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The SimpleStitch Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks).

The SimpleStitch Suturing System ("SimpleStitch SS") is a sterile, single patient-use device that enables endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract using a flexible endoscope. The system includes the following components: SimpleStitch Suture Device, SimpleStitch Suture Cartridge, and SimpleStitch Suture Cinch. The SimpleStitch SS is designed for compatibility with single-channel endoscopes (gastroscopes and colonoscopes) with a minimum working channel inner diameter of 2.8mm. During use, the suturing device/suture cartridge is mounted to the endoscope's exterior; the cinching device goes through the endoscope's working channel. The SimpleStitch SS is available with a USP 2-0 and USP 0 nonabsorbable polyester suture. Tissue is secured using a cinch anchor once tissue approximation is complete.

The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.

The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.