Endoscopic Sleeve Gastroplasty

What the procedure involves

The FDA’s device summary puts it this way: “Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic procedure that involves the creation of plications in the stomach to reduce stomach volume. The plications form a sleeve, which reduces stomach capacity and slows gastric emptying.” Plications are folds. A suturing device is passed down the working channel of an endoscope, a corkscrew-shaped helix pulls a bite of stomach wall into the suturing window, and a polypropylene stitch is anchored at both ends. The FDA’s decision covers the system when it is used to place up to eight sutures and cinches.

It is an outpatient endoscopy. The FDA restricts the device to gastroenterologists and surgeons trained on it by the manufacturer, and its own limitations section records that “in the clinical study of the device, patients were required to supplement device use with a low-calorie, healthy lifestyle intervention program” — the procedure was never studied on its own.

The FDA authorisation

On 12 July 2022 the FDA granted De Novo marketing authorisation (DEN210045) to the Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx Systems. The decision created a new Class II device type, "endoscopic suturing device for altering gastric anatomy for weight loss" (21 CFR 876.5983, product code QTD). The authorisation covers adults with obesity with a BMI of 30–50 kg/m² "who have not been able to lose weight, or maintain weight loss, through more conservative measures".

De Novo is the pathway the FDA uses for a low-to-moderate-risk device that has no existing equivalent to be compared against, so the decision both authorised these systems and created the category they belong to. A companion pair of systems authorised in the same decision covers revision of a previous bariatric operation rather than a first procedure.

What the trial found

In a randomised trial of 209 adults aged 21–65 with a BMI of 30–40, average total body weight loss at 52 weeks was 13.6% with ESG plus lifestyle changes against 0.8% with lifestyle changes alone; average excess weight loss was 49.2% against 3.2%. The FDA's own analysis of the same trial reported 13.86% total body weight loss at 52 weeks in the treated group. These figures come from a trial of a procedure and cannot be compared directly with drug-trial or surgical-cohort figures — the study designs and populations differ.

The trial also let the comparison group cross over: after their year of lifestyle changes alone, in which they lost an average of 0.18% of body weight, 73 of them had the procedure and had lost an average of 12.95% a year later — close to what the original procedure group achieved. Fourteen people had their stitches re-tightened after the first year.

The stitches are meant to be permanent, but the stomach can stretch again. In the randomised trial, average total body weight loss was 14.7% at 24 weeks, 13.6% at 52 weeks and 12.2% at 104 weeks among the 59 people followed that long, and at two years 41 of the 60 people still being followed (68%) were holding at least 25% of their excess weight loss. The FDA summary notes that an ESG can be reversed if the person cannot tolerate it, re-tightened if weight returns, or revised to a surgical sleeve gastrectomy.

Side effects and serious events

How it differs from a surgical sleeve

These are two different things with confusingly similar names. The differences below are differences, not a ranking — which one is even a candidate depends on your BMI, your health and what a clinician who can examine you thinks.

Long-term follow-up comes from the Swedish Obese Subjects study, which used older operations (gastric bypass 13%, banding 19%, vertical banded gastroplasty 68%) rather than today's sleeve gastrectomy. In that study mean body weight change was −23% at 2 years, −17% at 10 years, −16% at 15 years and −18% at 20 years in the surgery group, against 0%, +1%, −1% and −1% in matched people receiving usual care.

What it costs

A one-off price is hard to compare with a monthly one. It is worth asking what happens financially if the stitches need re-tightening later, since the trial did that for 14 of the 68 people it followed past a year.

Built with agentic AI tools and not a substitute for medical advice

Last reviewed: September 2026