Safety and performance evaluation of the automated helical suturing system as compared with the manual suturing platform in endoscopic sleeve gastroplasty in a porcine model.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) and gastric volume reduction techniques have been shown to achieve significant weight loss and improvement in comorbid conditions. The objective of this study was to assess the safety, applicability, and usability of a novel fully automated, operator-independent endoscopic suturing system for minimally invasive treatment of obesity in pigs.

METHODS

Endoscopic procedures were performed in 6 domestic swine that were subjected to an internal gastric segmentation within the stomach using the EndoZip Implant (Nitinotes Ltd, Caesarea, Israel) followed by a similar endoscopic suturing system, the OverStitch ESG Implant (Apollo Endosurgery, Austin, Tex, USA) as the reference/control item. The EndoZip and OverStitch sutures were applied in each animal at 2 adjacent sites in the stomach. After each procedure, a usability questionnaire was filled out by the physician. Three animals (group 1) were monitored for a period of 7 days and 3 animals (group 2) for a period of 28 days after the procedures. On termination, segmentation sites were inspected by gross pathology examination.

RESULTS

No clinically significant abnormal clinical signs were observed during the follow-up period. Blood tests showed normal levels, and abnormal findings were observed during gross pathology examination but were not clinically significant. The histopathologic evaluation showed the tissue reaction was very similar histologically in both the ESG and automated helical suturing system samples and within expected ranges for a foreign body reaction. All 6 automated helical suturing system suture patterns were identical, demonstrating consistent tunnel creation.

CONCLUSIONS

Under the conditions of this study, the automated helical suturing system was safe in this preclinical study, and further studies are required. The tissue reaction was moderate and focal and within expected ranges for a foreign body reaction (implantation of a device) in both the EndoZip and OverStitch samples.