OverStitch™OverStitch NXT™ Endoscopic Suturing System - box of 3

The OverStitch NXT Endoscopic Suturing System is a sterile, single use device that is used with single channel endoscopes for the endoscopic placement of anchor sutures and approximation of soft tissue, including Endoscopic Sleeve Gastroplasty (ESG) and bariatric revision procedures.

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. 

Indications, Safety, and Warnings

ENDO-1899207-AB