Flexible Endoscopic Suturing System Cleared by FDA

Food and Drug Administration (FDA).

The new system will allow a surgeon to suture soft tissue when doing gastroenterologic procedures by passing the suturing devices through the operating channel of a flexible endoscope. The 2.8 mm gastroplication device passes suture, releases, and secures a pre-tied Roeder knot and then cuts the suture free after approximating tissue or ligating vessels. The system is the product of Pare Surgical, Inc. (Englewood, CO, USA).

During treatment for GERD (gastroenterologic reflux disease), the device can be used to place two small stitches near the lower esophageal sphincter and approximate the tissue to tighten the valve. Stomach contents are then prevented from flowing back up into the esophagus. The procedure can be performed on an outpatient basis without general anesthesia. The system can also be used to ligate large bleeding vessels in the stomach and for suturing openings and vessels in the colon.



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Pare Surgical, Inc.