The prospective, randomized study was conducted by three principal investigators: Brian Quebbemann, MD, FACS, Center for Advanced Laparoscopic Surgery, Newport Beach, California; Jaime Ponce, MD, FACS, FASMBS, Hamilton Medical Center, Dalton, Georgia; and Emma Patterson, MD, FRCS, FACS, Legacy Good Samaritan Medical Center, Portland, Oregon.

The results of the study are being presented today at the American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting during the Emerging Technologies Session by Dr. Jaime Ponce. “The study results are very encouraging. Although more extensive clinical study remains necessary, this initial feasibility data suggest that the ReShape Duo could be an attractive option for patients not ready to make a decision for surgery or a permanent implant,” said Dr. Ponce.

Dr. Brian Quebbemann, the first physician in the U.S. to treat patients with the ReShape Duo, added, “ReShape Duo may have an important role in the treatment of obesity as both a six-month jump-start to weight management as well as providing a key component of longer-term therapy.”

“We are pleased with our recent U.S. data and look forward to continued investigation in a U.S. pivotal study,” said Ken Charhut, ReShape Medical CEO. “There is a wide gap between conventional behavior modification and invasive surgery. The ReShape Duo bridges this gap with a reversible, non-surgical approach to weight loss.”

About the ReShape Duo™
ReShape Duo is a non-surgical, dual-balloon treatment designed for the millions of people who want weight loss support, without the invasiveness of surgery or side effects of drugs. The device occupies existing space in the stomach to reduce its capacity for food. The dual-balloon is designed to maximize space occupation in the stomach and conform to the stomach’s natural anatomy for efficacy and stability. ReShape Duo is placed in the stomach during a 30-minute outpatient procedure using deep conscious sedation. The dual-balloon remains in the stomach for up to six months and is then removed.

About ReShape Medical®, Inc.
ReShape Medical is a development-stage medical device manufacturer headquartered in Southern California. The company is focused on the development of a non-surgical weight loss device that can be used as an aid in the treatment of obese or overweight patients.

CAUTION–Investigational device. Limited by United States law to investigational use.
For more information, please visit www.reshapemedical.com.

The next frontier for researchers is finding a less invasive option that could help people who are just below or above the eligibility guidelines for the two most popular forms of bariatric surgery — gastric bypass and laparoscopic gastric band placement — as well as those considered too young for such procedures.

A doctor at UC Irvine hopes he has found that next-generation solution: a double-balloon mechanism that is inserted down the patient’s throat with a tube attached. It’s then inflated with saline. Resembling a water balloon that’s twisted into two oval sections, it rests inside the stomach and gives the patient a feeling of being full. The device, marketed by an Orange County-based company, is scheduled to undergo its first U.S. clinical trial starting this spring among 30 patients at three medical centers, including UCI.

Dr. Ninh T. Nguyen, a gastrointestinal surgeon at UCI’s bariatric surgery services program, said if the device proves safe and effective during this phase, the research will be expanded to 350 patients at 10 medical centers around the country. If the balloon eventually is approved by the Food and Drug Administration, it would become the first weight-loss surgery option available on an outpatient basis, with patients able to go home the same day.

It also could be prescribed for patients as young as 13 who are severely obese. According to a study by Centers for Disease Control and Prevention released last month, 18.1 percent of U.S. children age 12-19 are considered obese.
“We’re excited about this, because of the adolescent and childhood obesity epidemic,” Nguyen said.

Two questions arise: 1) Why not just put these patients on a program of diet and exercise? 2) Isn’t a bariatric procedure the easy way out? These remedies are meant as last resorts for those who have “co-morbidities,” meaning other problems that stem from obesity, like diabetes, coronary disease or severe joint problems that often make exercise difficult. Nguyen added that dieting only gets these patients so far.

In gastric bypass, the stomach is sectioned off and the small intestines rerouted to a smaller stomach “pouch.” The “lap band” accomplishes the same goal with a silicone band. Gastric bypass is viewed as more effective at helping patients keeping off excess weight, but it’s more invasive, with a longer recovery time. Unlike bypass, the lap band is reversible.
Nguyen and others at UCI published research recently showing that outcomes for both kinds of procedures have improved since the Centers for Medicare and Medicaid Services issued a directive in 2006 stating that the federal government would no longer pay for such procedures unless they were performed at centers that had the experience, staff and equipment to handle a large number of cases. Since then, the average hospital stay for bariatric surgery has decreased from 3.5 days to 3.1 days; the complication rate has gone from 12.2 percent of patients to 10 percent; and most importantly, the 30-day mortality rate has shrunk from 0.28 percent to 0.20 percent.

That rate stood at around 2 percent as late as 2001, five years before the government’s directive had the effect of pruning the number of providers from 60 to 45, including UCI. Now such procedures are roughly as safe as gall-bladder surgery, Nguyen said. “This is not the old days anymore.”

A person is considered overweight if he or she has a body-mass index of 25 or above. For someone 5-foot-9, that works out to 169 pounds. That same person is considered obese if he or she weighs 203-270 pounds (BMI 30-30.9), and morbidly obese 271 pounds and up (BMI 40 and up). To calculate your own BMI, check out nhlbisupport.com/bmi.

Nguyen says he has treated patients with BMIs of 60 and up, putting them at more than 400 pounds.Gastric bypass and the lap band aren’t considered appropriate for patients who are that heavy, because of the increased risk of complications and death. “When a patient comes to see me and they have BMI of 60 or 65, they have to lose weight before I even begin to operate,” Nguyen said. The balloon, which is temporary, could help the heaviest of patients drop enough weight so they could then undergo a regular bariatric procedure.

At the other end of the spectrum, bypass and the lap band are mainly prescribed for those squarely in the morbidly obese category, at or near 40 BMI. “We don’t have any surgical option for 30-35,” he said. Although bypass has been performed on adolescents in the past, patients that young can be particularly vulnerable to complications, Nguyen said. The lap band isn’t FDA-approved for anyone under 18.

The hope is that the balloon will be “effective for a certain patient population we’re not treating right now,” Nguyen said
The balloon was created by ReShape Medical of San Clemente. The startup’s vice president of research and development, Mark Ashby, said the design is an improvement over its predecessors because of it has two balloons. Nguyen said an early version of such a device, the Garren-Edwards gastric bubble introduced in 1984, sometimes would rupture. With no backup membrane, the bubble would slip into the small intestine and cause a dangerous blockage.

Ashby said about 100 of the ReShape balloons have been implanted in patients in Italy and Poland. “The safety feedback and efficacy feedback we’re getting out of this thing is fantastic,” Ashby said. “I don’t want to share a lot of details, but we’re really excited, and we know what to expect in our U.S. study.”

ReShape is footing the bill for the study, paying for the procedures and the intensive follow-up education and treatment for patients during the initial trial phase. That clearly presents the appearance of a conflict of interest. Ashby declined to say how much money has been allocated for the study. “It’s a significant amount of money, because there’s a lot of follow-up involved.”

UCI is recruiting candidates to be among at least 10 subjects for the trial.