Apollo Endosurgery, a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, has announced that study investigators of the Multi-Center ESG Randomized Interventional Trial (MERIT) presented positive outcomes.
Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, presented the data at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) during the “Top 10 Papers at IFSO” session.
Key highlights include:
- Study Methods: The trial enrolled 208 patients across nine US centers. Patients were randomized between ESG and moderate lifestyle modification controls. Average BMI at enrollment was 35.7 ±2.6 kg/m2. The primary efficacy endpoint was Percent Excess Weight Loss (%EWL) and responders were defined as those achieving at least 25% EWL at 12 months. The study targeted a serious adverse event rate of <5%, which was the primary safety endpoint. Patients were followed for 24 months, with control subjects given the option to cross over at 12 months.
- Efficacy: Patients undergoing Endoscopic Sleeve Gastroplasty (ESG) demonstrated an excess body weight loss (EWL) of 49.2% (+32%) at 12 months, which was a 45% difference in %EWL compared to patients undergoing moderate intensity lifestyle modification. Furthermore, 77% of subjects undergoing ESG achieved at least 25% EWL, and percent total body weight loss (%TBWL) for this responder group was 16.3% (+7%).
- Impact on Co-Morbidities: Patients undergoing ESG demonstrated improvements in diabetes, hypertension, and metabolic syndrome compared to controls, as well as improvement in, and no onset of, gastroesophageal reflux disease (GERD).
- Safety: ESG met the primary safety endpoint with a rate of serious adverse events of 2.0% (3/150), all of which resolved and did not require intensive care or surgical intervention[i].
- Durability: Despite the Global Pandemicduring year-two, cross-over patients achieved similar results to the initial treatment group and those that had undergone treatment maintained the vast majority of their weight loss at 24 months.
“The MERIT outcomes are compelling, and the medical community is eager to embrace new treatment options to address the global obesity problem,” said Dr. Abu Dayyeh. “Endoscopic Sleeve Gastroplasty offers a scalable, safe, effective, organ-sparing solution that can be performed in an outpatient facility by either a gastroenterologist or a bariatric surgeon. In addition, the ESG procedure can be combined with other therapeutic options to further enhance patient outcomes.”
ESG is a minimally-invasive (nonsurgical) weight loss procedure that uses the OverStitch™ Endoscopic Suturing System to reduce the volume of a person’s stomach. The MERIT data adds to a larger body of evidence for ESG of more than 200 publications and abstracts reporting positive outcomes in over 6,500 patients[ii].
Worldwide obesity has nearly tripled since 1975, with more than 650 million people now considered obese[iii]. In the U.S., more than 100 million adults are obese, greater than 40 percent of the adult population[iv]. Obesity related conditions including heart disease, stroke, type 2 diabetes, and certain types of cancer are among the leading causes of preventable, premature death. Obesity costs the U.S. health care system more than $170 billion a year[v]. Yet, less than one percent of obese patients are treated with bariatric surgical weight loss procedures each year.
“This is a significant milestone for Apollo in our mission to dramatically impact chronic obesity and obesity-related health conditions that continue unabated around the world,” said Chas McKhann, president and CEO of Apollo Endosurgery. “The results of MERIT support that the ESG procedure offers a compelling value proposition of clinically significant weight loss from a safe, convenient, outpatient procedure. We look forward to our continued work with the FDA, following our recent De Novo 510(k) submission, as we seek regulatory clearance to recognize ESG as a potential treatment option for those living with obesity.”
[i] There were three serious adverse events (2%): a peri-gastric abscess, bleeding, and malnutrition. All were treated successfully by endoscopy without need for intensive care or formal surgery. In addition, while most patients received the ESG as an outpatient procedure, six patients (4%) were briefly hospitalized for non-serious adverse events to manage their difficulties with accommodation of reduced gastric volume.
[ii] Apollo Endosurgery internal meta-analysis of published ESG studies
[iii] World Health Organization (June 2021)
[iv] Centers for Disease Control and Prevention (February 2020)
[v] U.S. News and World Report (March 2021)
Source: Apollo Endosurgery.