OverStitch™ Endoscopic Suturing System ESS Indications, Safety, and Warnings
OverStitch NXT™ Endoscopic Suturing System ESS Indications, Safety, and Warnings
OverStitch™ 2-0 Polypropylene Suture Assembly Indications, Safety, and Warnings
Orbera™ Intragastric Balloon Indications, Safety, and Warnings
*Both the OverStitch NXT, OverStitch Endoscopic Suturing Systems (when used for ESG and TORe) and Orbera Intragastric balloon procedures should be conducted by physicians who have undergone specific training by the device manufacturer.
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. 2019;91:1067–1073.
2. Abu Dayyeh BK, Bazerbachi F, Vargas EJ, et al. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): A prospective, multicentre, randomised trial. Lancet. 2022;400:441–451.
3. US FDA Pivotal Study. n = 137 Orbera, n = 136 control, p < 0.001. Most of the patients from the US FDA pivotal study were female and Caucasian. Because of this, data from this study may not accurately represent the same effectiveness and safety profile in Hispanic, African American, or other ethnic populations.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
All photographs taken by Boston Scientific.