An Endosurgical Operating System: Initial Human Experience in Endolumenal and NOTES Procedures

Background: Minimally invasive surgery is rapidly evolving with the promise of new endolumenal and translumenal surgical procedures performed with few or no external incisions. We describe our early human experience with a flexible platform technology that provides stable access and visualization, force transmission, two-handed tissue manipulation and durable tissue approximation. The EndoSurgical Operating System (EOS), (USGI Medical, San Clemente, CA), was used to perform transgastric cholecystectomy, stoma and pouch reduction after gastric bypass, anti-reflux procedures and repair of post gastric bypass gastro-gastric fistulas.
Methods: The EOS is FDA cleared and comprised of a multi-lumen operating platform that can be rigidified and a tissue grasper/approximation device used to create deep tissue approximations or folds secured with suture anchors. The TransPort provides a stable operating platform in a straight or retroflexed position within the stomach or peritoneal space. To treat post Roux-en-Y patients who failed to maintain weight loss a series of folds was placed circumferentially around the stoma to reduce the diameter and randomly into the pouch to reduce the volume. For anti-reflux procedures the TransPort was retroflexed and anchors were used to create a series of folds at the EGJ to build a mechanical reflux barrier. Anchors were also used in the stomach to close gastro-gastric fistulas. In transgastric cholecystectomy procedures the TransPort provided a stable operative field and anchors were used to close the gastrotomy. Video was recorded for each procedure.
Results: A total of 11 patients underwent surgery with the EOS. Stoma diameter and pouch volume were reduced in 4 post gastric bypass patients with weight regain by creating tissue folds using 2–7 anchor pairs. Patients reported early satiety and all have experienced weight loss. Two GERD patients had 3-5 tissue anchors placed at the GEJ and reported reduced reflux symptoms and follow up physiologic data is planned. Gastro-gastric fistula repair was sucessfully performed in 2 patients. Use of the EOS during laparoscopic assisted transgastric cholecystectomy in three patients provided a stable platform for dissection and allowed endolumenal closure of the gastric wall. No significant complications have been encountered to date.
Conclusion: Early clinical use of the EOS in a variety of procedures demonstrated the ability of the system to successfully address some of the many challenges of flexible endolumenal and translumenal surgery.

Session: Podium Presentation

Program Number: S035

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