Device
Device image
Characteristics
FDA status
Reshape Dual Balloon System
ReShape Medical, San Clemente, CA
Two medical-grade silicone spheres joined by a flexible shaft
Each balloon filled with 375–450 ml of saline dyed with methylene blue
Endoscopically placed and removed after 6 months
Approved July 28, 2015
BMI 30–40kg/m2 with one obesity-related comorbidity
Orbera Intragastric Balloon, Apollo Endosurgery, Austin, TX
Medical-grade silicone sphere, filled with 400-700 ml of saline
Endoscoically placed and removed
Approved August 5, 2015
BMI 30–40kg/m2
Obalon Balloon System, Obalon Therapeutics, Carlsbad, CA
Thin polymer ellipse shape
Filled with 250 ml of a nitrogen mix gas
Three balloons administered over 8 to 12-week period
Swallowed and endoscopically removed 6 months after first balloon administration
Approved September 8, 2016
BMI 30–40kg/m2
In the US pivotal multicenter non-blinded randomized controlled trial, 273 patients with a BMI of 30–40 kg/m2 were randomized into one of two groups: Orbera balloon plus behavioral modification program (n = 125, BMI 35.2 ± 3.2 kg/m2) or behavioral modification alone (n = 130, BMI 35.4 ± 2.7 kg/m2) [15]. At 26 and 52 weeks after balloon placement, 71.8% and 45.9% patients in the Orbera balloon group achieved ≥25% EWL compared to 31.9% and 32.6% of patients in behavioral modification alone group. The mean %TBWL at 26 and 52 weeks in the completed analysis was 10.5% and 7.7% in patients who received the balloon compared to 4.7% and 3.9% in patients on behavioral modification alone, respectively [19].
A recent meta-analysis by American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force reported that Orbera meets Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) thresholds for both primary and non-primary bridge therapy for obesity [20]. The PIVI thresholds were published in 2011 from a joint ASGE/American Society for Metabolic and Bariatric Surgery (ASMBS) Task Force which recommended that 25% excess weight loss (EWL) at 12 months and difference between active and control subjects in a randomized controlled trial should be at least 15% EWL for primary therapies [21]. Although there are issues with this white paper, namely, the differential effects of sham-controlled study design and intensity of lifestyle therapy on overall weight loss, the recommendations in this white paper were used to evaluate Orbera. This analysis included 17 studies and 1683 patients for weight loss outcomes with %EWL using random effect model at 12 months at 25.4%. The pooled percent total body weight loss (%TBWL) at 3, 6, and 12 months after Orbera balloon placement was 12.3%, 13.2% and 11.3%.
A few studies have evaluated the utility of sequential or repeated IGB placements. Dumonceau et al. reported outcomes on 19 patients who had repeat IGB therapy (using BIB) per their own request, either immediately (n = 8) or after device-free period (n = 11). Overall, the %EWL at 6 months and 1 year was higher for patients with repeat IGB placement (49.3% vs 30.7% and 40.9% vs 20.8%, respectively), but the difference was not significant at 3 years [22]. Another study reported outcomes on endoscopic BIB placement (600–700 mL saline with 10 mL methylene blue) in 714 consecutive patients. Mean %EWL at 6 months was 41.6 ± 21.8.
Hundred twelve patients underwent second BIB placement, and mean %EWL at second balloon removal was 31.5 ± 23.2 [23]. Genco et al. compared dietary therapy vs second balloon placement after removal of first IGB in 100 patients with obesity (BMI 40 to 44.9 kg/m2). At the end of study period, mean excess BMI loss was significantly higher in patients with a second balloon placement as compared to dietary therapy alone (51.9 ± 24.6% and 25.1 ± 26.2%, respectively) [24].
In addition to weight loss, IGBs have been shown to be associated with improvement in metabolic syndrome and obesity-associated comorbidities. In a multicenter European study including 261 patients, the %EWL was 29.1% at 3 years [25].The rate of hypertension decreased from 29% to 16% at 3 years, diabetes decreased from 15% to 10%, hypercholesterolemia decreased from 32% to 21%, and osteoarthritis decreased from 25% to 13%.
Orbera IGB is generally well tolerated in clinical practice with a low rate of serious adverse events. In the above meta-analysis, pain and nausea were reported in about one third of the patients [20]. Migration and gastric perforation were seen in 1.4% and 0.1%, respectively. The most common nonserious adverse events in the Orbera US pivotal trial include vomiting, nausea, and abdominal pain which occurred in 86.8%, 75.6%, and 57.5% of subjects, respectively. Of note, 30% of subjects either developed or had worsening gastroesophageal reflux disease, which may be a consideration when helping patients choose an IGB. The rate of serious adverse events in the Orbera US pivotal trial was 10%, half of which were device intolerance followed by dehydration (two cases), gastric outlet obstruction (one case), gastric perforation (one case), aspiration pneumonia (one case), and infected balloon (one case), all of which resolved without permanent sequelae [15]. As with any new device or therapy, the rates of adverse events were significantly lower in clinical practice than in original clinical trials, likely related to lack of experience and heightened awareness in the clinical trial phase. Data from a US registry demonstrated a serious adverse event rate requiring hospitalization of 1.7% [26].
The FDA recently issued warning statements regarding hyperinsufflation, pancreatitis, and death, which were not previously identified in the US pivotal trials [27]. Pancreatitis likely results from compression of pancreatic body from the IGB, which resolves with balloon aspiration, but likely affects <0.01% of patients treated with IGB [28]. Moreover, a death rate of 0.08% was previously reported in the ASGE meta-analysis listed above [20], and based on recent publications from Apollo Endosurgery, the current rate is likely <0.01%, which may be related to improved patient selection and adverse event prevention [29].
ReShape Balloon
The ReShape Integrated Dual Balloon System (ReShape Medical, San Clemente, CA, Table 12.1) is unique in design, consisting of two medical grade silicone spheres connected by a flexible shaft. Each balloon is filled with 375–450 mL of saline mixed with methylene blue depending on the height of the patient [30]. Both placement and removal after 6 months of implantation are performed under direct endoscopic visualization. The dual balloon system is designed to provide higher gastric volume occupation and lower chances of migration into the small bowel. The REDUCE pivotal trial was a multicenter double-blind randomized sham-controlled trial comparing ReShape Dual Balloon System plus diet and exercise (n = 187, BMI 35.3 ± 2.8 kg/m2) with sham endoscopy plus diet and exercise (n = 139, BMI 35.4 ± 2.6 kg/m2) [31]. Patients in the balloon group had a significantly higher %EWL at 24 weeks (25.1%) compared with diet and exercise alone group (11.3%) in an intention-to-treat analysis. For completed cases, balloon group had a 7.6%TBWL as compared to 3.6% TBWL for diet and exercise group. For patients that completed a 48-week follow-up, the mean %EWL was 18.8%. Hemoglobin A1c, serum triglyceride concentrations, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure, and diastolic blood pressure significantly decreased in the ReShape Dual Balloon group compared with baseline, with continued improvement compared with baseline in all parameters except for serum triglyceride concentration. Improvement in quality-of-life score and obesity-related quality-of-life scores, as measured by physical function, public distress, self-esteem, sexual life, and work productivity, were significantly higher in the balloon group. Balloon retrieval was required in 9.1% [24] cases due to early intolerance and in 6% due to symptoms associated with ulceration. No gastric perforations, balloon migration, or bowel obstruction was reported. Nausea, vomiting, and abdominal pain were experienced by 54.5%–86.7% of subjects, some of which required emergency room visits (21 cases). The serious adverse event rate was 10.6%; however, the majority of serious adverse events were due to hospitalization or ER visit for intravenous treatment of post-placement accommodative symptoms (nausea, vomiting, abdominal pain). Non-accommodative serious adverse events were uncommon and included esophageal mucosal tear during retrieval (one case), GE junction ulcer (one case), contained cervical esophageal perforation (one case), and pneumonitis post retrieval (one case), all of which were managed conservatively. Gastric ulceration, mostly near incisura, occurred in 39% of patients in the initial trial phase, which was reduced to 10% after subtle changes in balloon distal tip design. However, it is to be noted that gastric ulceration rates were highest with ReShape balloon as compared to Orbera or Obalon balloon, which may be a factor in choosing the right balloon for patients at high risk for gastric ulcers.
Similar to Orbera balloon, weight loss in clinical practice is higher with ReShape balloon as compared to the above reported clinical trial. Lopez-Nava et al. reported outcomes in 60 patients who underwent ReShape dual intragastric balloon system placement, filled with a total of 900 cc fluid, for 6 months. The study reported 15.4% TBWL and 47.1% EWL, compared to 7.6% TBWL and 25.1% EWL in the REDUCE trial. Only one early removal for patient intolerance, one early deflation without migration, and one gastric perforation were reported [32].
The overall weight loss in REDUCE trial was lower as compared to the Orbera balloon trial. This is likely the result of difference in trial design as the Orbera trial was not sham controlled, and subject knowledge of intervention may be associated with higher weight loss. A recent retrospective cohort study compared 14 Orbera and 26 ReShape balloon cases [33] and showed similar weight loss results despite higher baseline BMI in Orbera group (10.5% ±1.8% TBWL in ReShape and 10.2 ± 1.9% TBWL in Orbera group). The overall adverse events requiring intervention (defined as early IGB removal due to intolerance, IGB deflation requiring replacement, and upper gastrointestinal symptoms requiring emergency room visit or inpatient admission) were significantly more common in Orbera patients (43% vs 12%, P = 0.04) [33]. Another recent study compared tolerability of Orbera and ReShape IGBs in a retrospective study of 100 patients. The overall rate and severity of accommodative symptoms (nausea, vomiting, and abdominal pain) were similar between the two groups, but duration of nausea and vomiting was longer in Orbera balloon group. Overall weight loss was similar for both groups though early retrieval rate due to intolerance was higher in Orbera group (15.7%) as compared to ReShape group (7.8%) [34]. These data suggest that the weight loss seen with ReShape Dual Balloon is the same as the Orbera balloon in clinical practice and that the ReShape Dual Balloon may be slightly better tolerated by patients; however more data is necessary to understand these differences.
Obalon Balloon
The Obalon Balloon System (Obalon Therapeutics, Carlsbad, CA, Table 12.1) is the most recent FDA-approved IGB. The Obalon Balloon System consists of a thin polymer Elipse balloon filled with 250 cc of a proprietary nitrogen gas mixture. The Obalon balloon is enclosed inside a 6-gram dissolvable capsule, attached to a thin catheter. The balloon is swallowed in the capsule form, and placement in stomach is confirmed using fluoroscopy and pressure monitor readings using a manometer connected to the catheter. As the capsule dissolves, the pressure reading on manometer drops under 7 KPa. After confirming on fluoroscopy, balloon can be inflated (9–13 KPa) and catheter is removed. Three balloons are administered over an 8- to 12-week period, followed by endoscopic removal of all balloons at 6 months from the first balloon placement [16].
The pivotal US multicenter double-blind randomized sham controlled trial (SMART trial) compared Obalon IGB plus lifestyle counseling (n = 198, BMI 35.1 ± 2.7 kg/m2) to a sham control group of non-balloon capsules and lifestyle counseling (n = 189, BMI 35.4 ± 2.7 kg/m2). For the per protocol analysis, %TBWL at 24 weeks was 6.86% ± 5.1% in the Obalon IGB plus lifestyle counseling group as compared to 3.59 ± 5% in the control group. For the modified intention-to-treat analysis (including patients who swallowed at least 1 capsule), %TBWL at 24 weeks was 6.6 ± 5.1% in the treatment group and 3.4 ± 5% in the control group (p = 0.0354). For the completer analysis (including patients who completed study testing through week 24), %TBWL at 24 weeks was 7.1 ± 5.0% in the Obalon IGB plus lifestyle counseling group as compared to 3.6 ± 5.1% in the control group, p = 0.0085) In addition to weight loss, significant improvement was noticed in systolic blood pressure, fasting glucose, LDL cholesterol and triglyceride levels in the intervention group [35].
The most common nonserious adverse events in the SMART trial included abdominal pain, nausea, and vomiting occurring in 72.6%, 56.0%, and 17.3% of subjects respectively, with 99.6% of all nonserious adverse events reported as mild or moderate. Only one serious adverse event of a bleeding gastric ulcer was reported in a patient taking high dose NSAIDs which was prohibited per protocol [36].
Obalon balloon has been used off-label in the pediatric and adolescent population. De Peppo et al. reported outcomes of a small study including 17 children with obesity (BMI > 30 kg/m2) and a mean age of 13.6 years (Range 9.9 to 17.1). The overall %EWL was 20.1 ± 9.8 (range 2.3 – 35.1) with significant reductions in mean BMI (35.27 ± 5.89 to 32.25 ± 7.1), mean excess weight (36.2 ± 15.9 to 29.4 ± 18.3 kg) and waist circumference (109 ± 12.3 cm to 99 ± 10.5 cm) [37]. No studies comparing the Obalon Balloon System to the ReShape or Orbera balloons have been published to date.
Spatz Balloon
Investigational intragastric balloons in the United States
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