Apollo Endosurgery Announces CE Mark Approval for the ORBERA365™ Managed Weight Loss System, Expanding the Indwell Period from 6 Months to 12 Months with the Gastric Balloon Category Leader

AUSTIN, Texas–(BUSINESS WIRE)–Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced CE (Conformité Européene) Mark approval for the ORBERA365 Managed Weight Loss System.

The ORBERA365 Managed Weight Loss System doubles the indwell period of the #1 intragastric balloon in the world from 6 months to a 12 month treatment period. The approval enables Apollo to market and sell the ORBERA365 Weight Loss Balloon in European Union and the European Economic Area member countries. The Company expects ORBERA365 to be commercially available starting in the fourth quarter of 2017.

“I’ve been using ORBERA since 1999 and have helped thousands of patients lose weight with my ORBERA program. Now with ORBERA365 patients will have the possibility of getting better weight loss results because in my experience the longer the treatment the more weight patients tend to lose. Actually, using ORBERA365 our patients will now have twice as long to change their eating behaviors and ensure long lasting results,” said Professor Alfredo Genco, Sapienza University, Rome, Italy.

“The CE Mark approval of ORBERA365 has been a significant accomplishment for Apollo and involved a comprehensive review of clinical and non-clinical data by a regulatory body in a market with deep understanding and experience with intragastric balloon therapy. Obtaining CE Mark approval now for ORBERA365 is a strong testimony of the relevance and significance of more than a decade of the ORBERA system’s safety and efficacy data as supported by more than 277,000 distributed implants and 230 published peer-reviewed papers,” said Todd Newton, CEO of Apollo Endosurgery.

About ORBERA365™

ORBERA365 is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.

In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA365 balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 minutes and the patient can generally go home a few hours later. After up to twelve months, through another non-surgical procedure, the ORBERA365 balloon is deflated and then removed.

Once the balloon is in place, the patient works with their physician and their staff in a formal lifestyle modification program to meet their long-term weight loss goals. Coaching takes place over 12 months while the balloon is in place. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.

For additional information regarding ORBERA365, please visit www.orbera.com/uk-ireland/.

For full safety information please visit www.orbera.com/uk-ireland/dfu.

For more information regarding weight loss surgery or non-surgical weight loss options in Los Angeles, please visit www.lapbandla.com.

Adjustable Gastric Banding From Another Perspective

Adjustable Gastric Banding (AGB) is a misunderstood weight loss surgical procedure that has helped thousands of patients suffering from obesity for 24 years. Most bariatric surgical procedures such as the lap-band, require multiple interventions (beginning with least invasive to more invasive) during a patient’s life, just like other chronic diseases. While the article in JAMA suggests that subsequent surgical interventions post AGB are costly, a group of concerned bariatric surgeons disagree.

The JAMA article reported that among 18.5% of patients underwent about 4 (and some as many as 12) additional interventions post Adjustable Gastric Banding. AGB patients usually undergo either one or two additional operation, therefore the bariatric surgeons wonder about the reasons behind the questionable data. It could be one or more of the following reasons: (1) assignment of inaccurate International Classification of Diseases, Ninth Revision codes during subsequent hospitalizations for patients who were initially coded as an AGB patient; (2) inclusion of procedures to address post-stapling complications in patients who had their bands removed and were subsequently converted to a stapling procedure; (3) performance of multiple operative interventions on AGB patients by surgeons who have no familiarity with the gastric band and its aftercare; and (4) inadvertent billing for up to 12 surgical procedures when indeed such procedures were never performed.

Bariatric surgeons admit that subsequent procedures on AGB patients are costly. However, since AGB is one of the safest and most effective bariatric interventions, it should be reimbursed by Medicare and other insurance plans. It is regretful that the public has been misrepresented with inaccurate data and misguided by the deceptive article reported by JAMA. However, the bariatric surgeons are thankful for the chance to provide their second opinion in General Surgery News.

The most popular Adjustable Gastric Banding procedure in the world is the lap-band procedure. It is one of few procedures that had been proven to be very effective and safe as a weight loss surgery. Choosing the right obesity treatment is a serious task and should not be taken lightly. If you happen to be a Los Angeles or Southern California resident who needs to speak with a weight loss physician regarding their weight loss problem and obesity treatment options, please visit LapBandLA.com.

References: A Second Opinion on Gastric Banding retrieved from http://www.generalsurgerynews.com/Opinions-and-Letters/Article/07-17/A-Second-Opinion-on-Gastric-Banding/41843/ses=ogst?enl=true

Now I have no more diabetes, and sleep apnea.

I am so grateful to Dr David Davtyan, that I wake up every morning, and ask God to bless him! I had the surgery five months ago, it was very smooth. Dr. Davtyan’s team was very nice and they made me feel very comfortable. Now I have no more diabetes, and sleep apnea. I passed my treadmill test yesterday without passing out! I feel so much younger and happier now that I lost 30 lbs! I enjoy visiting Dr. Davtyan’s office; they are like a family to me! There is no out of pocket cost from me, as it was covered by Medicare.


I would refer anyone who wants to get lap band done to Dr. David Davtyan

I was referred to Dr. David Davtyan by my friends and family. We trust him completely. My lap band surgery was simple; I was back on my feet in 1 week. Dr. Davtyan staff is knowledgeable. I feel very comfortable talking to Dr. Davtyan. I was 50lbs overweight 2 years ago. Now I can get around much more easily, I have a better esteem. I did not use to like socializing; now I want to go out more. Lap band is the safest weight loss surgery. I am a self paid patient. I would refer anyone who wants to get lap band done to Dr. David Davtyan, no question asks, absolutely!


Long Term Weight Loss-Contrave, a New Drug, after Laparoscopic Surgery

Long term weight loss is a desired goal for obese individuals. Individuals with a BMI (Body Mass Index) score of over 40 are considered morbidly obese. Obesity causes diseases such as diabetes, cancer, hypertension, high cholesterol, coronary artery disease, sleep apnea, liver and pulmonary disease, and others. It can also lead to anxiety, depression, substance abuse, chronic pain, insomnia, social isolation and sexual dysfunction.

Morbid obesity for example, can be effectively treated with laparoscopic surgery such as the lap band. Then the weight loss can be maintained with the help of medications such as the upcoming Contrave (developed by Orexigen Therapuetics, Inc). Contrave contains two appetite suppressants: naltrexone HCL and bupropion HCL.

When an individual is going through initial weight loss, the brain is conditioned to trigger hunger in the body and to slow down the metabolism. These hunger signals are counter-productive to weight loss, and excess weight could return as one relents to the demands of the brain. In order to maintain long term weight loss, one option is to use Contrave. Its active ingredient bupropion HCL initiates the weight loss, and its naltrexone maintains the weight loss. Bupropion is a widely-prescribed antidepressant and smoking cessation medication; naltrexone is a treatment for alcohol addiction. The two ingredients work to inhibit the neural circuits in the brain that cause hunger.

Dr. David Davtyan, an expert in laparoscopic surgery, has extensive experience helping patients achieve long term weight loss.

Call 1-877-9BESLIM (923-7546) for more information today!

More resources about Contrave:

Rupert Shepherd B.Sc. Promising New Obesity Drug Contrave® Looks Set For FDA Approval.”

Medical News Today. MediLexicon, Intl., 22 Sep. 2011. Web.

24 Oct. 2011.

Obesity Linked to Atrial Fibrillation

Dr Hany Abed doing research at the University of Adelaide has shown that obesity directly causes electrical abnormalities in the heart.

Evidence shows that obesity can increase blood pressure, change the structure and size of the heart muscle, the way the heart works, contracts, and its electrical function.

Electrical dysfunction of the heart leads to atrial fibrillation which affects 10% of people over 75 years old.

Atrial fibrillation commonly leads to heart attacks and strokes.

As the population gets fatter, it is  predicted that by 2020,  over 67% of atrial fibrillation cases will be due to obesity. Overweight men are most at risk for developing atrial fibrillation.

He is studying  how obesity affects the heart and if weight loss can reduce the risk of developing atrial fibrillation.

Early results show weight loss can reverse atrial fibrillation.

Overweight Young Adults Risk Early Death

A study published in Aug 2011  in the Journal of Adolescent Health found that being overweight at 25 years old increased the risk of early death by 21%. That risk went up to 28% if a young adult  with a higher BMI (body mass index) also smoked, drank alcohol, or did little exercise.

The risk of early death was  higher in obese men compared to women, and African-American women compared to white women.

They found  that in all ethnic groups, except in African- American men, the shortened lifespan risk due to being overweight in young adulthood  is not cancelled out by later weight loss in middle age.

They conclude that a healthy lifestyle must be established and maintained from an early age.

Developing Diabetes Strongly Associated with a Fatty Liver

A new study published in the Journal of Clinical Endocrinology & Metabolism showed that a patient diagnosed with fatty liver found on an ultrasound exam strongly predicts the  likelihood of  developing  diabetes type 2 in 5 years .

Over 11,000 patients were followed for 5 years . They compared patients with high insulin resistance with and without a fatty liver.  Those who had a fatty liver were also found to have  other risk factors like  high triglyceride and  glucose levels,  lower HDL cholesterol, excess weight, and hypertension.

They found that even in otherwise healthy individuals, those with a fatty liver found on ultrasound is an independent risk factor  for  developing  diabetes type 2 in 5 years.

Less Colon Polyps with Moderate Exercise

A study published in the British Journal of Cancer found that physical activity can reduce the risk of developing polyps by 16%, and developing large or advance polyps by 30%, and the  risk of colon cancer by 25%.  An analysis of studies involving over 250,000 patients, found less precancerous colon polyps in those individuals who exercised moderately  30 minutes a day.  This benefit was found in both men and women.  Proposed explanations  for this effect is that exercise can boost the immune system and reduces inflammation in the bowel.

Weight Reduction May Improve Outcomes with Cirrhotic Liver


Findings  published in the August 2011 issue of Hepatology, revealed that obesity may be a frequent cause of chronic liver disease progression. Liver cirrhosis, according to one study, in over 15% of cases,  is caused by being overweight. Other studies showed that those suffering from liver disease due to obesity had a lower survival rate than those with viral liver disease.

A study,  that followed patients with liver cirrhosis for almost 6 years, found that overweight  or obese  patients have about a  30-40% increased  risk  of their chronic  liver disease progressing to ascites (increased fluid in the abdomen), variceal hemorrhage( bleeding from abnormal vessels), or hepatic encephalopathy( worsening brain function due to the livers inability to remove toxins from the blood).

According to the World Health Organization, 1.5 billion people are overweight or obese. Further studies are needed to find if weight loss may improve outcomes in chronic liver disease.

How Much Exercise Is Enough?

According to data from the Behavioral Risk Factor Surveillance System in 2005, less than 50 percent of the United States population participates in “recommended” levels of physical activity. You may be wondering what exactly the “recommended” levels of physical activity are. The recommended levels of physical activity (including both the amount and intensity) differ per person’s individual needs and their exercise goals. In other words, is the goal weight loss or maintenance, increasing one’s energy levels, controlling blood pressure, or blood sugar, etc.?  Activity is not a one-size-fits-all prescription.

            There is a common misconception that if you are thin then you are fit. That is false. Regular activity is what defines fitness, not thinness. The benefits of exercise can only be achieved by engaging in REGULAR activity on a consistent basis. Current exercise recommendations from the United States Department of Health And Human Services for adults aged 18 and older are 150 minutes of moderate-intensity cardiovascular activity (brisk walking) per week, or 75 minutes of vigorous activity (jogging) per week plus 2 or more nonconsecutive days of muscle strengthening activity. A person can achieve the same benefits from exercising 30 minutes a day, regardless of how they incorporate that 30-minute exercise routine into their schedule. For example, a study by Jakicic et al. showed that splitting long exercise bouts into small bouts of at least 10 minutes over the day, improved patient adherence to regular activity and was just as effective in achieving weight loss, compared to a patient who engaged in a long exercise bout at one time.

            The National Weight Control Registry has routinely showed that over 60 minutes of activity per day is critical for long-term weight loss success and maintenance. It is believed by many that variety is the key for not only improving strength and fitness from working different muscles in multiple ways, but also for keeping patients engaged and motivated.

            There are currently limited studies looking at the impact of activity in post-bariatric surgery patients. A study done by Bond et al. discovered that patients, who were inactive pre-operatively but became active post-operatively, not only lost an additional 13 pounds, but also had greater improvements in quality-of-life scores in relation to mental health, general health, and vitality. Regardless of the limited research for post-bariatric surgery patients, it is still recommended that for long term health, fitness, and weight management benefits, these patients need to be active.

            In conclusion, every person, whether obese or thin, healthy or unhealthy, needs to engage in regular activity on a daily basis, since there are many long-term risks from inactivity.

Peraino, A.M., M.D. Physical Activity for Health and Weight Loss: How Much is Enough? Bariatric Times. 2011; 8(2):13-15

Gastric Banding Pays for Itself…

A new study published in the journal Surgery for Obesity and Related Diseases concluded that the cost of Gastric Banding weight loss surgery was cost effective in roughly two years post-op by reductions in obesity-related medical costs in those with a history of Diabetes and in roughly four years post-op in those patients without Diabetes. Currently, obesity costs the U.S. roughly $70 billion a year. The nation’s total medical bill as a result of obesity is currently estimated at $147 billion a year and represents about 10% of all medical expenses in the U.S. That 10% is estimated to increase to 16-18% of all U.S. healthcare costs in the next 20 years.

Whey Protein May Affect Weight

A study published in The Journal of Nutrition June 2011 showed that whey protein may be helpful in weight loss.

They assigned 90 overweight and obese men and women with an average weight for men of 218 pounds and 190 pounds for the women to 1 of 3 groups. All the groups had an average daily caloric intake of 2,200 calories per day.

The first group added whey protein drinks to their normal diets, the second soy protein, and the third group added carbohydrate drinks. All the drinks had 52 grams per packet of protein or carbohydrates and all the drinks totaled 200 calories each. They were to be drunk at breakfast and dinner. None of the participants knew which type of shake they were drinking. Participants were also to keep a food diary.

After 6 months, they observed that those who drank the carbohydrate shakes gained 2 pounds, the weight of those who drank the soy shakes remained about the same, and those who drank the whey protein shakes lost 2 pounds but also lost about 1 inch around their waistlines.

The soy protein group was found to have higher levels of thyroid hormones, which may have accounted for the maintenance of their weight despite the added calories. Thyroid hormones are known to increase metabolism.

The whey protein group had significantly lower levels of the hormone that regulates food intake, ghrelin. Higher blood concentration of ghrelin correlates with increased hunger. An inexplicable finding was those on whey protein shakes ate less carbohydrates by the end of the study though their total caloric intake did not change.

Be advised to read labels as whey products are high in fat and calories.

Migraines May Lead to Stroke

Migraine could be a risk factor for stroke. The probability of stroke increases if the patient also has hypertension.  Those 40-49 years old who suffered from migraines and hypertension had a 5% more chance of getting a stroke than those with hypertension alone. This study was done in Italy and included almost 3,000 subjects. The findings were presented in 2011 at the   European Meeting on Hypertension 2011 by Dr. Enrico Agabiti-Rosei.  He concluded that further studies need to be done on whether early migraine treatment can reduce the risk of stroke.

PCOS and Infertility Resolved After Weight-Loss Surgery

A study analyzed medical records of women who underwent Roux-en-Y gastric bypass surgery between 2000 and 2009. Of the 566 women, 31 (5.5%) had Polycystic Ovarian Syndrome (PCOS) prior to their surgery. The women had a mean age of 32 and had suffered from PCOS for roughly 8 years.

Improvement in PCOS symptoms (including infertility, hirsutism, and menstrual dysfunction) roughly occurred during the first year after surgery. Furthermore, improvement or resolution in symptoms increased over time with excess weight loss.

Every woman suffering from infertility prior to surgery, who wanted to conceive, was able to conceive either naturally or by assisted reproduction within 3 years of their surgery.

Ironically, in 2009, the American College of Obstetricians and Gynecologists published new guidelines for the recommendations and treatment of infertility and Bariatric surgery is not listed as one of the components of treatment despite this study’s positive findings of weight loss surgery helping conception.

Protein for Breakfast Decreases Hunger Later

Three groups of teenagers were studied at the University of Missouri for 3 weeks. They either skipped breakfast, 60% actually do skip, ate a normal amount of protein, a 500-calorie meal consisting of cereal and milk, or a high-protein breakfast.

At the end of each week they filled out a form rating appetite and satiety and their brains were scanned with functional magnetic resonance imaging (fMRI) to measure the activity in the areas that control food motivation and reward-driven eating behavior.

The fMRI results showed those that ate protein for breakfast had decreased brain activity in those areas that controlled food motivation and reward before lunch. Those subjects that ate a high protein breakfast reported an even greater satiety and less appetite.

 Skipping breakfast has been strongly associated with snacking high in sugar, fat and calories, overeating (especially at night), weight gain and obesity. Eating a healthy protein-rich breakfast can keep people satisfied longer, control appetite, be less prone to snacking, and prevent overeating.

Decreased Migraines with Bariatric Surgery

A small observational study out of Rhode Island showed that weight loss was associated with less frequency and intensity of migraine headaches in obese subjects.

24 severely obese women, who suffered from migraines, were assessed before and 6 months after undergoing bariatric surgery. Their mean body mass index (BMI) before and 6 months after surgery was 46.6 and 34.6, respectively.

Nearly half (46%) of the subjects experienced at least a 50% reduction in their headache frequency, this was despite the fact that nearly 70% of these subjects were still considered obese. This finding was also regardless of the type of weight loss surgery the patient had; 58% of the patients had the LapBand.

Weight loss has yet to be proven to improve migraines, but they think it definitively has an effect.

Their findings were published March 29 in Neurology.

Low Testosterone in Men Reversed with Bariatric Surgery

 Low testosterone and sexual dysfunction is common in morbidly obese males. A new study out of the University of Louvain in Brussels showed that these problems may be reversed with weight loss after bariatric surgery.

 They found low testosterone in 27 out of 75 obese men in an obesity clinic. Signs of androgen, or male hormone, deficiency included low libido and erectile dysfunction were reported in 72% of subjects. They also measured body fat and body mass index (BMI) and found the higher the BMI and body fat the lower the testosterone levels.

 Between 2007 and 2010, 17 men underwent bariatric surgery and were assessed 12 months later. They had lost an average of 90.2 pounds. They had no complaints of sexual dysfunction after their weight loss surgery and their testosterone levels had increased to the normal range.

 Article URL: http://www.medicalnewstoday.com/releases/227519.php

Lose Weight with More Sleep and Less Stress

A research team at Kaiser Permanente found that good predictors of weight loss were the amount of sleep one got per night and stress levels experienced. They published their findings in March 2011 in the International Journal of Obesity.

Sleep, stress, television viewing, and computer screen time are factors that have been studied and associated with obesity but few have studied whether these factors correlated with weight loss.
About 500 subjects were asked to lose at least 10 pounds over six months and to report levels of insomnia, stress and depression, and to record how much time they slept and spent watching television or using a computer.

Each participant was weighed weekly, advised to keep a daily food diary, reduce caloric intake by 500 calories per day, eat a low-fat, low-sugar diet with lots of fruits and vegetables, and exercise at least 30 minutes, 6 times a week.
They found that those most likely to lose 10 pounds were those with the lowest stress levels and who got more than 6 hours, but less than 8 hours, of sleep per night. Also noted was that these subjects were twice as successful in losing weight as those who reported the highest stress levels and got less than 6 hours of sleep per night.

The research team found that sleep and stress levels were good predictors of weight loss, but depression and screen time were not.
This study suggests that if you want to increase your chances of losing weight reduce your stress level and get adequate sleep.