Apollo Endosurgery's intragastric balloon doubled weight loss compared to diet and exercise alone during its pivotal clinical trial, the company said during the Digestive Disease Week conference in Washington, DC, as it seeks to be the first to sell a weight-loss balloon in the U.S.
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| Orbera intragastric balloon--Courtesy of Apollo Endosurgery |
In the 12-month trial of 255 patients, patients on the Orbera intragastric balloon experienced a 40% mean excess weight loss at 6 months (meaning patients shed 40% of their excess weight), and 10.54% overall weight loss, compared to 4.71% for the control group.
Both arms received a yearlong behavioral modification program, while the treatment group also received the Orbera, which is removed from the stomach after 6 months. Apollo said the Orbera group was able to maintain the weight loss in the 6 months following the device's removal and also performed better than the control group through 12 months.
"The results of this study prove that Orbera can be an outstanding tool to aid weight loss and support sustainable, healthy habits, even after it has been removed," said Dr. Barham Abu Dayyeh, gastroenterologist and advanced endoscopist at The Mayo Clinic, in a statement.
Although the CE-marked device has been used in more than 200,000 real-world patients, the data is exciting because it is the first about the use of the device in the U.S., said Apollo president and founder Dennis McWilliams in an interview.
More details of the study are available in Gastrointestinal Endoscopy.
The company is expecting the FDA's decision on the product's PMA application soon, said McWilliams. He said the PMA was submitted in April 2014, a few months before that for the rival Integrated Dual Balloon from ReShape Medical, which delivered excess weight loss of an average of 28% during its clinical trial.
According to the Apollo website, the Orbera is made of silicon. Following endoscopy to check for abnormalities in the stomach, the device is inserted into the organ through the mouth via delivery catheter in a 30-minute procedure. Then, the balloon is inflated to the size of a grapefruit with sterile salt water through a self-sealing valve. It reduces appetite by taking up space in the stomach.
There are several surgical procedures for weight loss, but adoption has been low because of patients' aversion to surgery and the associated risks, such as malnutrition following duodenal switch surgery, which involves removal of most of the stomach.
McWilliams said that while obesity has skyrocketed, the number of surgeries to treat it is staying fairly constant, and used on less than 1% of the eligible patient population. The upcoming class of intragastric balloons is "opening up a whole new category in this space that's less invasive," he said, because it provides an incisionless, minimally invasive, procedural (rather than surgical) option. Some inconvenience is still present though. During the weeklong recovery period following the installation of the Orbera, patients must eat a liquid diet and may feel nausea or experience vomiting.
Patients are supposed to receive coaching for one year to encourage a healthy lifestyle after they receive the balloon, Apollo says.
The company acquired the Orbera when it bought Allergan's obesity intervention business for up to $110 million in 2013. The deal also gave Apollo Allergan's struggling Lap-Band franchise, which consists of a band implanted around the stomach. It can cause food intolerance and other long-term complications, but McWilliams said its struggles have less to do with clinical complications and more to do with the rise of competitive procedures and neglect of the business. "Frankly, Allergan didn't really pay attention to the business," he said.
Regardless, Lap-Band will always suffer from patients' dislike of complex surgeries. That's why several companies including Apollo are seeking to expand the obesity device arena by introducing intragastric balloons. Allurion Technologies claims its investigational device is procedureless because the balloon is inserted into the body via a swallowed capsule and excreted out of the body at the end of the treatment period. This device is further away from FDA approval than Orbera and Integrated Dual Balloon.
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