A Novel 4 × 2 Stapling System for Sleeve Gastrectomy: Enhanced Mechanical Integrity and Hemostatic Performance in a Porcine Model

Abstract

Background:

Sleeve gastrectomy has become the most commonly performed bariatric procedure worldwide, yet staple line complications including bleeding and leakage remain significant concerns. The EnDrive Zero stapler features an innovative 4 × 2 configuration with B-Duo reinforced design, theoretically offering superior mechanical integrity and enhanced hemostasis compared with conventional staplers.

Methods:

Fourteen pigs underwent laparoscopic gastric stapling using either the EnDrive Zero test device (n = 6) or a conventional control stapler (n = 6). Gastric stapling was performed along the greater curvature under acute hypertension induced by epinephrine (8 μg/kg) to simulate demanding clinical conditions. Primary outcomes included intraoperative hemostasis scores, staple line integrity, and ex vivo burst pressure testing. Animals were followed for 28 days with comprehensive clinical, hematological, and histopathological evaluation.

Results:

Both devices achieved excellent hemostatic control with no significant differences in bleeding scores (stomach vessels: 2.3 ± 0.8 versus 1.7 ± 0.8, P = .183; gastric tissue: 1.3 ± 0.5 versus 1.1 ± 0.4, P = .552). All animals survived 28 days without adverse events, demonstrating 100% anastomotic success and complete healing. However, ex vivo burst pressure testing revealed significantly superior mechanical integrity for the test device (251.3 ± 15.6 mmHg versus 226.3 ± 16.3 mmHg, P = .013), representing an 11% improvement. Histopathological examination showed minimal tissue reactivity in both groups with no significant differences.

Conclusion:

The EnDrive Zero 4 × 2 stapler demonstrated hemostatic performance equivalent to conventional staplers while providing significantly superior mechanical strength in gastric stapling. This enhanced burst pressure, combined with the theoretical hemostatic advantages of four-row stapling, may offer additional safety margins against both bleeding and leak complications in sleeve gastrectomy, warranting clinical investigation in bariatric surgery.