Device Name: Apollo Overstitch for Endoscopic Bariatric Interventions
Author(s): Timothy Snow, DO, FACS, FASMBS
Apollo Endosurgery received FDA approval for Apollo ESG and Apollo REVISE Systems on July 12, 2022.
Primary Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic procedure performed by surgeons and gastroenterologists utilizing the Apollo ESG System for obese patients with a BMI between 30 and 50 who have failed to lose or maintain weight loss through other conservative weight loss methods. ESG is typically an outpatient procedure performed under general anesthesia to reduce the size of the stomach by 60-70% but does not involve a surgical operation or removal of stomach tissue as in Laparoscopic Sleeve Gastrectomy (LSG). The MERIT trial demonstrated the benefits of ESG with findings of significant weight loss of approximately 50% Excess Weight Loss, an excellent safety profile, and improvement of obesity related co-morbidities. Although weight loss appears to be superior with standard surgical bariatric interventions, endoscopic therapy is appropriate for higher risk patients, lower BMI patients, and obese patients who desire a non-operative approach. It also is more effective than standard nutrition, exercise, and weight loss medication therapy. The Apollo ESG system is intended to complement these other bariatric weight loss interventions. Performing ESG does not prohibit further bariatric surgical interventions. Of note, the Apollo ESG system has been used clinically for revisions of LSG, but still requires additional literature for FDA endorsement.
Transoral Outlet Reduction (TORe) is an endoscopic procedure performed by surgeons and gastroenterologists in prior gastric bypass patients who have experienced weight regain or insufficient weight loss. The procedure utilizes the Apollo REVISE System to reduce the size of an enlarged pouch and/or stoma to achieve additional weight loss of approximately 10% Total Body Weight. It is typically performed under general anesthesia, avoids incisions/scars, and is an outpatient procedure. Additional benefits include improvement in obesity related co-morbidities and improved patient compliance with appropriate nutritional lifestyle behaviors. TORe offers an effective revisional weight loss method without formal surgical revision and has decreased risk of adverse events. The Apollo REVISE system is intended to complement other bariatric weight loss interventions.
Both the Apollo ESG and Apollo REVISE Systems consist of suturing instruments, tissue helix, suture anchors, and cinches. These components are provided in different quantities depending on the procedure performed to better accommodate appropriate completion of the designated procedure.
The MERIT Trial is a prospective, multicenter, randomized trial that demonstrates efficacy and safety of endoscopic ESG for durable and meaningful weight loss. The RESTORe Trial demonstrated that TORe could achieve greater weight loss compared to sham treatment. Results were obtained using the Apollo System.
There are no predicate devices to the Apollo ESG and Apollo REVISE Systems. This is the only available FDA approved device for ESG or TORE.
Indications for use:
- The Apollo ESG and REVISE Systems are indicated for use by trained surgeons and gastroenterologists who perform bariatric procedures to facilitate weight loss
- Patients should be adults with a BMI ranging from 30-50
- Patients undergoing ESG via the Apollo ESG System should demonstrate an inability to lose weight or maintain weight loss through other conservative measures
- Patients undergoing TORe via the Apollo REVISE System should demonstrate an inability to lose weight or maintain weight loss through other conservative measures after prior gastric bypass
-A contraindication is present for any endoscopic intervention
-Presence of malignant tissue
-Large hiatal hernia
-Risk of bleeding gastric lesions such as ulcers, erosive gastritis, and vascular malformations
-Uncorrectable coagulopathy or antiplatelet/anticoagulant therapy
-Uncontrolled affective and eating disorders such as anorexia nervosa, binge eating disorder, rumination behavior, avoidant restrictive food intake, and other specified feeding/eating disorders