OverStitch™ Endoscopic Suturing System ESS Indications, Safety, and Warnings
OverStitch NXT™ Endoscopic Suturing System Indications, Safety, and Warnings
OverStitch™ 2-0 Polypropylene Suture Assembly Indications, Safety, and Warnings
*As a condition of the FDA De Novo Authorization of the OverStitch NXT and OverStitch Endoscopic Suturing System for endobariatric procedures (formerly referred to as the Apollo ESG and Apollo REVISE Systems), the devices should only be used for endoscopic sleeve gastroplasty (ESG) or to enable transoral outlet reduction (TORe) as a bariatric revision procedure by gastroenterologists and surgeons who have undergone specific training by the device manufacturer. To fulfill the FDA requirement and special controls for these devices, Boston Scientific is required to independently host courses with consistent training curricula. More information regarding the referenced ESG and TORe revision procedure training courses is available through Boston Scientific.
As of September 2026, Boston Scientific’s OverStitch device is the first and only endoscopic suturing device authorized by the FDA for facilitating weight loss via the TORe procedure. The TORe procedure is performed using the OverStitch Endoscopic Suturing System & OverStitch NXT Endoscopic Suturing System (“OverStitch”).
Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider's responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges, and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved label.
1. Jirapinyo P, Kumar N, AlSamman MA, Thompson CC. Five-year outcomes of transoral outlet reduction for the treatment of weight regain after Roux-en-Y gastric bypass. Gastrointest Endosc. 2020 May;91(5):1067–1073.
2. Jirapinyo, et al. Seven-year Outcomes of Transoral Outlet Reduction for the Treatment of Weight Regain After Roux-en-Y Gastric Bypass. Gastrointestinal Endoscopy. 2020. Subset of patients included in study are also represented in 5-year data.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
All photographs taken by Boston Scientific.
