Digestible Balloon Therapy

Posts by Fred Voss

FDA Obesity Device Approvals  0

Regulatory Breakthrough

July 29 2015. WASHINGTON (Associated Press) — Federal health regulators on Tuesday approved an inflatable medical balloon that aids weight loss by filling up space in the stomach. The Food and Drug Administration cleared Reshape Medical’s Duo balloon as another option for millions of obese Americans who have been unable to lose weight via more traditional methods…. FDA Approves ReShape Medical Balloon for Weight Loss

August 6 2015. Apollo Endosurgery’s gastric balloon, Orbera, was approved by the FDA to assist obese adults with a body mass index of 30 to 40 to lose and maintain weight….  FDA Approves Apollo Endosurgery Weight Loss Balloon

The approvals of these two gastric balloons, that have been sold in Europe for 20 years and 7 years (Orbera and Reshape respectively), indicate that space filling bariatric treatment methods can meet US standards as safe and effective devices.

These FDA approvals validate the gastric filling treatment as advanced by PlenSat digestible balloons.

The company believes that successful completion of clinical studies and other regulatory activities will ultimately enable PlenSat digestible balloons to serve patients in the United States – the single largest market in the world.

Quality of life and weight loss for obese individuals  0

A  blog entry on Dr. Sharma’s excellent Obesity Notes discusses findings reported at the 2014 Obesity Society meetings. The information was presented at a poster presentation by Lindsey Warkentin, MSc, Lead Research Assistant – Acute Care and Emergency Surgery Service at University of Alberta, Edmonton, Canada, and her colleagues

The analysis suggests that to achieve meaningful quality of life improvements obese individuals with BMI > 45 must lose weight to an extent that is only achievable with bariatric surgery. Her conclusion:

“Given that surgery is not a realistic option for the millions of people living with severe obesity, we simply need to find better medical treatments that can deliver sustainable weight loss of this magnitude”


Obesity as a disease  0

The following is a post I made on the LinkedIn Medical Devices forum in response to an issue raised regarding the recent decision of the AMA to classify Obesity as a disease.

An active discussion continued and is still drawing comments, many off topic for the medical device forum.

An excellent discussion and represents a broad slice of current attitudes towards weight. Simply stated we as a society have bias against overweight and obese individuals for the most part and see this as personal failure on their part. Into this mix we throw condemnation of the food industry, government programs and a host of other issues.

This discussion and many like it are going on around the world as we face a real crisis in health care from both the perspective of people’s lives and the cost to the healthcare budgets of many countries around the globe.

As someone who has been working on a device to treat obesity I have certainly changed my attitudes towards the issue over the years. I post the following for the discussion group and welcome comments.

A video of our efforts can be found at

The problem of the rise in obesity can be traced to the mid 70’s as shown in the ‘Rising Rates of Obesity’ as shown on another blog page.  It is interesting that a timeline for the increase in sales for fast food companies essentially parallels this graph; cause and effect? A similar correlation can be found in the rise in computer gaming, remember Pong? The game was originally manufactured by Atari Incorporated (Atari), who released it in 1972. ( In addition to this is the change in behavior patterns for children. How many parents allow their children to walk to elementary school? I know that in the mid 50’s I walked roughly two miles each way to school from first grade to sixth grade. AND YES it was uphill both ways in the driving sleet and snow (even in Los Angeles – ). Seriously every elementary school these days has a line of parent’s cars waiting to pick up their children. Kids are not allowed to wander over to the local park, as we did, to run, roughhouse and generally be kids. Why, again multifactorial but largely a fear of child abductions in my honest opinion.

Where does that get us in this discussion, the causes of obesity and the increase in over the last 40 years has many causes and it is not simply that we as a nation or a species has become lazy. Add this to the fact that once you have gained weight the body fights you every time you try to lose weight as has recently been shown by researchers. An excellent analogy to this was posted today (7/3/13) by Dr. Aryl Sharma, a Canadian expert on Obesity and treatment. (

An additional issue is the relationship between obesity and comorbities. The BMI index is clearly only a rough indicator of the effects of weight on health. However, statistics support a weight base first pass at understanding these issues. Dr. Sharma has developed a staging system, the Edmonton Obesity Staging System ( that is being used more frequently to determine treatment.

What we do know is that obesity itself, i.e. >30 BMI does not predict metabolic disease. The breakdown for metabolic disease and road to type II diabetes is related to weight in the following manner, two-thirds of obese, BMI > 30 have metabolic disease, one-half of overweight, BMI > 25 and < 30 have metabolic disease, and one-third of BMI < 25, normal to underweight have metabolic disease. These numbers are for men and the data is slightly different for women. This is related to a combination of genetic, diet (high carbohydrate consumption) and other factors. I posted a link to a graph showing this information on my LinkedIn page.

The classification of obesity as a disease reflects an honest attempt to encourage better understanding of the issue and promote better discussions between patients and physicians. Of course we can always point to alternative rationale, many of them at least partly true. The real issue is how do we deal with an incredible problem and see that patients are afforded appropriate care and the costs in terms of patients’ lives and healthcare dollars are better managed.



PlenSat is a pre-clinical stage medical device company developing a new approach to obesity control. The Company has conceived of a new device, The Digestible Balloon, which the Company believes will provide the benefits of bariatric surgery (stomach stapling, stomach banding, gastric bypass, and gastric balloon insertion) without medical intervention. This new device will potentially provide ease of use and reversibility to the increasingly popular invasive approaches, including endoscopic procedures. These invasive procedures have demonstrated the ability to control excessive food consumption leading to life style changes and sustainable weight reduction in numerous.




The use of the Digestible Balloon will allow a pharmaceutical ‘pill’ approach to delivery of a stomach space filling device for hunger control. There are literally 10’s of millions of overweight and obese individuals that can be classified as pre-diabetic or otherwise suffering from their condition with physical issues. The numbers of individuals overwhelms the ability of the healthcare community to provide bariatric therapy, in the form of bypass surgery, laparoscopic banding or endoscopic intragastric balloon insertion and removal. A self inflating device that is eliminated over time by natural digestive action is a simple approach to this problem for many individuals.




A full generic map for the causes and influences that have led to the obesity epidemic is shown below. It is certainly complex and not simply eating too much and doing too little.


Obesity system


Obesity is caused by a combination of genetics, environmental issues, and behavioral factors.1,2,3 Consumption of high-calorie foods, consumption of too much food, and a sedentary lifestyle all work together to create this condition. Obesity is associated with the development of diabetes mellitus, hypertension, dyslipidemia, arthritis, sleep apnea, cholelithiasis, cardiovascular disease, and cancer. More than 100 million Americans (65% of the adult population) are overweight. Obesity is the second-leading cause of preventable death in the United States after smoking. Obesity-related diseases account for 400,000 premature deaths each year. Obesity can be treated medically and surgically. Medical treatment for obesity is difficult, because the amount of weight lost is small and patients tend to regain most of the weight.1 A 2010 prospective, randomized controlled trial in 50 adolescents demonstrated that a greater percentage of patients achieved a loss of 50% of excess weight with laparoscopic gastric banding than with lifestyle intervention.4 Operations that are designed to cause significant and long-lasting weight loss in patients who are severely obese are termed bariatric surgery. The term bariatric surgery is derived from the Greek words baros (weight) and iatreia (medical treatment). Laparoscopic lap band placement, described here, is one such surgery. For information on gastric bypass (another form of bariatric surgery), see eMedicine article Laparoscopic Gastric Bypass. Body mass index (BMI) describes relative weight for height and correlates significantly with an individual’s total body fat.3 BMI is based on height and weight and applies to adults of both sexes. BMI is calculated as follows: BMI equals weight in kg/height in m2 or weight in lb/height in square inches.5,2


1. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Morbid Obesity. SAGES Web site. Available at Accessed November 10, 2008.

2. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Morbid-Obesity.Info. SAGES Web site. Available at Accessed November 10, 2008.

3. National Institutes of Health. U.S. Department of Health and Human Services. Clinical Guidelines on the Identification, Evaluation and Treatment of Overweight and Obesity in Adults. Obesity Education Initiative

4. [Best Evidence] O’Brien PE, Sawyer SM, Laurie C, Brown WA, Skinner S, Veit F, et al. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. JAMA. Feb 10 2010;303(6):519-26

5. National Institutes of Health. Gastrointestinal surgery for severe obesity. NIH Consensus Development Conference. March 25-27, 1991;9(1) (