movement to coronary blood vessels after the stent was absorbed -- something that is not possible with permanent metal-based stent implants.

Abbott also will present groundbreaking intravascular ultrasound (IVUS) and optical computed tomography (OCT) imaging data on its bioabsorbable drug eluting coronary stent platform this week at TCT in the "Best of Coronary Interventions Abstracts" session at 9:20 a.m. Eastern time on Wednesday, Oct. 15, 2008. IVUS data will reveal a decrease in plaque area in treated arteries corresponding to a similar increase in blood flow area between six months and two years: 12.7 percent decrease in plaque area (p=<0.001, n=17); 10.8 percent increase in luminal area (p=0.03, n=17). OCT imaging data will show absorption of the stent into artery walls and that the blood vessel lining of arteries treated with Abbott's bioabsorbable stent looks more uniform after two years than it did immediately post-treatment.

"The imaging technology data from the ABSORB trial indicate that Abbott's bioabsorbable stent has the potential to restore vascular integrity and endothelial function to treated vessels after two years," said Professor Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB trial. "With these ABSORB data, we have come full circle in interventional time, linking the past, when balloon angioplasty was used without stents, to the future, when disappearing stents may become the new standard of care for patients with coronary artery disease."

Abbott is the only company with long-term clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent out to two years. Abbott's bioabsorbable everolimus eluting coronary stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, Abbott's bioabsorbable stent is designed to restore blood flow by propping a clogged vessel open, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.

"The early success of our bioabsorbable stent marks the dawn of the beginning of a new era in the history of interventional medical device treatment," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Today's data show that bioabsorbable stents have become more than just a wish for patients -- they are now on their way to becoming a clinical reality."

Abbott will begin enrolling the next cohort of 80 patients into its international ABSORB clinical trial in the first half of 2009.

ABSORB Clinical Trial Results

Two-year data from the first 30 patients enrolled in the ABSORB clinical trial demonstrated a low (3.6 percent, n=28) MACE rate, which was consistent with results at one year (3.4 percent, n=29) and before six-months (3.3 percent, n=30). One patient had a minor heart attack due to lack of blood supply at six-months, another was electively lost to follow up at one year, and one patient died from a non-cardiac cause at two years. A zero percent stent thrombosis rate persisted for all patients across all time points in the ABSORB trial. Potential restoration of unstented artery movement to coronary blood vessels after the bioabsorbable stent was absorbed was revealed at two years with the drugs acetylcholine and nitroglycerin used in nine patients, showing vasodilation in the previously stented area, and methergine used in seven patients, showing vasoconstriction in the previously stented area.

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 110 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. Key endpoints of the study include assessments of safety -- MACE (defined as any event that resulted in re-treatment of the treated artery, heart attack or cardiac death) and stent thrombosis (blood clot formation) rates -- at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

For images of Abbott's bioabsorbable stent and other information, please visit the company's online TCT newsroom at http://www.abbottvascular.com/presskit.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.

Abbott

Antiplatelet medicine, AGGRASTAT® (tirofiban HCL), a glycoprotein IIb/IIIa inhibitor, has been shown to significantly lower the incidence of heart attack after elective coronary angioplasty, in patients with coronary artery disease who have shown poor response to standard oral antiplatelet agents such as... aspirin and clopidogrel.1 These results were announced at the Annual European Society of Cardiology Congress in Munich, Germany.

"These findings are significant in that we demonstrate a proof of concept for a new treatment strategy in a patient segment whose needs have so far remained unaddressed - managing for the increased risk of thrombotic events due to non-responsiveness of patients to standard oral antiplatelets such as aspirin or clopidogrel," said Dr Marco Valgimigli, Chair of Cardiology, University of Ferrara, Italy and principal investigator of the 3T/2R Study (Tailoring Treatment with Tirofiban in patients showing Resistance to aspirin and/or Resistance to clopidogrel).

Inhibition of platelet aggregation following an intake of aspirin or clopidogrel varies greatly among patients, and previous studies have shown that poor response to oral antiplatelet agents increases the risk of thrombotic events, especially after coronary angioplasty.1 It was previously unknown if this reflected suboptimal platelet inhibition per se which might benefit from alternative or more potent antiplatelet agents.

Enrolled in the study were 263 patients who were poor responders to aspirin and/or clopidogrel, based upon a point-of-care assay, who underwent elective coronary angioplasty at ten European sites for stable or low-risk unstable coronary artery disease. Patients were randomly assigned in a double blind manner to receive either AGGRASTAT® or placebo on top of standard aspirin and clopidogrel therapy.1 The primary end point was the occurrence of periprocedural myocardial infarction, as defined by an increase in Troponin I or T within 48 hours, and was observed in 20.4 percent of patients treated with AGGRASTAT®, compared to 35.1 percent of patient treated with placebo.1 This resulted in a significant reduction of major adverse cardiovascular events within 30 days in the AGGRASTAT® group compared to the placebo group (21.2 percent versus 36.6 percent, respectively; p=0.0065).1 The incidence of bleeding was low and did not differ between the two groups.1

"Current treatment strategies for patients with coronary artery disease ignore the individual response to antiplatelet agents, and likewise fail to identify therapeutic targets for platelet reactivity necessary to intensify treatment," said Dr Paul Gurbel, Director of Cardiovascular Research, Centre for Thrombosis Research, Sinai Hospital, Baltimore, USA. "These findings illustrate the efficacy and safety of AGGRASTAT® in treating poor responders to aspirin or clopidogrel, as compared to standard care. This study shows that by assessing response to standard antiplatelet agents by a point-of-care assay, intensity of treatment can be modulated accordingly."

Dr Gurbel further commented, "These data are in accordance with our earlier results from the CLEAR PLATELETS studies that have demonstrated the strong association between high periprocedural platelet reactivity and the risk of in-hospital myocardial infarction in patients undergoing elective stenting. The use of glycoprotein IIb/IIIa inhibitors, in patients identified as poor responders to oral antiplatelet agents by objective measurements of platelet function, makes perfect sense and deserves greater attention in future studies."

"These data findings are extremely encouraging for this patient population and we believe it reinforces the potential benefits of high-dose bolus AGGRASTAT®," said John Vavricka, President and Chief Executive Officer of Iroko Pharmaceuticals. "Iroko is committed to furthering clinical research in this area, and exploring AGGRASTAT®'s potential for patients who do not respond to oral anti-platelet therapy."

In January of 2008, Iroko Pharmaceuticals acquired all non-US commercial rights to AGGRASTAT® from Merck & Co., Inc. The 3T/2R study was initiated and conducted by the University of Ferrara, Italy with an unrestricted grant from Merck & Co., Inc. and Iroko.

About AGGRASTAT®

AGGRASTAT®, a glycoprotein IIb/IIIa inhibitor, is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes. Patients most likely to benefit from AGGRASTAT® treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA.

In most patients, AGGRASTAT® should be administered intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min. For complete information, please refer to the product's prescribing information. AGGRASTAT® is intended for use with acetylsalicylic acid and unfractionated heparin.

AGGRASTAT® (tirofiban hydrochloride) is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT®; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; or history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. AGGRASTAT® should be used with caution in patients with platelet count <150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic hemodialysis patients. Because AGGRASTAT® inhibits platelet aggregation; caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.

The following additional adverse reactions have been reported in post- marketing experience: bleeding, intracranial bleeding, retroperitoneal bleeding, hemopericardium, and pulmonary (alveolar) hemorrhage. Fatal bleedings have been reported; body as a whole: acute and/or severe decreases in platelet counts which may be associated with chills, low grade fever, or bleeding complications; hypersensitivity; rash and/or hives.

Please refer to the specific Prescribing Information for your country for complete warnings and precautions.

About Iroko

Iroko is a pharmaceutical company focused on acquiring, developing, and maximizing the potential of currently marketed pharmaceutical products on a worldwide basis. Iroko applies concentrated selling and marketing efforts and product life cycle management strategies focused on developing new and relevant formulations and indications that benefit patient health. For more information, visit http://www.iroko.com.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. http://www.merck.com

References

1 Valgimigli M, Campo Gianluca, de Cesare N, Meliga E et al. A double-blind randomised multicentre trial of tailored infusion of tirofiban in poor aspirin and/or clopidogrel responders undergoing elective percutaneous coronary intervention. Presented at ESC, 2 September 2008

Merck & Co., Inc

Four studies published in a leading journal this week suggest that metabolic disorders such as obesity and diabetes may share risk factors that affect the development of Alzheimer's disease, other forms of dementia and cognitive decline.

The studies are published in the March issue of Archives of Neurology, a JAMA/Archives journal and find that:...

1. The more components of metabolic syndrome a woman has, the more likely she is to develop cognitive impairment
Dr Kristine Yaffe of the University of California, San Francisco, and the San Francisco Veterans' Affairs Medical Center, and colleagues recruited nearly 5,000 women of average age 66 with no cognitive impairment and followed them for four years. Of the 10 per cent who had metabolic syndrome, 7 per cent developed cognitive impairment compared with 4 per cent who did not have metabolic syndrome. The risk of developing cognitive impairment went up for each additional metabolic syndrome component present. (Click here for more info).

2. A man who is obese in old age is more likely to have worse cognitive function
Dr Alka M Kanaya of the University of California-San Francisco, and colleagues studied over 3,000 elderly people enrolled in the Health ABC Study. They assessed their overall body fat (adiposity) from their their body mass index, waist size, saggital diameter (from highest point of abdomen to the back), total fat, subcutaneous fat (under the skin) and visceral fat (between internal organs). Men with higher levels of body fat performed worse in cognitive function tests taken at the beginning of the study and after three, five and eight years. But no such link was found in the women.(Click here for more info).

3. Being obese in middle age, or underweight in old age puts a person at greater risk of dementia
Dr Annette L Fitzpatrick of the University of Washington, Seattle, and colleagues followed 2,700 adults of average age 75 without dementia who reported their weight in midlife (age 50) and had their height and weight measured in late life (age 65 and over). The average follow up was 5.4 years. They found that those people who were obese in midlife (body mass index, BMI, over 30) were more likely to develop dementia than those of normal weight. However, in late life the picture was quite different. Being obese in late life appeared to protect against dementia, while being underweight (BMI under 20) put a person at increased risk, and being overweight had no effect. (Click here for more info).

4. A person with Alzheimer's disease who has a history of diabetes and higher levels of total and "bad" (LDL) cholesterol is more likely to have a faster rate of cognitive decline
Dr Elizabeth P Helzner and colleagues at the Columbia University Medical Center, New York, studied 156 patients who were diagnosed with Alzheimer's at average age 83 and followed them for an average of 3.5 years. Over this time, those with higher LDL ("bad" cholesterol) and total cholesterol before diagnosis showed a faster decline on tests of cognitive function compared to those whose cholesterol was normal. This was the same for those who had a history of diabetes compared to those who did not. (Click here for more info).

Metabolic syndrome is a group of risk factors that predisposes a person to heart disease, diabetes, and other conditions. The risk factors include: obesity, mild glucose abnormalities, high blood pressure, and adverse changes in blood fats.

Metabolic syndrome affects about one in five people and older people more. Some studies suggest 1 in 4 people in the US have the condition.

In an accompanying review titled " Insulin Resistance May Links Metabolic and Cognitive Disorders", Dr Suzanne Craft of Veterans Administration Puget Sound Health Care System and University of Washington School of Medicine in Seattle, suggested that insulin resistance, which is when the tissues in the body stop being sensitive to the hormone that controls glucose levels, may be behind dementia and metabolic disorders like diabetes and obesity.

Craft wrote:

"Considerable progress has been made in establishing relationships among metabolic disorders and late-life dementing illnesses."

"A number of challenges must be addressed as we move forward to determine the key mechanisms underlying these associations," she concluded, while emphasizing the need to have clear definitions of both metabolic and neurological conditions.

"Future research aimed at identifying mechanisms that underlie comorbid associations will not only provide important insights into the causes and interdependencies of late-life dementias, but will also inspire novel strategies for treating and preventing these disorders," wrote Craft.

Sources: JAMA/Archives.

WHAT:

Women with suspected coronary artery disease who suffer from depression have significantly higher health care costs than those who are not depressed, according to findings from the Women's Ischemia Syndrome Evaluation (WISE), an ongoing, multicenter study funded by the National Institutes of Health.

Previous studies have shown that patients suffering from certain medical conditions and depression have greater health expenses than... those without depression. Because women are diagnosed with depression at twice the rate of men, the study of costs related to depression and women's health issues is particularly important.

WHO:

C. Noel Bairey Merz, M.D., is available to provide additional details. She is one of the journal article authors and chair of the multicenter WISE initiative, which is investigating potential methods for more effective diagnosis and evaluation of coronary artery disease in women. Bairey-Merz serves as director of the Women's Heart Center at the Cedars-Sinai Heart Institute, where she also directs the Preventive and Rehabilitative Cardiac Center at the Cedars-Sinai Heart Institute. A professor of medicine at Cedars-Sinai Medical Center, she holds the Women's Guild Endowed Chair in Women's Health.

DETAILS:

This study, conducted among 868 women undergoing evaluations for possible coronary artery disease, used three different approaches to measure depression (history of treatment for depression, use of antidepressant medications, and a standard, widely accepted questionnaire). Seventeen percent to 45 percent of the women in the study met depression criteria.

Depression was associated with 15 percent to 53 percent increases in cardiovascular costs over five years. Translated into dollar figures, annual cardiovascular costs were $1,550 to $3,300 higher for depressed women than for those who were not depressed (depending on the depression criteria used).

Several factors appear to be responsible for these increased costs, but one clear association is the fact that the depressed women experienced more cardiovascular disease events. Interestingly, relationships between depression and costs were particularly strong among women who did not have evidence of significant coronary artery disease, suggesting that depression may play a larger cost role in women who do not have traditional markers of heart disease. These results combined with prior work suggest that women with symptoms of heart disease without obstructive CAD are more prone to depression possibly secondary to misdiagnosis and misunderstanding. More research is needed," said Bairey Merz.

RAMIFICATIONS:

The findings suggest that depression is an important factor in understanding overall and cardiovascular-related costs in women who have symptoms of heart disease. Although it is not currently known whether treatment for depression can lower costs in cardiac populations, the results support future research in this area.

FUNDING:

The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health, the National Center for Research Resources, the Gustavus and Louis Pfeiffer Research Foundation, The Women's Guild of Cedars-Sinai Medical Center, The Ladies Hospital Aid Society of Western Pennsylvania, and the Edythe Broad Endowment for Women's Heart Research.

Notes:

The study abstract can be accessed

Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced that the first series of patients have been successfully treated with the MitraClip(R) system at the Cardiocentro Ticino in Lugano, Switzerland. The MitraClip(R) system is the only medical device commercially available in the European Union which provides a non-surgical mitral valve repair option for... patients suffering from the effects of functional and degenerative mitral regurgitation (MR).

Mitral regurgitation is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. In the vast majority of patients, the MR is untreated, requiring the heart to work harder and ultimately leading to heart failure.

The first patients in Switzerland were treated by the team led by Prof. T. Moccetti, M.D., assisted by G.B. Pedrazzini, M.D.; E. Pasotti, M.D.; F.F. Faletra, M.D.; and A. Auricchio, M.D., Ph.D.

"Until now, many heart failure patients with associated functional MR had no therapeutic options except medical management when surgery was not possible either because they have already had heart surgery, or presented with important renal insufficiency or lung disease, all of which significantly increase the risk of a second or a third operation," said Prof. Moccetti, Head of Cardiology Division and Medical Director of Cardiocentro Ticino. He added "The MitraClip(R) therapy provides a valuable alternative for these patients."

Professor Auricchio, Director of the Heart Failure Clinic commented: "Heart failure is a devastating disease, significantly more common than cancer and has the same poor life-expectancy. Implantable devices such as cardiac resynchronization therapy have improved the quality of life of these patients. Now with percutaneous mitral valve repair, I am confident we can expand our treatment possibilities to many of our Swiss heart failure patients."

Evalve initiated commercial sales of the MitraClip(R) system in Europe under the CE Mark in September 2008. The company is employing a direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. The company has worked closely with hospitals to deliver high quality training programs in preparation for the first series of implants. The MitraClip(R) device is now currently being implanted in five countries, including Germany, Italy, the United Kingdom, the Netherlands and now Switzerland.

"We are very pleased to see the successful initial use of the MitraClip device in Switzerland at this important cardiac center," said Ferolyn Powell, president and chief executive officer of Evalve. "The functional MR heart failure patient continues to be the fastest growing segment of the population undergoing treatment with the MitraClip(R) system and the initial commercial results in this population are very encouraging."

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve's MitraClip(R) device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip(R) device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc., headquartered in Menlo Park, Calif., has developed a proprietary system which enables percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., and for an animated explanation of the procedure using the MitraClip(R) device, visit http://www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (http://www.thefoundry.com).

The MitraClip(R) system is currently undergoing clinical evaluation in the United States and Canada.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.

Evalve, Inc.

A heart surgeon and a cardiologist specializing in electrophysiology have collaborated to perform the nation's first-ever Convergent Ex-Maze procedure to correct atrial fibrillation at FirstHealth Moore Regional Hospital. Atrial fibrillation, or afib, is an often debilitating heart disorder that... affects an estimated five million Americans.

Cardiothoracic surgeon Andy C. Kiser, M.D., who led the development of the Ex-Maze procedure for atrial fibrillation, and electrophysiologist Mark Landers, M.D., combined their expertise to perform the groundbreaking Convergent Ex-Maze on Jan. 23, 2009. Each physician had performed his specialty (the Ex-Maze by Dr. Kiser and the percutaneous endocardial catheter ablation by Dr. Landers) separately numerous times before, but never together until the January collaboration.

"This case is significant because we can now treat atrial fibrillation without chest incisions and because by working with the electrophysiologist during the procedure, we can do a complete atrial fibrillation treatment," Dr. Kiser says.

"The power of this new procedure is that we have heart surgeons and cardiologists taking tried-and-true technologies and working together to provide the best option for the treatment of atrial fibrillation," says Dr. Landers.

Atrial fibrillation (afib), which affects an estimated five million people, is the most common type of heart rhythm disturbance. It is the rapid, uncoordinated beating of the atria in the two upper chambers of the heart. With afib, the atria quiver instead of beating in rhythm when the electrical impulses that cause them to contract travel through the heart in chaotic fashion.

There are three types of atrial fibrillation: paroxysmal, persistent and long-standing persistent. Paroxysmal afib occurs when the abnormal electrical signals and rapid heart rate begin suddenly and then stop on their own. Symptoms can be mild or severe and last for seconds, minutes, hours or days. With persistent afib, the abnormal heart rhythm continues until it is stopped with treatment. Long-standing persistent afib lasts for more than one year. Both paroxysmal and persistent atrial fibrillation may become more frequent and eventually result in a long-standing or permanent afib.

Some people with afib are severely debilitated by weakness, shortness of breath or pain while others have no symptoms at all.

The union of the Ex-Maze procedure and catheter ablation provides many benefits to the patient including:

Elimination of chest incisions
Quicker recovery time
Shorter hospital stay
Minimal scarring
Ablation testing at the time of the Ex-Maze to confirm appropriate treatment endpoints

During the Convergent Ex-Maze procedure, the Ex-Maze portion is performed through a small incision in the abdomen while a small catheter is inserted in the large vein in the groin for the catheter ablation.

"This eliminates the need for sometimes painful incisions in the chest and allows instantaneous confirmation of the success of the procedure," says Dr. Kiser. "This approach allows the patient to have a quicker recovery and also allows us to add new lesions to parts of the heart that we couldn't reach before. In addition, it allows patients who travel from great distances for the treatment to be able to fly to the area instead of having to drive."

Dr. Kiser recently traveled to the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas, to observe Rodney Horton, M.D., an electrophysiologist, and Andrew Hume, M.D., a cardiac surgeon, perform the second procedure in the United States. Andrea Natale, M.D., medical director of the heart arrhythmia program at St. David's and an internationally known heart arrhythmia specialist, was also on hand for the procedure.

Various improvements to the traditional open-heart surgery technique have been developed to block the stray electrical impulses of atrial fibrillation and guide electricity onto the correct pathways through the heart. Other traditional treatments include medication, pacemaker implantation and electrical shock, all of which are offered at Moore Regional Hospital.

For many years, the "gold standard" for afib treatment has been a surgical procedure called the Cox Maze, which requires opening the chest, stopping the heart and cutting it into sections before it is sewn back together. Dr. Kiser's Ex-Maze procedure, a novel improvement to the Cox Maze that he developed in collaboration with other surgeons, creates an extensive pattern of scar tissue on the heart's surface and controls the heart's abnormal electrical impulses without the complexity of similar procedures.

"A major advantage of the Ex-Maze is that the procedure is done while the heart is beating, so the patient doesn't have to be on a heart-lung machine," Dr. Kiser says.

Initially, Dr. Kiser performed the Ex-Maze only on patients who were having some other type of open-chest procedure, such as a coronary artery bypass. In 2007, he was invited to Krakow, Poland, where he performed the world's first minimally invasive Ex-Maze procedure using Paracardioscopy, which allows surgeons to look at and operate on the heart by using ports and small cameras. He began offering the Paracardioscopic Ex-Maze as a treatment option at Moore Regional in January 2008.

Catheter ablation, a common medical procedure to treat atrial fibrillation, uses a long, thin, flexible tube (called an ablation catheter) that is typically put into a blood vessel in the arm, groin (upper thigh) or neck. The tube is guided to the heart through the blood vessel, and a special machine sends energy through the catheter to the heart. This energy finds and destroys small areas of heart tissue where abnormal heartbeats may cause an arrhythmia to start. During the Convergent Ex-Maze procedure, the ablation catheter is inserted into the heart through the groin.

The Convergent Ex-Maze can be used to treat all three types of atrial fibrillation, but focuses on those patients who have been difficult to treat with traditional methods.

"Those difficult-to-treat patients, who have had atrial fibrillation for a long time, are the patients we are now treating with this procedure," says Dr. Kiser.

Dr. Kiser is a member of the Cardiovascular and Thoracic Center and chief of Thoracic Surgery at Moore Regional Hospital. Also, the medical director of FirstHealth's Chest Center of the Carolinas and Arrhythmia Center, he has been performing heart and lung surgeries at Moore Regional since 2000 and has performed more than 150 minimally invasive Ex-Maze procedures.

Dr. Landers is affiliated with Pinehurst Cardiology Consultants, a comprehensive cardiology practice in Pinehurst.

For more information on the Convergent Ex-Maze atrial fibrillation procedure developed by Dr. Andy Kiser and Dr. Mark Landers, please contact FirstHealth Moore Regional Hospital at (800) 213-3284 or visit http://www.firsthealth.org/afib. Additional information is also available on the Ex-Maze Web site at http://www.exmaze.com.

CUTLINE

A team of American and Polish physicians performed the world's first Convergent Ex-Maze procedure in Krakow, Poland, in January 2009. Members of that team are (front from left) Rodney Horton, M.D., an electrophysiologist with St. David's Medical Center in Austin, Texas; Andy Kiser, M.D., the Moore Regional Hospital cardiac surgeon who developed the groundbreaking procedure; and Andrew Hume, M.D., a cardiac surgeon with St. David's Medical Center in Austin, Texas; and (back from left) David Haines, M.D., a cardiologist with William Beaumont Hospital in Michigan; and cardiac surgeon Krzysztof Bartus, M.D., of Poland. Source medical update

K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, announced the introduction of an all-inclusive solution for rigid posterior fixation of the cervico-thoracic regions of the spine. The CASPIAN™ Spinal System has received FDA 510(k) and CE Mark clearance for... domestic and international distribution, expanding the global presence of K2M technologies.

This comprehensive system provides two different polyaxial screw options, Mini MESA™ and Mini DENALI™, as well as Mini Hooks and 3.5 mm Rods. The Mini MESA screws feature K2M's flagship Zero-Torque Technology™ which applies zero torsional loads, or twisting forces, to the spine when locking the system. The Mini DENALI screws feature off-axis screw height adjustment, whereby the screwdriver does not need to be co-linear with the screw shaft to adjust the screw during surgery.

According to Dr. Pierce Nunley, Director of the Spine Institute of Louisiana, "The Zero-Torque locking mechanism and ability to do complex manipulations easily on individual screws across multi-level constructs is superior to any other posterior cervico-thoracic reconstruction system on the market."

"The CASPIAN Spinal System is an important introduction for K2M, because it addresses the increasing demand from the surgeon community to offer our innovative MESA Zero-Torque Technology for the upper regions of the spine," stated Eric Major, K2M's President and CEO. "The CASPIAN clearance moves us one step closer to our goal of providing a complete product portfolio of best-in-class systems for treating all types of complex spine pathologies."

About K2M

K2M, Inc. is an innovative spinal device company that develops simplified solutions for the treatment of complex spinal pathologies and procedures. Chief Medical Officer, Chairman and co-founder, Dr. John Kostuik, former Chief of Spine Surgery at The Johns Hopkins University School of Medicine, drives K2M's commitment to redefining the market. K2M's comprehensive line of products include: spinal stabilization systems, minimally invasive systems, and other advancements in spine solutions for Degenerative Disc Disease (DDD), as well as deformity, trauma, and tumor.

K2M, Inc

Researchers at Washington University School of Medicine in St. Louis have linked a potential indicator of Alzheimer's disease to brain damage in humans with no signs of mental impairment.

Although their cognitive and neurological assessments were normal, study participants with lower levels of... a substance known as amyloid beta 42 (A-beta 42) in their cerebrospinal fluid (CSF) had reduced whole brain volumes, suggesting that Alzheimer's changes might already be damaging their brains. Scientists previously showed that low CSF levels of A-beta 42 mark the presence of amyloid deposition in the brain, a key diagnostic marker of the amyloid plaques that characterize Alzheimer's disease.

Evidence is mounting that Alzheimer's harms the brain for many years before physicians and family members can detect symptoms, and this has led many to conclude that successful Alzheimer's treatments may only be possible if scientists find ways to identify pre-symptomatic sufferers.

The results are an encouraging sign that this search for new indicators, known as antecedent biomarkers, may be succeeding, according to senior author David M. Holtzman, M.D., the Andrew and Gretchen Jones Professor and chair of the Department of Neurology at the School of Medicine and neurologist-in-chief at Barnes-Jewish Hospital.

"We still need to confirm with long-term follow-up studies that subjects with this biomarker and brain damage go on to develop the cognitive changes characteristic of Alzheimer's," says Holtzman. "For now, the evidence we've uncovered further proves that identification and treatment prior to the start of the symptoms of Alzheimer's disease are likely going to be essential to preventing irreversible brain injury."

The results were published in the February issue of Annals of Neurology.

A-beta 42 is a protein fragment that clumps together in the brain to form the plaques that have long been the diagnostic hallmark of the disease. In an earlier study, the same Washington University researchers showed that when A-beta 42 decreases in CSF, it begins to build up in the brain.

"The new results show that something associated with amyloid deposition in the brain - either the amyloid itself or some toxic product of it - is causing brain damage in people who are still cognitively normal," says Holtzman.

For the study, led by Anne Fagan, Ph.D., research associate professor of neurology, scientists analyzed CSF samples and brain scans of two groups of subjects at the university's Alzheimer's Disease Research Center. The first group of 29 volunteers had very mild cognitive impairment; the remaining 69 volunteers were cognitively normal. Their ages ranged from 60 to 91.

Researchers analyzed CSF samples and took magnetic resonance imaging (MRI) scans of subjects' brains. They used a computer program to analyze the MRI scans and determine whole brain volume, a measurement of the amount of space taken up by a patient's gray and white matter minus the CSF fluid circulating in the skull.

Participants with normal levels of A-beta 42 in their CSF had whole brain volumes within expected ranges. But in both the cognitively impaired subjects and in cognitively normal volunteers with decreased CSF A-beta 42, the size of the brain was smaller.

In addition to A-beta 42, researchers analyzed CSF levels of a family of proteins called tau proteins. These proteins are a component of structures called neurofibrillary tangles that increase as Alzheimer's disease progresses. Scientists believe increased levels of tangles in the brain lead to increased CSF tau levels.

Researchers found CSF tau levels did not increase until subjects became mentally impaired.

"We've thought for some time that in Alzheimer's disease, amyloid builds up first followed by an increase in tangle accumulation," Holtzman says. "This is some of the first evidence in living people that this idea may be right: large scale changes in amyloid seem to precede large scale changes in tau, which are then linked to the onset of clinical dementia symptoms."

Researchers will follow cognitively normal subjects with reduced CSF amyloid levels and brain volumes to see if they eventually become demented, potentially confirming A-beta 42 as an antecedent biomarker for Alzheimer's disease. They continue to look for additional Alzheimer's biomarkers in CSF samples and brain scans.

Notes:

Fagan AM, Head D, Shah AR, Marcus D, Mintun M, Morris JC, Holtzman DM. Decreased cerebrospinal fluid amyloid beta 42 correlates with brain atrophy in cognitively normal elderly. Annals of Neurology, online publication.

Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.

Source: Michael C. Purdy

The premise of brain training is simple: participants must complete a series of daily exercises such as mental calculation, memorization and enigmas to help increase cognitive ability and avoid certain neurodegenerative diseases. Some companies like Brain Center International, which produces NeuroActive, promise regular users they'll shave 10 years of brain aging after eight weeks of use. Is it surprising some 10,000 copies of... the product were sold in Quebec in the last six months?

"To my knowledge, there is no scientific research demonstrating results from such recreational programs," says Sylvie Belleville, a professor at the Université de Montréal' Department of Psychology and associate research director of the Institut universitaire de gériatrie de Montréal.

According to Belleville, the principles of intellectual stimulation aren't false, but their efficiency haven't been scientifically proven. She argues that Sudoku and crosswords could work just as well.

Yet there are programs that exist that have been proven to benefit seniors and Alzheimer's victims, according to Belleville: "These programs are based on memory strategies. They have nothing to do with the repetitive exercises offered by NeuroActive and others," she says.

While memory products can be helpful, Belleville warns against the unrealistic expectations some may provide. The advertising of these products, she stresses, "Could give false hopes. If someone doesn't see a change they could quit and it could eventually lead to depression."

In her opinion, the best way to keep one's cerebral functions is to do intellectual activities, eat well, control vascular factors, particularly in the case of diabetes and hypertension, and remain physically active.

Notes:

This release is available in French.

On the Web:

About the Université de Montréal: http://www.umontreal.ca/english/index.htm

English adaptation by Marc Tulin; original French story by Dominique Nancy can be consulted here.

Source: Sylvain-Jacques Desjardins

A simple balance test may predict cognitive decline in Alzheimer's Disease, according to a study published in the March 2009 issue of the Journal of Alzheimer's Disease.

This study was carried out in 16 university hospital departments of neurology, geriatrics or psychiatry in ten cities with 686 outpatients suffering from AD. This population is... representative of the AD population seen by clinicians in daily practice. Patients were evaluated by a geriatrician every six months for up to two years, and their degree of cognitive impairment was measured using the Mini Mental State Examination (MMSE). At the same time, a "one-leg balance" (OLB) test was given, where a participant was asked to stand on one leg for as long as possible. The OLB test was reported as abnormal when the participant was unable to stand on one leg for 5 seconds or more.

Participants with an abnormal OLB at baseline or/and during the follow-up showed significantly more cognitive decline at 12, 18 and 24 months than the participants with a OLB test normal at baseline and normal during the follow-up. The worst condition (having an abnormal OLB at baseline and during the follow-up= no improvement) was associated with a mean adjusted cognitive decline of 9.2 points. The best condition (having a normal OLB at baseline and during the follow-up = no worsening) was associated with a mean adjusted cognitive decline of 3.8 points.

Senior Investigator Yves Rolland, Inserm and the University of Toulouse, France, states, "Our results suggested that an abnormal OLB is a marker of more advanced dementia (worst baseline characteristic) and an independent predictor of cognitive decline in AD. Our results reinforce in an AD population, the growing evidence suggesting a link between physical performances and cognitive decline. If these results are confirmed by other data, the OLB test could be adopted in clinical practice to identify AD patients at high risk of rapid cognitive decline."

Notes:

The article is "An Abnormal 'One-leg Balance' Test Predicts Cognitive Decline During Alzheimer's Disease" by Yves Rolland, Gabor Abellan van Kan, Fati Nourhashemi, Sandrine Andrieu, Christelle Cantet, Sophie Guyonnet-Gillette and Bruno Vellas It is published in the Journal of Alzheimer's Disease 16:3 (March 2009).

Source: Astrid Engelen

Since the 1992 campaign by the American Academy of Pediatrics, many parents have been placing babies on their backs to sleep, as it is believed to reduce the risk of sudden infant death syndrome (SIDS). As a result, there has been a 40% reduction in the incidence of SIDS. At the same time, there has been a noted increase in the incidence of DP, affecting as many as one in six infants, which may be connected with the change to the supine sleeping position in children. DP, however, can also occur with prone positioning as well.

Many researchers have published reports of risk factors for the development of DP, which include supine positioning, firstborn infants, prematurity, developmental delay and others. While these variables seem to be associated to some extent with the development of DP, the influence of each of those variables on the degree of asymmetry in DP has not been determined to date. With this in mind, physician researchers from Hasbro Children's Hospital and Children's Hospital Boston developed a study to determine the relationship between predisposing factors for DP and the severity of the flattening.

The researchers looked at a number of factors in the infants as well as maternal variables associated with pregnancy. Of particular note in their findings is the severity of flattening was not associated with infant sleep position.

Albert Oh, MD, who is also a professor of surgery at the Warren Alpert Medical School of Brown University, says, "We found a trend toward less flattening in infants who slept prone, or in positions that were alternated. Interestingly, however, while supine positioning has been a well established risk factor for the development of plagiocephaly, we were not able to demonstrate a logical correlation to indicate more severe flattening from the supine position."

In addition, the researchers identified a relationship between gestational age and the severity of the flattening, where a lower gestational age was associated with more severe flattening. Their findings also indicate that boys in the study had significantly more cranial asymmetry than girls, and their data also indicated that males are at a higher risk for more several flattening. Also of note, the researchers found no association between the use of orthotic devices and the severity of cranial flattening, calling into question the effectiveness of the use of such devices in the treatment of or prevention of DP.

The researchers also found a link between multiple-birth pregnancies and the degree of cranial asymmetry. Oh notes, "In our study, infants with DP who were the product of a multiple-birth pregnancy were disproportionately higher than in the general population and greater than in previous studies. This was the only pregnancy-related variable we found to be associated with the severity of DP of the eight different variables we assessed."

Oh says, "This study is significant because we were able to find direct correlations between a variety of variables and the severityof DP in infants. Ultimately we have shown that there are certain clear risk factors for more severe flattening in infants."

Their findings also concur with other reports, supporting the widely accepted belief that the development of plagiocephaly is progressive, beginning during early infancy. The researchers also report that maternal demographics had little effect on the severity of DP.

For the study, infants referred to Hasbro Children's Hospital and Children's Hospital Boston for DP between January 2006 and December 2007 were recruited. Parents completed a questionnaire and a focused physical exam was performed, which included a measurement of the difference in oblique cranial lengths, known as the transcranial difference. Out of the 576 with cranial asymmetry who were prospectively enrolled, 142 were excluded, leaving 434 patients with DP enrolled in the study. There were twice as many male as female infants, and the mean gestational age was 36.5 weeks. The mean age at presentation to the craniofacial programs at the hospitals was 5.8 months. Eight-three percent of the infants were reported to have a head positional preference, with 42.6 percent of those infants diagnosed with torticollis (the head leans to one side due to contracted neck muscles on that side) as the reason for the head positional preference. Nearly all of the infants (97.5 percent) in the study appeared to be developmentally normal.

Notes:

Other physician researchers involved in the study with Albert Oh are Erik Hoy, MD, also of Hasbro Children's Hospital, and Gary Rogers, MD, JD, MBA, MPH, of Children's Hospital Boston. source : health news

Wine drinkers rejoice, your favorite glass of red or white may actually help you lower your risk of developing esophageal cancer, which is one of the deadliest and fastest growing cancers in the United States. The rates of esophageal cancer have increased over the last three decades, due to a more than 500 percent increase of esophageal adenocarcinoma, a subtype of the cancer that is linked to acid reflux disease. But beware overdoing it, as alcohol abuse is a known risk factor for... another type esophageal cancer, squamous cell esophageal cancer.

The findings from three newly published studies suggest that drinking wine in moderation may actually help protect against esophageal adenocarcinoma or a precancerous condition known as Barrett’s esophagus. All three of these new studies will appear in the March issue of the journal Gastroenterology.

In one of these studies, researchers from the Kaiser Permanente division of research in Oakland, California reported that drinking as little a one glass of wine daily was associated with approximately a 56 percent decrease in the risk for developing Barrett’s esophagus. About 5 percent of the population in the U.S. is estimated to have Barrett’s, most of them are never diagnosed. People that do have the condition have about a 30 to 40 fold higher risk of developing esophageal adenocarcinoma than the rest of the general population.

The study done in California is the largest ever to examine the connection between the condition and the consumption of alcohol. The researchers examined data from a larger trial that included detailed, self-reported information about alcohol consumption. The study included 320 people who were diagnosed with Barrett’s esophagus between the years 2002 and 2005, 316 people that had gastro-esophageal reflux disease (GERD) without Barrett’s, and 317 people that did not have Barrett’s or GERD. Even after the researchers controlled the risk factors for Barrett’s, the moderate wine consumption appeared to be protective.

Douglas A. Corley, the gastroenterologist and principal investigator at Kaiser Permanente, said, “We found no relationship between overall alcohol consumption and Barrett’s esophagus, but the risk of developing Barrett’s was lower among wine drinkers.”

In the second study, researchers in Australia examined patients drinking histories that had both types of esophageal cancer. During the study, the researcher found that:
 As to be expected, heavy alcohol consumption was associated with an increased risk of developing squamous cell cancer of the esophagus.
 There was no association seen between the amount of alcohol the patient consumed and esophageal adenocarcinoma.
 It was found that the moderate consumption of wine or spirits (no more than one drink daily) was associated with a lower risk for developing both cancers in comparison to nondrinkers.

In the third study conducted, researchers from Belfast examined the impact of the consumption of alcohol on GERD-related esophagitis, esophageal adenocarcinoma, and Barrett’s esophagus. The researchers found that there was no increase in risk associated with drinking alcohol in early adulthood for any of the three conditions. However, their findings do suggest that wine may lower the risk of reflux esophagitis, esophageal adenocarcinoma, and Barrett’s esophagus.

All of the studies suggest, but do not prove, that drinking wine in moderation protects against Barrett’s and esophageal adenocarcinoma. Corley stated that if wine is protective, the benefits may have nothing at all to do with the alcohol. “Wine is high in antioxidants and other studies have shown that people who eat plenty of antioxidant-rich fruits and vegetables are less likely to have Barrett’s esophagus and esophageal cancer,” he says.
In studies done with animals, antioxidants have also been shown to help protect against the inflammation that causes injury to the esophagus.

Because there are so many questions that are still unanswered, Corley says it is still far too soon to recommend drinking a glass of wine every day to protect against esophageal cancer. He stated that at this time the best we can say is that alcohol does not seem to be a risk factor for esophageal adenocarcinoma and Barrett’s.

One of Barrett’s researchers, Prateek Sharma, M.D. from the University of Kansas School of Medicine, agrees, saying, “It may be that people who drink wine have healthier lifestyles. They may eat more fruits and vegetables and consume less fat in their diets, The last thing you would want is for people to start drinking wine to prevent cancer.”

Even though esophageal adenocarcinoma is the fastest growing cancer today in the United States, Sharma points out that it is still relatively uncommon. Approximately 15,000 people in the United States are diagnosed with esophageal cancer annually, compared with the 150,000 that are diagnosed with colon cancer annually.source medical updates

Multiple sclerosis (MS) affects about 400,000 Americans and approximately 2.5 million people worldwide, according to the National Multiple Sclerosis Society. It is a chronic and often disabling disease that attacks the brain, spinal cord, and optic nerves that make up the central nervous system. Symptoms can range from... numbness in the limbs to debilitating paralysis and loss of vision. The symptoms, as well as the progression and severity of MS, are unpredictable and may vary greatly from one person to another.

MS is an autoimmune disease in which the body’s own defense system attacks a fatty substance called myelin that surrounds and protects the nerve fibers in the central nervous system. The damaged myelin forms scar tissue, or sclerosis. Nerve fibers can be damaged as well. MS patients suffer from a progressive decline in mobility and few treatment options are available beyond physical therapy. However, a new drug developed by Acorda Therapeutics Incorporated, known as fampridine, has now been shown to improve walking ability in some multiple sclerosis patients. The report on the analysis was published in The Lancet.

Andrew Goodman of the University of Rochester Medical Center in New York, and colleagues, conducted the phase III study of 301 patients ranging in age from18 to 70. Participants were randomly selected to receive either 10 milligrams of fampridine or a placebo twice daily for a period of 14 weeks. Assessments were made of the participants’ walking speeds for a distance of 25 feet after periods of two weeks, six weeks, 10 weeks and 14 weeks.

The results of the study revealed that 35 percent of the participants who received fampridine achieved a faster walking speed in a minimum of three of the four assessments compared to only 8 percent of those taking placebo. In addition, those participants taking the fampridine showed greater improvement in leg strength, improving their ability to participate in daily activities such as standing, walking outside, and using stairs.

A total of 5 percent of the participants withdrew from the study due to adverse events including two participants suffering from the severe adverse events of focal seizure and severe anxiety in connection with use of the drug. The researchers noted that in previous studies, the risk of seizure appeared to increase in accordance with dosage of fampridine.

In conclusion, the researchers wrote, “Treatment with fampridine produces clinically meaningful improvement in walking ability in some people with multiple sclerosis, irrespective of disease course type or concomitant treatment with immunomodulators.” The team also noted that more research would be necessary to confirm the study findings.

There is no known cure for MS. According to Goodman, existing drugs target slowing the progression of the disease and helping to prevent relapses, although patients may not be able to tell whether or not they are working. He explained that with fampridine pills, the patients know if it is working.

In a statement, Dr. Ron Cohen, president and CEO of Acorda Therapeutics, said, “This trial included both physician and patient assessment scales that demonstrated both improvement in walking speed and clinical meaningfulness of that improvement.” He went on to say, “The results of this study indicate that fampridine-SR could potentially represent an important new treatment option in managing MS.”

Although fampridine has shown success in the improvement of visual function, strength, walking ability, fatigue and endurance in MS patients, concerns remain as to the safety and effectiveness of the drug. Acorda submitted a new drug application for fampridine to the U.S. Food and Drug Administration on January 30th. If approved, it would be the first MS drug to reverse a symptom of the disease. source medical updates

Stem cell therapy has become the subject of huge interest and vigorous debates. Promoters believe stem cells offer great promise for new medical treatments to combat cancer, diabetes, Alzheimer’s and other regenerative diseases, while the opposition argues that research on embryos—the prime source of the most versatile stem cells, pluripotent—destroys human life. In the past year, scientists have found genes that... can transform ordinary skin cells into cells that look and act like embryonic stem cells, eliminating the use of an embryo, and the ethical concerns. The downside is that delivery of these genes requires the use of a virus, raising concerns the cells could cause tumors or other effects if placed in a patient. Now, researchers say they have discovered a new method of transporting the genes without the use of such potentially harmful viruses, thereby overcoming a major hurdle for safe, personalized stem cell therapies in the future.

In the new work, researchers in Toronto and at the University of Edinburgh instead used a piece of DNA called a transposon, which can insert itself into an organism’s DNA and carry a cargo with it, to deliver four specific genes. In this case, the transposon version used is called “piggyBac,” which has been used to genetically modify a range of organisms. After the conversion, the added DNA was removed from the transformed cells with a specific enzyme. The researchers used the technique in both mouse and human skin cells and found the reprogrammed cells—iPS cells—behaved just like embryonic stem cells. “PiggyBac carries the four genes into the cells and reprograms the cells into stem cells. After they have reprogrammed the cells, they are no longer required, and in fact they are dangerous,” explains Dr. Andras Nagy, senior investigator at the Samuel Lunenfeld Research Institute of Mount Sinai Hospital in Toronto, Canada. “After they do their job they can be removed seamlessly, with no trace left behind. The ability for seamless removal opens up a huge possibility.”

In 2005, Nagy created Canada’s first embryonic stem cell lines from donated embryos no longer required for reproduction by couples undergoing fertility treatment; research that played a pivotal role in his current discovery. One of the critical components reported in Nagy’s paper, published in the March 1, 2009 issue of Nature, was developed in the laboratory of Dr. Keisuke Kaji from the Medical Research Council (MRC) Center for Regenerative Medicine in Edinburgh, Scotland. “I was very excited when I found stem cell-like cells in my culture dishes. Nobody, including me, thought it was really possible,” Kaji said. “It is a step towards the practical use of reprogrammed cells in medicine, perhaps even eliminating the need for human embryos as a source of stem cells.”

“It’s very exciting work,” said Robert Lanza, a stem cell researcher at Advanced Cell Technology in Worcester, Massachusetts. “With the new work, we’re only a hair’s breadth away from the biggest prize in regenerative medicine—a way to create patient-specific cells that are safe enough to use clinically.”

Other scientists, however, while crediting the work as an important advance, say it remains crucial to continue work on both types of cells. “The point is, we don’t know yet what the end potential of either of these approaches will be,” said Mark A. Kay of Stanford University. “No one has cured any disease in people with any of these approaches yet. We don’t know enough yet to know which approach will be better.”

In 2001, President George W. Bush restricted federal funding for human embryonic stem cell research to prevent taxpayer money from encouraging the destruction of human embryos, which is necessary to obtain pluripotent cells. However, Senators Tom Harkin, an Iowa Democrat, and Arlen Specter, a Republican from Pennsylvania, have reintroduced a Senate bill that would allow federal funding for research using stem cells taken from human embryos left over from fertility treatments. “For too long, political interference has delayed research that holds the promise for millions of Americans who suffer from a wide range of diseases,” Harkin said in a statement. “President Obama has promised to lift the restrictions on embryonic stem cell research that were put in place by President Bush, and I hope and expect that he will do so soon, but we have to make sure that the freedom to pursue this research is also protected by federal law, not merely by an executive order that can be reversed during a future administration.” source : Medical updates

In medical school, I thought it was fascinating that electroconvulsive therapy (ECT) was useful in severe depression which was resistant to other treatments. Those memories resurfaced as I was prompted by a recent Wall Street Journal article to read an article in the journal Neuropsychopharmacology which described research showing a vagus nerve stimulator (VNS) having similar promise in treatment-resistant depression.

Who would know what would be disclosed, that every author had an undisclosed financial relationship with the... device manufacturer, Cyberonics:

Ronnie Wilkins, the executive director of the medical society that publishes Neuropsychopharmacology, says that the consulting arrangements should have been disclosed and that a correction will be published as soon as possible. He says the authors did report their financial relationships with the company in forms they are required to fill out as part of the publication process. However, he says the consulting information was not included in the manuscript of the review piece as required.



It will be interesting to see what the fallout is regarding the editor of that journal having also been an author of the article in dispute. Cyberonics tries to show it had no influence by granting an unrestricted grant to undertake the research. But the article should have clearly stated the financial arrangements -- curious how that escaped publication.

Electroconvulsive therapy has long been practiced as effective treatment for severe depression and psychotic depression. According to the Nature paper, in 2001 the FDA approved VNS as an alternative to electroconvulsive therapy which lacked evidence of long-term benefit and side effects. Since then, a limited number of patients have been studied, not many more than those reviewed by the Technology Evaluation Center of the Blue Cross Blue Shield Association in August 2005 (TEC).

At that time, the TEC stated that the "available evidence is not sufficient to permit conclusions of the effect of VNS therapy on health outcomes." Specific concerns included the study's definition of treatment-resistant depression and the lack of statistical significance of the results. Some providers define treatment-resistant depression as patients having failed to improve after 6 weeks of therapy on 2 medications, but others allow for a total of 10 to 12 weeks [1]. By defining it with this shorter duration, possibly less severely affected patients were included in the trial. What a lack of statistical significance means is that by the study's numbers you can't be sure that this treatment helped.

Sounds like ECT will continue to be used in severe depression for some time, until these ethical quandries are cleared up and more studies are done.

References:
1. Nemeroff CB. Augmentation strategies in patients with refractory depression. Depress Anxiety 1996-97;4:169-81

WebOps LLC. has announced that Atlanta-based Peak Medical, Inc., an independent distributor of Wright Medical’s orthopaedic products, has selected the WebOps Logistics web-based solution to manage their medical device inventory and surgical case load to ensure that needed implants and devices are accurately and efficiently available in the operating room.

“We believe we’ve found a business solution that will take our company to... the next level,” says Shawn Fobas, co-principal of Peak Medical. “Putting WebOps Logistics in the hands of our sales force and our backend operation personnel will allow us to substantially increase productivity and conduct business with much greater efficiency.”

WebOps Logistics is the industry's first medical device logistics application that brings true mobility and connectivity to an entire enterprise. It is a secure, web-based solution that manages the entire logistics cycle - from initial case planning to purchase order to replenishment - and offers up-to-the-minute schedules, case requirements and inventory usage at a glance. Moreover, the system requires no client-side software and is extremely user-friendly. With WebOps Logistics, everyone is connected - via BlackBerry, Palm or PC, in real time: sales, warehouse, purchasing, customer service, inventory, management, medical staff and customer service.

“Our solution is one that is mission-critical for medical professionals,” says Joe Carlson, VP of Operations and Customer Support, WebOps, LLC. “We see tremendous opportunity to enhance the productivity of medical device companies and we’re dedicated to exploring the ways technology can be leveraged to meet those needs.”

About Peak Medical, Inc.
Peak Medical is an independent distributor of Wright Medical - a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics.

About WebOps
WebOps, LLC provides integrated, real-time logistics solutions for the medical device industry. WebOps Logistics™, the company's flagship solution, provides real-time, web-based connectivity and coordination for logistics, sales support and operations – via BlackBerry, Palm or PC. The solution has been implemented by leading medical device distributors since 2005 and successfully manages over 50,000 surgeries per year. For more information klik here todays medical

The Pediatric Medical Device Institute (PMDI), an organization aimed at the development of innovative medical devices for children, has recently expanded its capabilities to include advanced R&D and manufacturing expertise with the addition of high-tech engineering firm Schultz-Creehan LLC to its list of corporate sponsors. Charged by a special stakeholders committee mandated by Congress, PMDI was founded to overcome current barriers faced by the pediatric medical device industry such as costs, small market size, and... lack of collaborative networks by providing information to hospitals, companies, and the educational community.

Through their expertise in developing innovative solutions for industry, Schultz-Creehan is able to overcome many of these barriers with their advanced capabilities and experience in precision machining at the micro scale, conceptual design, mechanical design, CAD/CAM, prototype fabrication, and small scale manufacturing. Schultz-Creehan designs and manufacturers medical device components for industry and has partnered with organizations such as Virginia Bioinformatics Institute and Virginia Tech on bio-engineering projects.

“Schultz-Creehan is privileged to work alongside PMDI and its consortium of children’s hospitals to improve the quality of medical care for children,” says Nanci Hardwick, CEO. ”We look forward to assisting PMDI in overcoming the complex challenges faced by the pediatric medical device industry.”

About the Pediatric Medical Device Institute (PMDI): PMDI is for infants and children who have unmet needs for medical devices to improve the quality of their care, the PMDI utilizes an innovative approach to product development. Unlike the current market driven device development process, the needs-based PMDI invests professional effort and/or funds at specific points in the product development life-cycle in order to create devices at an accelerated pace, thus overcoming many barriers inherent in the traditional model. For more information about PMDI