Two products approved by FDA will be available in 2017.
One system is the ReShape Dual Balloon, which is inserted in the stomach through an endoscopic procedure and filled with saline (salt water). The balloons remain in the stomach for six months and help reduce hunger, so patients feel satisfied with smaller portions. During the six months and for the six months after the balloon is removed, patients receive comprehensive counseling and support services that include frequent in-office coaching sessions.
Prior to receiving FDA approval, the ReShape Integrated Dual Balloon System underwent rigorous testing and academic studies. According to one study, patients who had the ReShape procedure lost two times as much weight as a group who only received diet and exercise coaching. In a study conducted in Europe, ReShape patients, on average, lost 47% of their excess weight and maintained 98% of their weight loss at one year.
Patients who used the FDA-approved Obalon balloon system also lost almost twice as much weight as patients who adopted diet, exercise, and lifestyle changes, and they maintained their weight loss through 12 months, according to research presented at ObesityWeek.
The Obalon Balloon System (Obalon Therapeutics) involves three intragastric balloons that are folded within capsules, swallowed and inflated with gas by a micro-catheter once they reach the stomach. They are placed sequentially over 3 months and are then endoscopically removed after 6 months, throughout which patients adhere to a diet and behavior modification program.
Preliminary data were presented at DDW 2016, and the FDA has since approved the product for adults with obesity for whom diet and exercise has failed.
New follow-up data shows “the significant weight loss achieved with the Obalon 6-Month Balloon System is maintained at 12 months,” according to Aurora D. Pryor, MD, chief of bariatric, foregut and advanced GI surgery at Stony Brook University. “This combination of lifestyle modification and balloon therapy provides a new low-risk option for patients struggling with obesity.”
Pryor and colleagues performed a double blind, randomized, sham controlled trial comprising 387 adults with obesity at 15 sites in the U.S., 366 of whom swallowed at least two balloons and completed 18 weeks of therapy.
In the first phase of the trial, the researchers randomly assigned 185 individuals to receive the Obalon balloons and 181 to receive sham capsules, paired with 25 minutes of lifestyle therapy every 3 weeks. Participants were unmasked at week 24 and the balloons were then endoscopically removed.
The mean total weight loss at 6 months was 6.9% ± 5% in the Obalon group compared with 3.6% ± 5% in the sham group (3.3% difference; P = .026). Moreover, the treatment group had 25.2% ± 19.2% excess weight loss at 6 months.
In the second phase of the trial, 171 patients who lost weight with the Obalon balloon were then followed for six additional months after removal, during which time they continued with the lifestyle intervention. At the end of phase 1, mean total weight loss was 7.6% ± 4.4% and excess weight loss was 28% ± 17.2% in these patients; and at the end of phase 2, these figures were 6.8% ± 6.5% and 24.7% ± 24.4%, respectively.
Device-related adverse events included mostly abdominal cramping and nausea, which occurred in 90.8% of patients and were reported to be mild or moderate 99.6% of the time. No unexpected device-related events occurred, but one serious adverse device-related event — a gastric ulcer related to NSAID use — occurred during the treatment period.
Both systems demonstrated a favorable safety profile, and no recovery time was needed.
These new treatments are expected to be available early next year to physicians who complete a training program.
- An intragastric balloon system is an effective and safe addition to lifestyle interventions for promoting weight loss in obese patients.
- The group that underwent the balloon procedure saw results that were two times as much weight loss as a group who only received diet and exercise coaching.
- Device-related adverse events included mostly abdominal cramping and nausea, which occurred in 90.8% of patients, were reported to be mild or moderate 99.6% of the time.
Presented at: ObesityWeek 2016; Oct. 31-Nov. 4, 2016; New Orleans.