An outpatient weight-loss procedure now available at University of Colorado Hospital offers a middle ground between diet and exercise and surgeries such as gastric bypass.

UCH is the second hospital in Colorado to offer patients the Orbera system, from Austin, Texas-based Apollo Endosurgery, Inc. It was approved by the FDA in August. Surgeons deliver a deflated silicone balloon to the patient’s stomach via endoscope, then fill it with saline – typically 500 ccs. The filled balloon reduces the available space in the stomach and the amount of food the patient can consume.

There are no restrictions on what patients can eat while the balloon is in the stomach. After six months, surgeons deflate and remove it. Studies showed patients lost on average 22 pounds, three times more than those who completed a behavior modification program without the Orbera device. The Orbera patients also maintained an average weight loss of 19 pounds three months after the device was removed.

Taking on a growing issue

Roughly 1 million Coloradans have a body mass index (BMI) of 30 – the cutoff for adult obesity, according to the Centers for Disease Control and Prevention. The Orbera procedure targets people with BMI in the 30 to 40 range, said Jonathan Schoen, MD, medical director of the Weight Loss Center at UCH. They make up a significant chunk of those classified as obese, Schoen said, and could benefit from an alternative to surgery, he added.

“It could be ideal for patients who need to lose 30 pounds before getting a hip, knee, or spine procedure,” Schoen said. “A bigger target is people who have tried other weight-loss and diet programs without success.”

The Orbera system is “far from a magic bullet,” Schoen emphasized. At UCH, patients will receive multidisciplinary care, including help with lifestyle and dietary changes, during the time the balloon is in place and for six months after the procedure.

“We see it as a powerful jump start to diet and exercise, but as with surgery, patients can regain the weight if they’re not careful,” Schoen said.

Patients may also require support in the first few days following the procedure to treat nausea, retching, and vomiting, Schoen said. But he noted that patients will receive medications to help manage those symptoms. That wasn’t allowed in the trial that led up to FDA approval, he said.

“Those symptoms should resolve by the end of seven days,” said Schoen.

Orbera is new to the United States, but not to the world. Will Jeter, a marketing development manager for Apollo Endosurgery, said the device has been placed in some 220,000 patients in more than 80 countries. At present, patients must pay for the procedure out of pocket – a roughly $7,000 investment – but a third-party company, not connected to the hospital, is available to help with a payment plan at no additional charge, Jeter said.

Placing the device is simple, said Schoen, who learned to do it in a one-day course in San Diego. But the national problem of obesity, which has given rise to Orbera and competitors – including a balloon now being developed that patients ingest without a procedure – defies easy answers, Schoen added. Colorado, for example, still ranks as the leanest state in the nation, but its obesity rate continues to increase, particularly among children.

“As medications, exercise programs, and our knowledge of the disease get better, we can address obesity from many different angles, and combine programs,” Schoen said. “Orbera is another tool for people who are less obese than those who need surgery. We need it as the obesity level continues to increase.”