Status checked on October 6, 2026 accessdata.fda.gov
Endoscopic sleeve gastroplasty (ESG) explained: how the stitched sleeve works, FDA De Novo status and indication, MERIT trial results, side-effect rates, ESG vs surgical sleeve, cost and insurance.
Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.
Key facts
- Type
- Medical
- Approach
- Endoscopic
- Sedation
- Sedation or general anesthesia for endoscopy (ask your team which is used)
- Permanence
- Revisable
- Device status
- APOLLO ESG, ESG SX, REVISE and REVISE SX Systems (Apollo Endosurgery) · De Novo
- Performed by
- Bariatric surgery
Key takeaways
- The FDA granted De Novo authorization to the Apollo ESG system on July 12, 2022, for adults with a BMI of 30 to 50.[1]
- In MERIT, total body weight loss at 52 weeks was 13.6% with ESG versus 0.8% with lifestyle changes alone.[3]
- Nausea (70%) and abdominal pain (68%) were the most common side effects, usually resolving within 30 to 60 days.[2]
- In matched U.S. registry patients, 6-month weight loss was 12.3% after ESG and 18.5% after surgical sleeve.[6]
In short: Endoscopic sleeve gastroplasty (ESG) narrows the stomach with stitches placed from the inside, using a camera passed through the mouth, so there are no incisions and nothing is removed. The FDA granted the device used for it, the Apollo ESG system, De Novo authorization on July 12, 2022, for adults with a BMI of 30 to 50 who have not lost weight, or kept it off, with more conservative measures. In the MERIT randomized trial, people lost an average of 13.6% of their body weight in a year with ESG plus lifestyle changes, versus 0.8% with lifestyle changes alone. Weight loss is smaller than with surgical sleeve gastrectomy, and side effects such as nausea and pain are very common in the first weeks.
This page explains how ESG is done, the device’s FDA authorization and who it is indicated for, the trial results and side-effect rates from the FDA’s review, how it compares with the surgical sleeve, cost and insurance, and questions to ask. InstaTuck does not sell or arrange procedures; this is consumer education. Research the options, talk with a licensed doctor and get evaluated before any treatment.
ESG at a glance
- July 12, 2022FDA De Novo authorization of the Apollo ESG system (DEN210045)FDA De Novo database
- 13.6%average total weight loss at 52 weeks vs 0.8% with lifestyle alone (MERIT)The Lancet 2022
- 2%ESG-related serious adverse events in MERIT (3 of 131)The Lancet 2022
- 4,587ESG procedures in the U.S. in 2023ASMBS estimates
Checked on October 6, 2026
What ESG is
In ESG, a gastroenterologist or surgeon passes an endoscope through the mouth into the stomach and uses an attached suturing device to place a series of full-thickness stitches along the stomach wall. Pulling the stitches tight folds the stomach into a narrower tube, a “sleeve,” reducing its volume. The FDA’s review describes the result as plications (folds) that form a sleeve, which reduces stomach capacity and slows gastric emptying. Unlike a surgical gastric sleeve, no part of the stomach is removed and there are no cuts in the abdomen. The FDA review notes from the published literature that an ESG can be reversed if a person cannot tolerate it, and re-tightened if weight begins to return.
ESG is still a small share of weight-loss procedures. ASMBS estimates 1,500 ESGs in the U.S. in 2020 and 4,587 in 2023, compared with more than 157,000 surgical sleeves. The FDA lists endoscopic suturing devices as one of its three types of weight-loss devices, alongside gastric bands and balloons.
FDA status and who it is indicated for
The FDA granted De Novo classification (DEN210045) to the APOLLO ESG, ESG SX, REVISE and REVISE SX systems from Apollo Endosurgery on July 12, 2022, creating the device type “endoscopic suturing device for altering gastric anatomy for weight loss.” According to the FDA’s decision summary, the ESG systems are intended for use by trained gastroenterologists or surgeons who perform bariatric procedures, to facilitate weight loss in adults with obesity with a BMI of 30 to 50 who have not been able to lose weight, or maintain weight loss, through more conservative measures. The REVISE systems are for adults with a BMI of 30 to 50 who need a transoral outlet reduction as a revision of an earlier bariatric operation (see revision surgery). In the clinical study, patients also followed a low-calorie, healthy lifestyle program, and only doctors trained by the manufacturer should use the device.
The decision summary lists these contraindications: situations where endoscopy is not safe; malignant tissue; a large hiatal hernia; possible bleeding lesions in the stomach such as ulcers, erosive gastritis, varices or vascular malformations; mood disorders not under medical supervision or not responding to treatment, and all eating disorders (including binge eating disorder); pregnancy; and bleeding disorders or blood thinner and antiplatelet therapy that cannot be corrected. Your doctor will review the full labeling.
What the MERIT trial showed
MERIT, published in The Lancet in 2022, randomized 209 adults with class 1 or 2 obesity at nine U.S. centers to ESG plus lifestyle changes or lifestyle changes alone. At 52 weeks, total body weight loss averaged 13.6% with ESG and 0.8% in the control group. Average excess weight loss was 49.2% versus 3.2%, and 77% of ESG participants reached at least 25% excess weight loss, versus 12% of controls. Among ESG participants with weight-related conditions, 80% improved in at least one. The authors reported that weight loss was maintained at 104 weeks.
| Item | ESG plus lifestyle | Lifestyle alone |
|---|---|---|
| Total body weight loss | 13.6% | 0.8% |
| Excess weight loss | 49.2% | 3.2% |
| Reached 25%+ excess weight loss | 77% | 12% |
| Lost 10%+ of body weight (FDA review) | 64.7% | 4.5% |
Responder rate (10% or more) from the FDA's analysis of trial completers: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN210045.pdf
Source: Abu Dayyeh BK et al., The Lancet 2022 (MERIT); FDA De Novo decision summary DEN210045 (checked on October 6, 2026)
The FDA’s review adds detail on the time course: weight loss began in the first week, reached 14.7% at 24 weeks, then leveled off with minimal regain at 52 weeks (13.9% in the FDA’s analysis). People in the control group who later crossed over to ESG lost 13.0% in the following year. The response held across subgroups in the FDA’s review, including people with type 2 diabetes and with high blood pressure.
Side effects
Almost everyone has some symptoms after ESG. In the FDA’s review of the 150 people who had the procedure in the trial, 92% had at least one device- or procedure-related adverse event. The most common digestive events were nausea, abdominal pain, belching, vomiting, constipation, reflux and diarrhea; they usually started in the first week and resolved within 30 to 60 days.
Serious risks
Serious problems are less common but real. In MERIT, ESG-related serious adverse events occurred in 2% (3 of 131) of participants. In the FDA’s broader safety count, which includes crossover patients, 11 of 150 (7.3%) had a serious adverse event, most often nausea, abdominal pain and vomiting needing a hospital stay for fluids and medicines; seven people were hospitalized after the procedure for early symptoms. Single cases included an abdominal abscess with fluid around the lung, bleeding at a marking site, suspected malnutrition and a tear in the esophagus during a procedure, which was stopped. MERIT reported no deaths. Outside the trial, the FDA reviewed 75 medical device reports involving the same suturing system used for ESG or outlet reduction: the most frequent problem was internal organ perforation (5 reports), followed by abdominal pain and bleeding (2 each), with single reports of death, sepsis, esophageal tears, a collapsed lung, peritonitis, a blood clot in the lung and a liver abscess. Such reports cannot give rates, but they show what can go wrong. As with any procedure under sedation or anesthesia, tell the team about all your medicines, especially GLP-1 medicines, which slow stomach emptying and carry label warnings about aspiration during deep sedation.
Who weighs ESG, and against what
ESG sits between lifestyle treatment and medicines on one side and surgery on the other. Its indication starts at a BMI of 30, the same level at which the 2022 ASMBS and IFSO guidelines say surgery should be considered for people with metabolic disease, and it extends to 50. People who look at ESG often want to avoid incisions or the permanent removal of stomach tissue, are not eligible for or do not want surgery, or want an option that does not require a long-term medicine. Others compare it with FDA-approved medicines such as Wegovy and Zepbound, which have their own trial results and are labeled for long-term use; see the GLP-1 medicines guide.
The FDA review also lists situations where ESG should not be done, including a large hiatal hernia and eating disorders, and the device should only be used by doctors trained by the manufacturer. Because ESG is newer, there is less long-term information than for surgery; MERIT reported maintained weight loss at 104 weeks. A good consultation should cover what happens if weight returns (the FDA notes an ESG can be re-tightened) and what your options would be if you later wanted surgery.
ESG vs the surgical sleeve
ESG and sleeve gastrectomy both make the stomach smaller, but they are different treatments. A 2026 analysis in the Journal of the American College of Surgeons, using 2023 data from the national MBSAQIP registry, matched 417 ESG patients with 3,336 surgical sleeve patients. At 6 months, weight loss averaged 12.3% after ESG and 18.5% after the sleeve, while readmissions (3.8% vs 1.6%) and reoperations (1.0% vs 0.3%) were higher after ESG. This was an observational registry study over a short period, not a randomized trial.
| Item | ESG | Surgical sleeve |
|---|---|---|
| Weight loss | 12.33% | 18.51% |
| Readmission | 3.80% | 1.60% |
| Reoperation | 1% | 0.30% |
417 ESG and 3,336 sleeve patients from the 2023 MBSAQIP follow-up file; observational.
Source: Leslie ZD et al., J Am Coll Surg 2026, as summarized in ACS Brief, June 23, 2026 (checked on October 6, 2026)
| ESG | Surgical gastric sleeve | |
|---|---|---|
| Approach | Through the mouth; no incisions | Laparoscopic surgery under general anesthesia |
| Stomach removed | None; stitched into a tube | About 80% removed |
| Indicated or recommended for | Device indication: BMI 30 to 50 | 2022 guidelines: BMI over 35, or 30 to 34.9 with metabolic disease |
| Weight loss in the main studies | 13.6% at 1 year (MERIT) | 25.2% at 1 year, 18.8% at 5 years (PCORnet) |
| Long-term data | Limited (MERIT reported 104 weeks) | Randomized data to 10 years |
| Medicare | Not among the nationally covered procedures in NCD 100.1 | Covered at local contractor discretion |
Recovery and life after ESG
Because there are no incisions, recovery from the procedure itself is usually quicker than after surgery, but the first weeks bring nausea and cramping for most people, and the stomach holds much less. In MERIT, ESG was combined with a lifestyle program, and the device’s limitations state that patients in the study were required to follow a low-calorie, healthy lifestyle program. Ask your team how long you will stay, which foods and textures to expect and when, how protein and fluids will be managed, and which medicines you will need for nausea and acid. Our life after bariatric surgery guide covers eating stages and follow-up in general, and the protein calculator helps you plan protein.
Cost and insurance
Endoscopic sleeve gastroplasty is not among the procedures Medicare covers nationally under its bariatric surgery coverage decision (NCD 100.1, checked on October 6, 2026), and coverage by private plans varies, so many people pay themselves. We did not find a national price from an official or survey source we could verify today, so we do not publish one. Ask for a written quote covering the evaluation, anesthesia or sedation, the procedure, the facility, medicines, the lifestyle program and follow-up visits, and what happens if a repeat or revision is needed. See our costs hub and insurance hub.
Alternatives and choosing a provider
Other options include the temporary gastric balloon, surgery such as the gastric sleeve and gastric bypass, and FDA-approved medicines such as Wegovy and Zepbound; the medical procedures hub compares them all, and GLP-1 vs bariatric surgery covers the medicine-or-procedure question. Ask any ESG provider how many procedures they have done, whether they completed the manufacturer’s training, which device they use, their complication and readmission rates, and who handles problems after hours. Our bariatric surgeons guide explains how to check credentials.
Who explores it
Device indication (FDA De Novo DEN210045): adults with obesity with a BMI of 30 to 50 who have not been able to lose weight, or maintain weight loss, through more conservative measures; used with a lifestyle program by trained gastroenterologists or surgeons.
How it works
Full-thickness stitches placed through an endoscope fold the stomach into a narrower sleeve, reducing its capacity and slowing gastric emptying (FDA DEN210045). No part of the stomach is removed; the stitches are intended to be permanent.
Typical results
MERIT (Lancet 2022): 13.6% average total body weight loss at 52 weeks vs 0.8% with lifestyle alone; 49.2% excess weight loss; maintained at 104 weeks. MBSAQIP 2023 matched data: 12.3% at 6 months vs 18.5% after surgical sleeve.
Ranges from published studies; individual results vary.
Recovery
Nausea, abdominal pain and other digestive symptoms usually start in the first week and resolve within 30 to 60 days (FDA review). Staged diet and a lifestyle program follow.
Risks
- Nausea (70.0%), abdominal pain (68.0%), belching (51.3%), vomiting (49.3%), constipation (45.3%), reflux (36.7%), diarrhea (15.3%) (FDA review, 150 patients)
- Serious adverse events: 2% in MERIT; 7.3% in the FDA safety count including crossover patients
- Hospital stays for early nausea and vomiting
- Rare: abscess, bleeding, malnutrition, esophageal tear; post-market reports include perforation and, rarely, death
- Readmission 3.8% and reoperation 1.0% at 6 months in U.S. registry data
FDA authorization
| Device | Pathway | Number | Date |
|---|---|---|---|
| APOLLO ESG, ESG SX, REVISE and REVISE SX Systems (Apollo Endosurgery) | De Novo | DEN210045 | July 12, 2022 |
Clearance (510(k)) means the FDA found a device similar to one already on the market; it is not the same as approval.
Cost and insurance
Not among the procedures Medicare covers nationally under NCD 100.1; private coverage varies and many people pay themselves. No verified national price was found.
Insurance information checked on October 6, 2026.
Advantages and limitations
Advantages
- No incisions and no part of the stomach removed
- Device indication starts at BMI 30
- 13.6% weight loss at 1 year vs 0.8% with lifestyle alone in a randomized trial
Limitations
- Less weight loss than a surgical sleeve in registry data (12.3% vs 18.5% at 6 months)
- Nausea and pain are very common in the first weeks
- Long-term data are limited compared with surgery
- Often not covered by insurance
Choosing a provider
Check board certification, where the procedure is done (accredited facility), how many of these procedures the provider performs, and what follow-up care is included. Find a Bariatric Surgeon: credentials, accredited centers and what to ask
Alternatives
FDA approved for weight managementPrescriptionInjectionWegovy (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · Weekly
FDA approved for weight managementPrescriptionInjectionZepbound (tirzepatide): uses, side effects, cost and FDA statusTirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro) · Injection · Weekly
SurgicalGastric Sleeve Surgery: eligibility, results, risks and costSurgical · 2+ weeks
Medical deviceEndoscopicGastric Balloon: the endoscopic, temporary optionEndoscopic · 1-3 daysRelated procedures
Research mentioning it
A History of Bariatric Surgery: From 1954 to the SleeveA history of bariatric surgery from the original papers and FDA and Medicare records: the 1954…
Weight-Loss Devices FDA Has Authorized: Balloons, Capsules and MoreEvery weight-loss device the FDA has authorized, from the Lap-Band to swallowable balloons and gel capsules:…
Questions to Ask a Bariatric Surgeon (and How to Check Credentials)The questions to ask a bariatric surgeon and how to check credentials: American Board of Surgery…Related guides
Medical Weight-Loss Procedures: surgical, endoscopic and devicesMedical weight-loss procedures compared: sleeve, bypass, duodenal switch, band, revision, endoscopic sleeve gastroplasty and gastric balloons…
Find a Bariatric Surgeon: credentials, accredited centers and what to askHow to find a qualified bariatric surgeon: board certification, MBSAQIP accredited centers, the evaluation steps, risks,…Tools for this topic
Questions to ask a professional
- Do I fit the device indication, and do I have any contraindication such as a hiatal hernia?
- How many ESGs have you done, and did you complete the manufacturer's training?
- What weight loss is realistic for me compared with a surgical sleeve or medicine?
- What is the plan for nausea and pain in the first weeks, and when can I eat solids?
- What is the total cost, and what happens if I need a repeat procedure or surgery later?
Frequently asked questions
Is ESG FDA approved?
The device used for ESG, the Apollo ESG system, received FDA De Novo authorization on July 12, 2022, for adults with obesity and a BMI of 30 to 50. De Novo is the pathway for new, moderate-risk device types.
How much weight do you lose with ESG?
In the MERIT trial, average total body weight loss was 13.6% at one year, versus 0.8% with lifestyle changes alone, and the authors reported it was maintained at two years.
Is ESG the same as a gastric sleeve?
No. A surgical sleeve removes about 80% of the stomach. ESG stitches the stomach into a narrower shape from the inside, without incisions or removing tissue, and gives less weight loss on average.
What are the side effects of ESG?
In the FDA review, nausea (70%), abdominal pain (68%), belching (51%), vomiting (49%), constipation (45%) and reflux (37%) were most common, usually resolving within 30 to 60 days. Serious events occurred in 2% in MERIT.
Who can have ESG?
The FDA indication is adults with a BMI of 30 to 50 who have not lost weight or kept it off with more conservative measures. Contraindications include a large hiatal hernia, bleeding lesions, eating disorders and pregnancy.
Is ESG reversible?
No tissue is removed. The FDA review of the published literature states that an ESG can be reversed if a patient cannot tolerate the sleeve, and can be re-tightened if weight starts to return. Ask your doctor what that would involve for you.
Does insurance cover ESG?
ESG is not among the procedures Medicare covers nationally under NCD 100.1, and private coverage varies. Ask your plan and get a written quote.
Can ESG be done after bariatric surgery?
A related procedure with the REVISE system, transoral outlet reduction, is indicated as a revision after an earlier bariatric operation. See revision surgery.
References
- De Novo DEN210045: APOLLO ESG, ESG SX, REVISE and REVISE SX Systems. U.S. Food and Drug Administration, 2022. (accessed October 7, 2026) Government page
- De Novo Classification Request decision summary, DEN210045. U.S. Food and Drug Administration. (accessed October 6, 2026) Drug label
- Abu Dayyeh BK, et al.. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. The Lancet, 2022. doi:10.1016/S0140-6736(22)01280-6 · PMID 35908555 (accessed October 7, 2026) Randomized trial
- Weight-Loss and Weight-Management Devices (content current as of 2026-03-12). U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
- Estimate of Bariatric Surgery Numbers, 2011-2023. American Society for Metabolic and Bariatric Surgery. (accessed October 7, 2026) Society statement
- Sleeve Gastrectomy Shows Advantages over Endoscopic Sleeve Gastroplasty (ACS Brief, on Leslie ZD et al., J Am Coll Surg 2026). American College of Surgeons, 2026. (accessed October 7, 2026) News (reported facts only)
- Arterburn D, et al.. Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study. Annals of Internal Medicine, 2018. doi:10.7326/M17-2786 · PMID 30383139 · NCT02741674 (accessed October 6, 2026) Other
- Eisenberg D, Shikora SA, Aarts E, et al.. 2022 ASMBS and IFSO: Indications for Metabolic and Bariatric Surgery. Surgery for Obesity and Related Diseases, 2022. doi:10.1016/j.soard.2022.08.013 · PMID 36280539 (accessed October 6, 2026) Guideline
- National Coverage Determination 100.1: Bariatric Surgery. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page
- WEGOVY (semaglutide) injection and tablets: prescribing information. Novo Nordisk, via DailyMed, 2026. (accessed October 7, 2026) Drug label
Facts checked on October 6, 2026
Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.