The Dynamic Regenerative Scaffold Stenting & Shielding Hernia System for Dissection-Free, Atraumatic Hernioplasty. Results of an Experimental Animal Study

Conventional hernia repair using static flat meshes is often associated with complications casused by extensive dissection, implant fixation, and poor biological response. The Stenting & Shielding (S&S) Hernia System offers a novel solution designed for dissection-free, fixation-free hernia repair. The S&S Hernia System has been evaluated in a porcine model, focusing on procedural simplicity, device retention and regenerative properties. The experimental study involved 10 pigs, each implanted with two S&S devices. Follow-up assessments included ultrasound, laparoscopic examinations, and histological analyses over a period ranging from 4 weeks to 8 months post-implantation. The S&S Hernia System, made from medical-grade polypropylene-based thermoplastic elastomer (TPE), features a rayed 3D scaffold and an oval shield connected by a mast. Delivered and positioned intraabdominally without dissection, the device transforms into a self-retaining scaffold to obliterate the hernia defect. Primary outcomes included ease of delivery, visceral adhesion formation, and device retention, ensuring no dislocation. Secondary outcomes evaluated histological evidence of tissue regeneration, including the development of connective tissue, muscles, vessels, and nerves within the scaffold. Immunohistochemistry was used to detect tissue growth factors promoting regeneration of the abdominal wall's typical components. All 20 implanted devices remained securely in place without dislocation. Transient adhesion bands were observed in two shields at 1 month but resolved by 3 months. No visceral adhesions were detected at the time of animal sacrifice. Histological analyses demonstrated tissue regeneration within the scaffold, while immunohistochemistry confirmed the presence of growth factors supporting regeneration. Overall, the S&S Hernia System showed promising results in a porcine model, with no dislocation and evident regenerative potential. Its rapid, dissection-free delivery and compliance with abdominal wall dynamics simplify the procedure while minimizing adhesions. These findings warrant further clinical investigation to validate its application in human patients.