FDA Approves Multaq(R) For Patients With Atrial Fibrillation Or Atrial Flutter

Posted by admin on Julio 3rd, 2009 under pharma industry
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Sanofiaventis (EURONEXT SAN and NYSE SNY) announced that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq(R) is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.

Multaq(R) is an antiarrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction [LVEF]

Treatment That Significantly Slows Progression Of Eye Damage In Persons With Type 1 Diabetes - University Of Minnesota

Posted by admin on Julio 3rd, 2009 under diabetes
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University of Minnesota Medical School researcher Michael Mauer, M.D., has found a treatment that significantly slows the progression of eye injury in people with type 1 diabetes, a common complication caused by this disease. By administering an antihypertensive, medication commonly prescribed to treat high blood pressure, Mauer and colleagues were able to slow progression of diabetic eye damage in more than 65 percent of participants involved in the study.

Diabetes is the primary cause of acquired blindness in adults and accounts for nearly half of all new cases of chronic kidney failure in the Unites States each year, and people living with the disease often struggle with these complications as it progresses. Previous studies of people with type 1 diabetes who were already exhibiting symptoms of vision and kidney function loss showed that these types of antihypertensive medications slowed further function loss in the kidneys, but often could not prevent kidney failure. Mauer and colleagues were interested in testing whether or not they could delay diabetic kidney injury in participants who had normal blood pressure and had not yet shown signs of kidney disease at the beginning of the study.

Three groups of participants were observed over the course of five years. Two groups were administered one of two antihypertensive medications, losartan or enalapril, and the last group, a placebo. The results were unexpected, but conclusive. Mauers study demonstrated that these drugs did not protect the participants kidneys from damage or from losing function. However, participants who were administered either enalapril or losartan experienced a significant slowing of the progression of diabetic eye injury, by 65 and 70 percent, respectively.

“The secondary results of this study showed that people taking these antihypertensive medications experienced a substantially positive effect in slowing diabetic eye injury,” said Mauer, professor of pediatrics and medicine in the Medical School. “Although neither medication delayed early kidney tissue injury or early loss of kidney function, the advantage to a study with negative findings such as this one is that physicians now know that this treatment is ineffective for this purpose, and they can pursue other treatment options that may improve their patients outcomes.”

Although the data does not support the use of these types of antihypertensives to prevent kidney damage in people living with diabetes, Mauer and colleagues find it reasonable for physicians to consider prescribing these classes of medication to people with type 1 diabetes in order to slow the onset and progression of diabetic eye disease. He notes, though, that this also poses several other unanswered questions such as at what age a person with diabetes should be prescribed this class of drug and how long they should continue taking it.

Mauers study “Renal and Retinal Effects of Enalapril and Losartan in Type 1 Diabetes” is published in the July 2nd issue of The New England Journal of Medicine. An editorial accompanies the article.

The study was supported by research grants from the National Institutes of Health (National Institute of Diabetes and Digestive and Kidney Diseases), Merck (in the United States), Merck Frosst (in Canada), and the Canadian Institutes of Health Research.

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Nick Hanson

History Of Periodontitis Linked To Cerebrovascular Disease In Men

Posted by admin on Julio 2nd, 2009 under mens health
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The potential role of periodontitis, an inflammatory disease of the gums, in the risk of cardiovascular disease, particularly ischemic stroke, has received growing attention during the last decade. A new study is the first prospective cohort study to use clinical measures of periodontitis to evaluate the association between this disease and the risk of cerebrovascular disease. The study is published in Annals of Neurology, the official journal of the American Neurological Association

Led by Thomas Dietrich of the University of Birmingham School of Dentistry, and Elizabeth Krall of the Boston VA and the Boston University School of Dental Medicine, the study analyzed data from 1,137 men in the VA Normative Aging and Dental Longitudinal Study, an ongoing study begun in the 1960s with healthy male volunteers from the greater Boston area. A trained periodontist conducted dental exams every three years that included full mouth Xrays and periodontal probing at each tooth. Cerebrovascular disease was defined as a stroke or transient ischemic attack (TIA) and followup lasted an average of 24 years.

The results showed a significant association between periodontal bone loss and the incidence of stroke or TIA, independent of cardiovascular risk factors. This association was much stronger among men younger than 65 years old.

There are several possible pathways that could explain the association found in the study. There could be direct or indirect effects of the periodontal infection and the inflammatory response, or some people may have an increased proinflammatory susceptibility that could contribute to both cerebrovascular disease and periodontal disease.

The study found that only periodontal bone loss, which would indicate a history of periodontal disease, not probing depth, which would indicate current inflammation, was associated with the incidence of cerebrovascular disease. Also, the stronger association in younger men seen in this and other studies may indicate a proinflammatory susceptibility in some men that is reflected in periodontal destruction at a younger age.

The authors note that if periodontitis caused cerebrovascular disease, it could be an important risk factor, given its relatively high prevalence and the strength of the association in younger men. It is also possible that people with periodontitis may pay less attention to health in general (e.g., they may not take medications as regularly). The authors conclude “Large epidemiologic studies using molecular and genetic approaches in various populations are necessary to determine the strength of the association between periodontitis and cerebrovascular disease and to elucidate its biologic basis.”

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Sean Wagner

Daily Sex Helps To Reduce Sperm DNA Damage And Improve Fertility

Posted by admin on Julio 1st, 2009 under sexual health
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Daily sex (or ejaculating daily) for seven days improves mens sperm quality by reducing the amount of DNA damage, according to an Australian study presented to the 25th annual meeting of the European Society of Human Reproduction and Embryology in Amsterdam.

Until now there has been no evidencebased consensus amongst fertility specialists as to whether or not men should refrain from sex for a few days before attempting to conceive with their partner, either spontaneously or via assisted reproduction.

Dr David Greening, an obstetrician and gynaecologist with sub specialist training in reproductive endocrinology and infertility at Sydney IVF, Wollongong, Australia, said “All that we knew was that intercourse on the day of ovulation offered the highest chance of pregnancy, but we did not know what was the best advice for the period leading up to ovulation or egg retrieval for IVF.

“I thought that frequent ejaculation might be a physiological mechanism to improve sperm DNA damage, while maintaining semen levels within the normal, fertile range.”

To investigate this hypothesis, Dr Greening studied 118 men who had higher than normal sperm DNA damage as indicated by a DNA Fragmentation Index (DFI). Men who had a more than 15% of their sperm (DFI >15%) damaged were eligible for the trial. At Sydney IVF, sperm DNA damage is defined as less than 15% DFI for excellent quality sperm, 1524% DFI for good, 2529% DFI for fair and more than 29% DFI for poor quality; but other laboratories can have slightly different ranges.

The men were instructed to ejaculate daily for seven days, and no other treatment or lifestyle changes were suggested. Before they started, levels of DNA damage ranged between 15% and 98% DFI, with an average 34% DFI when measured after three days abstinence. When the mens sperm was reassessed on the seventh day, Dr Greening found that 96 men (81%) had an average 12% decrease in their sperm DNA damage, while 22 men (19%) and an average increase in damage of nearly 10%. The average for the whole group dropped to 26% DFI.

Dr Greening said “Although the mean average was 26% which is in the fair range for sperm quality, this included 18% of men whose sperm DNA damage increased as well as those whose DNA damage decreased. Amongst the men whose damage decreased, their average dropped by 12% to just under 23% DFI, which puts them in the good range. Also, more men moved into the good range and out of the poor or fair range. These changes were substantial and statistically highly significant.

“In addition, we found that although frequent ejaculation decreased semen volume and sperm concentrations, it did not compromise sperm motility and, in fact, this rose slightly but significantly.

“Further research is required to see whether the improvement in these mens sperm quality translates into better pregnancy rates, but other, previous studies have shown the relationship between sperm DNA damage and pregnancy rates.

“The optimal number of days of ejaculation might be more or less than seven days, but a week appears manageable and favourable. It seems safe to conclude that couples with relatively normal semen parameters should have sex daily for up to a week before the ovulation date. In the context of assisted reproduction, this simple treatment may assist in improving sperm quality and ultimately achieving a pregnancy. In addition, these results may mean that men play a greater role in infertility than previously suspected, and that ejaculatory frequency is important for improving sperm quality, especially as men age and during assisted reproduction cycles.”

Dr Greening said he thought the reason why sperm quality improved with frequent ejaculation was because the sperm had a shorter exposure in the testicular ducts and epididymis to reactive oxygen species very small molecules, high levels of which can damage cells. “The remainder of the men who had an increase in DFI might have a different explanation for their sperm DNA damage,” he concluded.

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Mary Rice
European Society for Human Reproduction and Embryology

Finding The Best Heart Disease And Stroke Treatments For Patients With Diabetes Using New Tool

Posted by admin on Junio 30th, 2009 under diabetes
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Researchers from North Carolina State University and Mayo Clinic have developed a computer model that medical doctors can use to determine the best time to begin using statin therapy in diabetes patients to help prevent heart disease and stroke.

“The research is significant because patients with diabetes are at high risk for cardiovascular disease and statins are the single most commonly used treatment for patients at risk of heart disease and/or stroke,” says Dr. Brian Denton, “and this model can help determine the best course of action for individual patients based on their risk of developing cardiovascular disease.” Denton is an assistant professor in NC States Edward P. Fitts Department of Industrial & Systems Engineering and lead author of the study.

Statins are a key component of current cardiovascular medical treatment guidelines, Denton says. They lower cholesterol levels and may significantly reduce the risk of heart attack and stroke, particularly in patients that are considered to be at high risk.

The researchers developed a new mathematical model that examines various possible treatment policies to see how they influence shortterm and longterm health outcomes for patients. The model shows how people are affected by diabetes, and how their health changes over time as the disease advances and patients age.

The new model incorporates patientspecific data. An established risk model calculates each patients probability of heart attack and stroke based on risk factors, such as their cholesterol, blood pressure, etc. This overall risk “score” is used to weigh the medical advantages of beginning statin therapy against the financial cost of the statins.

Overall, by accounting for the progression of diabetes, the patients specific risk score and the costbenefit analysis, the new model may help patients and doctors decide on the optimal time to begin statin therapy.

Denton says the new model has not yet been put into practice, but that the research team plans to develop a pilot to put the tool into the hands of medical professionals.

The research, “Optimizing the Start Time of Statin Therapy for Patients with Diabetes,” was funded in part by the Agency for Healthcare Research and Quality and the National Science Foundation, and was published earlier this month in the journal Medical Decision Making. The research was coauthored by Denton from NC State; Nilay D. Shah, Sandra C. Bryant and Steven A. Smith of the Mayo Clinic College of Medicine; and University of Pittsburgh graduate student Murat Kurt.

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Matt Shipman

Takeda Receives FDA Complete Response Letter For Alogliptin, An Investigational Treatment For Type 2 Diabetes

Posted by admin on Junio 30th, 2009 under diabetes
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Takeda Pharmaceutical Company Limited (”Takeda”) announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Companys New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.

As previously announced on March 6, 2009, the FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance titled, “Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance.

“Takeda will continue to promote key initiatives in order to realize sustained growth from a medium to longterm perspective,” said Takeda President & CEO, Yasuchika Hasegawa.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a researchbased global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions.

Cancer Risk May Be Greater With Insulin Analogue Glargine

Posted by admin on Junio 29th, 2009 under diabetes
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The risk of cancer possibly increases if patients with diabetes use the longacting insulin analogue glargine instead of human insulin. The Institute for Quality and Efficiency in Health Care (IQWiG), in collaboration with the “Wissenschaftliches Institut der AOK” (WIdO), the research institute of the German Local Health Care Fund, analysed the data of almost 130,000 patients with diabetes in Germany who had been treated with either human insulin or the insulin analogues lispro (trade name Humalog), aspart (Novorapid) or glargine (Lantus) between January 2001 and June 2005.

The analysis has now been published together with further studies in the scientific journal Diabetologia, the official organ of the European Association for the Study of Diabetes (EASD).

The disturbing result is that malignancies were found more frequently in patients treated with glargine than in those prescribed a comparable dose of human insulin. “Our analysis does not provide absolute proof that glargine promotes cancer,” says Peter T. Sawicki, IQWiGs Director and coauthor of the study. “Our study does, however, arouse an urgent suspicion which should have consequences for the treatment of patients.”

No difference was found between the shortacting insulin analogues, lispro and aspart, and human insulin. Insulin analogues are synthetic molecules that do not occur naturally, whereas human insulin matches the insulin that the human body manufactures itself.

Is glargine the cause?

IQWiG emphasises that the link found between prescribing glargine and an increased cancer risk is a statistical association. Thus, it is possible that other factors as yet unknown are the cause of the increased risk, rather than glargine. However, it is disturbing that of three further studies published in the same edition of Diabetologia, two also describe an increase in cancer risk associated with glargine.

Glargine has been approved in Germany since 2000. Since then, several laboratory trials have been published which indicate that, under certain conditions, insulin analogues can stimulate the growth of cancer cell lines more strongly than human insulin. “These indications are discussed in the scientific world but have never been dispelled by proper studies,” says Sawicki. According to IQWiG, the overall indications of a risk from glargine have now intensified to such an extent that the burden of proof has been reversed for precautionary reasons as long as reliable studies do not prove the safety of glargine compared to human insulin, the drug should only be used if there are particularly important reasons for doing so.

Risk of disease increases with dose

The researchers also found that the risk of cancer rose further with increasing glargine dose when compared to human insulin. This dosedependent relationship with glargine also confirms the suspicion that the drug plays a causal role.

The increase in cancer risk was relatively small and was only detected when other, important factors such as age, sex and daily insulin dose were taken into consideration. The patients were on average between 65 and 70 years of age, thus in principle were already exposed to a certain degree of cancer risk. Out of 1000 patients treated with human insulin, about 41 developed malignancies within an average of 20 months. If “similar” patients were to be treated with glargine, the increases in cancer diagnoses would be as follows in patients prescribed on average 10 glargine units daily, about 4 more patients per 1000 patients would develop cancer. In patients prescribed 50 glargine units daily, about 13 more patients per 1000 patients would develop cancer.

However, according to the German Local Health Care Fund data, most patients used glargine in relatively low doses. Of 100 patients using glargine, about 50 patients used less then 20 units daily, and only 5 of 100 patients used more than 50 units daily.

Dont change treatment hastily

However, the latest investigation is no reason for patients with diabetes to change their treatment hastily, especially if the glargine dose used is low. Diabetes is a complex disease and many aspects need to be considered in its treatment. “However, if a patient can be treated equally well with human insulin as with glargine, then, after consultation with his or her doctor, the patient should consider changing to human insulin,” states Sawicki. “If at all possible, patients with an increased risk of cancer should use human insulin instead of glargine.”

The researchers have no evidence that glargine or other insulin agents transform normal cells to cancer cells. However, it may be possible that glargine stimulates the growth of existing cancer cells more strongly than other types of insulin.

In their study, IQWiG and WIdO had access to pseudonymous data on disease and invoices for 17.9 million insurants of the AOK, of which over 320,000 patients had diabetes (particularly type 2). The data were evaluated of approximately 130,000 patients with diabetes who had used either human insulin or an insulin analogue exclusively, and who had not developed malignancies up to 2001.

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Dr. AnnaSabine Ernst

What Is Polio (poliomyelitis)? What Causes Polio?

Posted by admin on Junio 26th, 2009 under aid disasters
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Polio, or poliomyelitis, is a highly contagious viral infection that can lead to paralysis, breathing problems, or even death. The term poliomyelitis is from the Greek poliós meaning “grey”, myelós referencing the spinal cord, and itis meaning inflammation.

Polio can be classified as either symptomatic or asymptomatic. About 95% of all cases display no symptoms (asymptomatic polio), and between 4% and 8% of cases display symptoms (symptomatic polio). Symptomatic polio can be broken down further into a mild form called nonparalytic or abortive polio and a severe form called paralytic polio (occurring in 0.1% to 2% of cases).

Paralytic polio also may be classified asSpinal polio attacks motor neurons in the spinal cord and causes paralysis in arms and legs and breathing problems
Bulbar polio affects neurons responsible for sight, vision, taste, swallowing, and breathing
Bulbospinal polio both spinal and bulbar polioMany people with nonparalytic polio are able to make a full recovery, while those with paralytic polio generally end up with permanent paralysis.Who gets polio? Like many other infectious diseases, polio victims tend to be some of the most vulnerable members of the population. This includes the very young, pregnant women, and those with immune systems that are substantially weakened by other medical conditions. Anyone who has not been immunized against polio is especially susceptible to contracting the infection.

Additional risk factors for polio include traveling to places where polio is endemic or widespread, living with someone infected with polio, working in a laboratory where live poliovirus is kept, and having your tonsils removed.What causes polio? Polio is caused by the poliovirus, a highly contagious virus specific to humans. The virus usually enters the environment in the feces of someone who is infected. In areas with poor sanitation, the virus easily spreads through the fecaloral route, via contaminated water or food. In addition, direct contact with a person infected with the virus can cause polio. What are the symptoms of polio? Polio, in its most debilitating forms, displays symptoms such as paralysis and death. However, most people with polio dont actually display any symptoms or become noticeably sick. When symptoms do appear, there are differences depending on the type of polio.

Nonparalytic polio (abortive poliomyelitis) leads to flulike symptoms that last for a few days or weeks, such as fever, sore throat, headache, vomiting, fatigue, back and neck pain, arm and leg stiffness, muscle tenderness, muscle spasms, and meningitis.

Paralytic polio will often begin with symptoms similar to nonparalytic polio, but will progress to more serious symptoms such as a loss of muscle reflexes, severe muscle pain and spasms, and loose or floppy limbs that is often worse on one side of the body.How is polio diagnosed? Polio is often recognized because of symptoms such as neck and back stiffness, abnormal reflexes, and trouble with swallowing and breathing. A physician who suspects polio will perform laboratory tests that check for poliovirus using throat secretions, stool samples, or cerebrospinal fluid.How is polio treated? There is no cure for polio once a person becomes infected. Therefore, treatments are focused on increasing comfort, managing symptoms, and preventing complications. This may include providing bed rest, antibiotics for additional infections, pain killers, ventilators to help breathing, physiotherapy and moderate exercise, and a proper diet.

One treatment for lung paralysis due to polio was to place the patient into an iron lung a device that would push and pull chest muscles to make them work. However, more modern portable ventilators and jackettype ventilators are now employed.How can polio be prevented? Although polio essentially has been eradicated in the US since 1979 and in the Western Hemisphere since 1991, children and adults in Afghanistan, India, Nigeria, and Pakistan are still contending with the disease. There are two vaccines available to fight polio inactivated poliovirus (IPV) and oral polio vaccine (OPV).

IPV, which consists of a series of injections beginning two months after birth and continuing until a child is 4 to 6 years old, is provided to most children in the United States. The vaccine is created from inactive poliovirus, but it is very safe and effective and cannot cause polio. OPV is created from a weakened or attenuated form of poliovirus, and it is the vaccine of choice in many countries because of its low cost, ease of administration, and ability to provide excellent immunity in the intestine. OPV, however, has been known to revert to a dangerous form of poliovirus that is able to paralyze its victim.

Polio vaccinations or boosters are highly recommended in anyone who is not vaccinated or is unsure if she is vaccinated.

New Mechanism For Amyloid Beta Proteins Toxic Impact On The Alzheimers Brain

Posted by admin on Junio 26th, 2009 under alzheimers
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Scientists have uncovered a novel mechanism linking soluble amyloid β protein with the synaptic injury and memory loss associated with Alzheimers disease (AD). The research, published by Cell Press in the June 25 issue of the journal Neuron, provides critical new insight into disease pathogenesis and reveals signaling molecules that may serve as potential additional therapeutic targets for AD.

Amyloid β protein (Aβ) plays a major pathogenic role in AD, a devastating neurodegenerative disorder characterized by progressive cognitive impairment and memory loss. “Given the mounting evidence that small soluble Aβ assemblies mediate synaptic impairment in AD, elucidating the precise molecular pathways by which this occurs has important implications for treating and preventing the disease,” explains senior study author, Dr. Dennis Selkoe from the Center for Neurologic Diseases at Brigham and Womens Hospital and Harvard Medical School.

Dr. Selkoe, Dr. Shaomin Li, and colleagues examined regulation of a cellular communication phenomenon known as longterm synaptic depression (LTD). LTD has been linked with neuronal degeneration, but a role for Aβ in the regulation of LTD has not been clearly described. The researchers found that soluble Aβ facilitated LTD in the hippocampus, a region of the brain intimately associated with memory. The enhanced synaptic depression induced by soluble Aβ was mediated through a decrease in glutamate recycling at hippocampal synapses.

Excess glutamate, the major excitatory neurotransmitter in the brain, is thought to contribute to the progressive neuronal loss characteristic of AD. The researchers went on to show that Aβenhanced LTD was mediated by glutamate receptor activity and that the LTD could be prevented by an extracellular glutamate scavenger system. A very similar enhancement of LTD could be induced by a pharmacological blocker of glutamate reuptake. Importantly, soluble Aβ directly and significantly decreased glutamate uptake by isolated synapses.

“Our findings provide evidence that soluble Aβ from several sources enhances synaptic depression through a novel mechanism involving altered glutamate uptake at hippocampal synapses,” concludes Dr. Selkoe. “These results have both mechanistic and therapeutic implications for the initiation of hippocampal synaptic failure in AD and in more subtle forms of agerelated Aβ accumulation.” Future studies are needed to determine precisely how soluble Aβ protein physically interferes with glutamate transporters at the synapse.

The researchers include Shaomin Li, Brigham and Womens Hospital, Harvard Medical School, Boston, MA; Soyon Hong, Brigham and Womens Hospital, Harvard Medical School, Boston, MA; Nina E. Shepardson, Brigham and Womens Hospital, Harvard Medical School, Boston, MA; Dominic M. Walsh, University College Dublin, Dublin, Ireland; Ganesh M. Shankar, Brigham and Womens Hospital, Harvard Medical School, Boston, MA; and Dennis Selkoe, Brigham and Womens Hospital, Harvard Medical School, Boston, MA.

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Cathleen Genova

Caldera Medical Announces FDA Clearance Of Novel Treatment For Pelvic Organ Prolapse

Posted by admin on Junio 25th, 2009 under womens health
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Caldera Medical, Inc. announced that it has received FDA clearance and CE Mark certification for the Ascend Pelvic Floor Repair System with Apical Support, a novel treatment for female pelvic organ prolapse. Ascend® is the latest addition to the Caldera Medical family of products designed to treat female stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Calderas product line includes the Desara® Sling System, a universal sling that allows surgeons their choice of multiple surgical approaches by utilizing reusable instrumentation. Caldera is the only U.S. company offering this unique solution, which benefits surgeons, hospitals, and the environment.

Pelvic Organ Prolapse is one of the most common quality of life conditions facing women. In fact, nearly 50% of women who have given birth vaginally will develop this condition. Furthermore, a womans lifetime probability for undergoing a surgical treatment to correct POP is approximately 11%, and approximately 29% of surgically managed patients require reoperation due to reoccurrence of the condition. Patients with POP often present with a dual diagnosis of stress urinary incontinence, and Calderas SUI offering, Desara, can be used together in the same surgical procedure as Ascend.

Ascend introduces several key differentiators to the market. Notably, Ascend provides apical support from the anterior compartment through unique implant geometry utilizing CentraSoft™ mesh technology and a patented surgical method that is designed to both reduce invasiveness and enhance patient outcomes. CentraSoft™ mesh technology provides a thin, lightweight central mesh designed to conform to the patients anatomy with stronger lateral arms for support. For patients with both anterior and apical defects, Ascend offers the ability to treat both defects with one surgical implant, reducing the potential for complications and the cost to the healthcare system. Bryon L. Merade, CEO, commented, “We are very excited about Ascends cutting edge technology and the option it provides surgeons to treat their patients with minimally invasive techniques utilizing the fewest number of implants possible. Ascend underscores our commitment to improving womens health.”

Tomas Antonini, M.D. of Round Rock, TX, one of the nations leading urogynecologists, said, “Ascend fulfils a need surgeons have had for years for an implant that can treat both anterior compartment and apical prolapse at the same time and in the same procedure. The ability to treat these two defects with a single implant will address a common cause of failures seen in these types of repairs. Caldera has once again brought a unique technology to market in an effort to improve the treatment of pelvic organ prolapse and stress urinary incontinence.”

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