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Avinger Enrolls First U.S. PAD Patient in CONNECT II Global Clinical Trial

Posted: March 7, 2012 at 6:05 am

LITTLE ROCK, Ark. & REDWOOD CITY, Calif.--(BUSINESS WIRE)--

Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for treating patients with Peripheral Artery Disease (PAD), announces the enrollment of the first U.S. patient in the CONNECT II global clinical trial. Dr. Ian Cawich of Arkansas Heart Hospital enrolled the first U.S. patient this morning. This announcement comes just two weeks after Dr. Bernhard Reimers enrolled the first European patient in the CONNECT II trial at Ospedale di Mirano in Mirano, Italy.

CONNECT II is a multi-center, non-randomized global clinical study designed to evaluate the safety and efficacy of Ocelot, the first-ever CTO crossing catheter to use real-time intravascular imaging technology called Optical Coherence Tomography, or OCT. Currently CE Marked, Ocelot is designed for crossing completely blocked arteries, or Chronic Total Occlusions (CTOs), in the legs while simultaneously using OCT to navigate inside the arteries.

We hope that physicians using Ocelot can now help prevent even more leg amputations in people suffering from PAD, said Avingers founder and CEO John B. Simpson, PhD, MD. The team here at Avinger has been working really hard and Im excited to see our efforts now go directly towards helping these patients.

The Ocelot catheter uses OCT technology as a navigation tool with the goal of traversing CTOs more safely and effectively as part of a procedure to restore blood flow back to normal in the legs. It allows physicians, in real time, to see whats happening inside the arteries during the actual intervention, giving patients a better chance to receive the best treatment possible during a single hospital visit.

We are participating in CONNECT II because our patient, if treated with other current options on the medical market, could face amputation and death, said Dr. Ian Cawich at the Arkansas Heart Hospital. With Avingers Ocelot, we believe this patient can be saved right now from both. The timing of this trial feels like a bit of miracle to our patient.

More about CONNECT II Clinical Trial

CONNECT II is a prospective, multi-center, non-randomized global clinical study that will evaluate 100 PAD patients with femoropopliteal CTO lesions at 17 sites, including three in the EU, where Ocelot received CE Mark in 2011.

As part of the trial, an independent group of physicians will review the angiography results to determine Ocelots crossing efficacy and safety.

Conditional FDA approval to conduct this study was received on January 27, 2012. Co-principal investigators for the trial include Arne Schwindt, MD of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon, MD, Austin Heart Hospital in Austin, TX.

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Avinger Enrolls First U.S. PAD Patient in CONNECT II Global Clinical Trial

Successful diet eases Mansfield boy's seizures and sparks fundraiser

Posted: March 7, 2012 at 6:05 am

Posted: Tuesday, March 6, 2012 4:09 pm | Updated: 9:45 pm, Tue Mar 6, 2012.

MANSFIELD A high-fat diet that would make a fitness guru cringe is proving to be a lifesaver for a township boy who has epilepsy.

An average meal for Korey Walton is a dollop of scrambled eggs, a strip of bacon, and two nickel-size slivers of a banana. Another typical meal is pork roll and cheese with no bun and four tiny Pepperidge Farm Goldfish crackers. A snack is a slab of butter with some peanut butter on the side.

Each meal must be washed down with 60 grams of heavy 6 percent cream, specially ordered from Wawa.

Since Korey, 8, began a ketogenic diet in January, his seizures have stopped and hes slowly becoming more energetic and engaged, his caretakers say.

You see his personality coming out. Hes talking, hes laughing and hes able to focus, said Lynn Schaefer, the nurse at Mansfield Township Elementary School.

Koreys mother, Dawn, said her son had tried numerous medicines to control his seizures since being diagnosed at age 4. The problem is that they stop working after about three months, she said. Korey seized from five to 50 times a day, the episodes lasting anywhere from 15 seconds to two minutes.

The family hit another roadblock in September, when Korey went to Childrens Hospital of Philadelphia for an operation to remove a part of his brain that causes the seizures. Doctors discovered more trouble spots and ruled out the surgery, Walton said.

Finally, Korey went back to CHOP in January for a week to try out the ketogenic diet, a plan comprised of 90 percent fat, 7 percent protein and 3 percent carbohydrates. The diet forces the body to burn fat rather than glucose, a state known as ketosis, and mimics what the body does when deprived of food. The diets use by epileptic patients is rooted in the 80-year-old discovery that seizures could be prevented by fasting, according to the Epilepsy Foundation of Landover, Md.

About 21 percent of patients remained seizure-free on a ketogenic diet, while about 62 percent of patients had the number of seizures reduced by half, according to CHOP studies. The hospital treats about 6,000 epilepsy patients each year, according to a CHOP representative.

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Successful diet eases Mansfield boy's seizures and sparks fundraiser

Diet Between the Districts: Teachers, school staff gain by losing

Posted: March 7, 2012 at 6:05 am

Tom Turnbull of Latrobe is thrilled to be a "big loser."

Turnbull, a sixth-grade teacher at Baggaley Elementary School in Unity, lost 53 pounds and 16.8 percent of his body weight in an eight-week weight loss challenge among 110 faculty and staff at the Greater Latrobe, Derry Area and Ligonier Valley school districts.

"This is so much fun. It is easier with the competition. It's been a battle for eight weeks," said Turnbull, who worked out twice a day for 10 days to drop pounds before the final weigh-in on Friday. He had been losing weight since the contest started in January -- timed perfectly for those who made New Year's resolutions to lose weight and eat healthier.

Although Turnbull's weight loss was impressive, he did not win the "Diet Between the Districts Weight Loss Competition." Those honors, based on the percentage of weight loss, went to Lou Keyser, a Greater Latrobe Junior High School teacher who dropped 25.1 percent of his body weight.

Celebrating at the Chick-Fil-A restaurant in Hempfield last week, the participants said the program motivated them to lose weight. Collectively, the 110 contestants lost more than 1,700 pounds, said Tim Evans, a Greater Latrobe School District health and physical education teacher who organized the competition.

"The main reason that we run the contest is due to the fact that as teachers, we need to be good role models. Our students look up to us," Evans said.

The competition provides an opportunity to open up a conversation between teachers and students about healthy eating and exercise, Evans said.

"If they see us eating healthy, exercising and maintaining a healthy body composition, then it will make them want to pick up these habits as well," said Evans, who came in second in the contest, dropping 24.9 percent of his weight. Evans, who shed 51 pounds during the challenge, said he would have won had he lost one more pound.

In order for the contestants to reach their goal, Evans, a personal fitness trainer for 11 years, promoted a dual approach of metabolic exercise and a diet that called for eating five small meals a day, no more than 300 calories a meal. Many of the contestants joined fitness clubs to get in shape.

One contestant, Kristine Lynch, a substitute personal assistant at Baggaley Elementary School, joined the competition because she wanted to loss weight "in a way to keep it off," she said.

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Diet Between the Districts: Teachers, school staff gain by losing

Research and Markets: Future Diet Trends and Opportunities: One Billion Adults Globally Are Overweight

Posted: March 7, 2012 at 6:05 am

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/7fb576/future_diet_trends) has announced the addition of the "Future Diet Trends and Opportunities" report to their offering.

In 2008, the World Health Organization estimated that there were approximately one billion adults globally who are overweight, and a further 475 million who are obese. This report offers a breakdown of the diet industry and explores the individual components which determine whether a diet plan is successful. The content places particular emphasis on the future of dieting.

Features and benefits:

Highlights

Changes in the global food system and more sedentary lifestyles have combined to create a global obesity crisis. Children around the world are getting fatter younger - a ticking time bomb in terms of poor health and rocketing medical costs. Dieting has to be part of the solution, with strong growth in this market almost assured.

Certain demographic groups are disproportionately affected by the obesity epidemic. Particular ethnic groups, and those on lower incomes, for example, are more likely to be overweight. Today's diet options remain 'one size fits all', but careful targeting and propositions designed to meet different dieters' needs represents a key opportunity.

With the launch of digital platforms, diet programs can now offer 24-hour support tools and engage dieters in more appealing and interactive ways. New diet programs have the opportunity to make quick inroads in the market while established brands need to take advantage of these new tools in order to maintain their market position.

Your key questions answered:

For more information visit http://www.researchandmarkets.com/research/7fb576/future_diet_trends

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Research and Markets: Future Diet Trends and Opportunities: One Billion Adults Globally Are Overweight

Body's 'Marijuana' May Be Key to Diet Pill

Posted: March 7, 2012 at 6:05 am

A dreamy diet pill that someday allows people to eat as much as they want without gaining weight seems possible, based on new research into certain brain chemicals that influence how quickly we burn fat.

Scientists used lab mice to turn down brain levels of endocannabinoids, chemicals produced by our bodies that are similar in molecular structure to the active ingredients in marijuana.

Previous research has found that endocannabinoids play an important role in regulating energy metabolism. In the new study, blocking the activity of endocannabinoids in the brain enabled mice to stay skinny without exercise or dieting. The researchers explained that the mice were in a "hypermetabolic state," in which their bodies were using up energy (that is, calories) at a much higher rate than normal.

"We discovered that these mice were resistant to obesity because they burned fat calories much more efficiently than normal mice do," study researcher Daniele Piomelli, a professor at the University of California, Irvine, said in a statement. "We had known that endocannabinoids play a critical role in cell energy regulation, but this is the first time we found a target where this occurs."

This target is a compound called 2-AG, found in high levels in mammalian brains, and researchers think it plays a role in the brain circuits controlling how the body uses energy, which we get from food.

A previous study by Piomelli found these compounds make us crave fat. To see if lowering the levels of these compounds had the opposite effect, Piomelli engineered the brain cells of mice to express only low levels of this compound, then compared the animals' behavior and health with that of normal mice.

The modified mice ate more and moved less than their normal counterparts, but stayed skinny even on a high-fat diet. Not only did they look healthy, they had normal blood pressure, and no increased risk of heart disease and diabetes that usually come with a high-fat diet.

The researchers determined that the modified mice's brown fat was overactive it was being turned into heat much quicker than in the normal mice. Brown fat is a type of fat that keeps mammals warm, and this heat creation burns off excess energy.

Jumping from lab studies in mice to actual health benefits for humans is still a ways away, though, since it is difficult to make a drug that acts only in one brain area.

"To produce the desired effects, we would need to create a drug that blocks 2-AG production in the brain, something we're not yet able to do," Piomelli said. "So don't cancel that gym membership just yet."

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Body's 'Marijuana' May Be Key to Diet Pill

Study: Most weight loss supplements are not effective

Posted: March 7, 2012 at 6:05 am

Public release date: 6-Mar-2012 [ | E-mail | Share ]

Contact: Melinda Manore Melinda.manore@oregonstate.edu 541-737-8701 Oregon State University

CORVALLIS, Ore. An Oregon State University researcher has reviewed the body of evidence around weight loss supplements and has bad news for those trying to find a magic pill to lose weight and keep it off it doesn't exist.

Melinda Manore reviewed the evidence surrounding hundreds of weight loss supplements, a $2.4 billion industry in the United States, and said no research evidence exists that any single product results in significant weight loss and many have detrimental health benefits.

The study is online in the International Journal of Sport Nutrition and Exercise Metabolism.

A few products, including green tea, fiber and low-fat dairy supplements, can have a modest weight loss benefit of 3-4 pounds (2 kilos), but it is important to know that most of these supplements were tested as part of a reduced calorie diet.

"For most people, unless you alter your diet and get daily exercise, no supplement is going to have a big impact," Manore said.

Manore looked at supplements that fell into four categories: products such as chitosan that block absorption of fat or carbohydrates, stimulants such as caffeine or ephedra that increase metabolism, products such as conjugated linoleic acid that claim to change the body composition by decreasing fat, and appetite suppressants such as soluble fibers.

She found that many products had no randomized clinical trials examining their effectiveness, and most of the research studies did not include exercise. Most of the products showed less than a two-pound weight loss benefit compared to the placebo groups.

"I don't know how you eliminate exercise from the equation," Manore said. "The data is very strong that exercise is crucial to not only losing weight and preserving muscle mass, but keeping the weight off."

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Study: Most weight loss supplements are not effective

Kirstie Alley Weight Loss Pictures: Before and After

Posted: March 7, 2012 at 6:05 am

Kristie Alley's 100-pound weight loss was helped by her 2011 Dancing with the Stars appearance. So how'd she do it? Well she's happy to reveal her secret since said secret also includes a plug for her personal line of healthy foods.

Kirstie Alley worked hard to lose more than 100 pounds. (Getty Images) The actress tweeted: "NO surgery, NO flippin lasers, NO barfing, NO starving...Jeez...my products, organic food, dance." Easy as pie...er, veggies!

While Kirstie is still no Skinny Minnie, she's done an admirable job of keeping the weight off after leaving the show, especially given her history of yo-yo dieting. She credits her success to her sustained dance regimen and has even encouraged others to take up dance in their quest for weight loss, launching a grassroots campaign called "100 Days of Dance" in January.

Check out more of Kirstie Alley's weight loss pictures from before and after below.

Actress Kirstie Alley speaks onstage during the 11th Annual Hollywood Awards held at the Beverly Hilton Hotel on October 22, 2007 in Los Angeles, California. (Getty Images)more pics Actress Kirstie Alley attends the premiere of "The Runaways" at Landmark Sunshine Cinema on March 17, 2010 in New York City. (Getty Images)more pics Actress Kirstie Alley poses during Mercedes-Benz Fashion Week Spring 2012 at Lincoln Center on September 13, 2011 in New York City. (Getty Images)more pics Kirstie Alley attends Maksim Chmerkovskiy's Ballroom Birthday Bash at the Hammerstein Ballroom on January 27, 2012 in New York City. (Getty Images)more pics

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Kirstie Alley Weight Loss Pictures: Before and After

Most weight loss supplements are not effective

Posted: March 7, 2012 at 6:05 am

ScienceDaily (Mar. 6, 2012) An Oregon State University researcher has reviewed the body of evidence around weight loss supplements and has bad news for those trying to find a magic pill to lose weight and keep it off -- it doesn't exist.

Melinda Manore reviewed the evidence surrounding hundreds of weight loss supplements, a $2.4 billion industry in the United States, and said no research evidence exists that any single product results in significant weight loss -- and many have detrimental health benefits.

The study is online in the International Journal of Sport Nutrition and Exercise Metabolism.

A few products, including green tea, fiber and low-fat dairy supplements, can have a modest weight loss benefit of 3-4 pounds (2 kilos), but it is important to know that most of these supplements were tested as part of a reduced calorie diet.

"For most people, unless you alter your diet and get daily exercise, no supplement is going to have a big impact," Manore said.

Manore looked at supplements that fell into four categories: products such as chitosan that block absorption of fat or carbohydrates, stimulants such as caffeine or ephedra that increase metabolism, products such as conjugated linoleic acid that claim to change the body composition by decreasing fat, and appetite suppressants such as soluble fibers.

She found that many products had no randomized clinical trials examining their effectiveness, and most of the research studies did not include exercise. Most of the products showed less than a two-pound weight loss benefit compared to the placebo groups.

"I don't know how you eliminate exercise from the equation," Manore said. "The data is very strong that exercise is crucial to not only losing weight and preserving muscle mass, but keeping the weight off."

Manore, professor of nutrition and exercise sciences at OSU, is on the Science Board for the President's Council on Fitness, Sports and Nutrition. Her research is focused on the interaction of nutrition and exercise on health and performance.

"What people want is to lose weight and maintain or increase lean tissue mass," Manore said. "There is no evidence that any one supplement does this. And some have side effects ranging from the unpleasant, such as bloating and gas, to very serious issues such as strokes and heart problems."

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Most weight loss supplements are not effective

Weight loss supplements don't work, says (another) researcher

Posted: March 7, 2012 at 6:05 am

CORVALLIS, Ore. An Oregon State University researcher says weight loss supplements don't work.

Melinda Manore, professor of nutrition and exercise sciences at the university, reviewed the evidence surrounding hundreds of weight loss supplements and found no credible evidence that any single product results in significant weight loss. Many have detrimental health benefits, she reported.

The weight loss supplement industry rakes in about $2.4 billion a year in the United States.

The study, "Dietary Supplements for Improving Body Composition and Reducing Body Weight: Where is the evidence?" is published online in the International Journal of Sport Nutrition and Exercise Metabolism.

She learned that a few products, including green tea, fiber and low-fat dairy supplements, can have a modest weight loss benefit of 3-4 pounds. But they were tested as part of reduced calorie diets.

For most people, unless you alter your diet and get daily exercise, no supplement is going to have a big impact, Manore said.

The supplements Manor examined fell into four categories:

Many products had no randomized clinical trials to hold up the claims. Many don't include exercise as part of the regimen.

No regimen for weight loss has replaced eating a balanced diet and regular exercise, she said.

Follow health reporter Harry Jackson Jr. on Twitter at http://www.twitter.com/STLhealthfor coverage of health, outdoors, health gadgets and tips from fitness trainers.

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Weight loss supplements don't work, says (another) researcher

Lawsuit Challenges Kardashian Sisters’ QuickTrim Claims

Posted: March 7, 2012 at 6:04 am

The Kardashian sisters are being sued over claims and endorsements they made about the QuickTrim weight-loss product line.

The class-action lawsuit was filed in the Southern District of New York, said The New York Daily News. Four plaintiffs allege that reality sisters Kim, Kourtney, and Khloe made unsubstantiated, false and misleading claims in advertisements, interviews, and tweets, touting QuickTrims efficacy.

A recent U.S. Food and Drug Administration (FDA) evaluation revealed that the key ingredient in QuickTrim is caffeine.

Attorneys for the plaintiffs, who are based in New York, California, and Florida, criticized the ubiquitous sisters and QuickTrims manufacturer, Windmill Health Products, for perpetuating false claims that QuickTrims line curbs cravings, promotes weight loss, and burns calories. The sisters have been identified with the brand since 2009 and are known to mention QuickTrim products during television and magazine interviews, telling their fans that they use QuickTrim products to lose weight and maintain that weight loss, said The Daily News.

In January 2010, Kim Kardashian told Ok! magazine that she used a number of QuickTrim products to quickly drop 15 pounds in a few short weeks, said USNews. Both Khloe and Kim have boasted 15-pound weight losses with QuickTrim, said ABC News.

The $5 million class-action lawsuit, filed Thursday in federal court in New York, alleges that no competent and reliable scientific evidence supporting any of these claims exists, said US News. As a matter-of-fact, The FDA has in fact determined that there are inadequate data to establish the general recognition of the safety and effectiveness of caffeine for the specified use of weight control, the lawsuit states.

The lawsuit also blasts the products advertising, which encourages consumers to utilize the full range of QuickTrims product line, which includes pills and so-called cleanses for increased efficacy, but with no evidence supporting these conclusions, said The Daily News. The line also includes powdered drink mixes and was created to detoxify and clean the body by removing extra water weight and bloating, due mostly to the laxatives in the products, according to the manufacturer, said USNews.

QuickTrim products are widely available nationwide at more than 25,000 retail chains, including Wal-Mart, Walgreens, CVS, and GNC. Quick-Trim ins based in New Jersey said ABC News. Not only is there no scientific evidence to back up QuickTrims claims, recent research suggests cleansing products such as what QuickTrim touts are ineffective and dangerous, said US News. A study published last year in the Journal of Family Practice reviewed 20 case studies reported over 10 years and found that colon cleanses can lead to a number of issues from mild cramping to kidney failure, said USNews. These products tout benefits that dont exist, the study authors said.

This is not the first time the Kardashians have been involved in litigation over their marketing endorsements, said The Vancouver Sun. Endorsement deals accounted for a huge chunk of the Kardashians net worth at a whopping $65 million in 2010, according to industry trade magazine The Hollywood Reporter. Kim, 31, is one of the highest paid U.S. reality stars with 2010 earnings estimated at about $6 million for her reality show; clothing line; and many fitness, beauty, and other endorsements.

Last year, the sisters and their mother, Kris Jenner, were involved in a $75 million debit card endorsement lawsuit involving the Kardashian Kard, over allegations that the card charged prohibitive consumer fees, said The Vancouver Sun.

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Lawsuit Challenges Kardashian Sisters’ QuickTrim Claims


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