Endoform Reconstructive Template - PLGA

Endoform™ Reconstructive Template – PLGA is a surgical mesh made of multiple layers of sheep-derived extracellular matrix reinforced with poly(lactic-co-glycolic) acid (PLGA). It is intended to reinforce and repair soft tissue where weakness exists, particularly for hernia and abdominal wall defect repair. The device comes in various shapes, sizes, and thicknesses up to 400 cm² and is sterilized using ethylene oxide.

The primary difference from the predicate device is the polymeric reinforcement material: the subject device uses PLGA, while the predicate uses polyglycolic acid (PGA). Both use ovine-derived extracellular matrix layers sewn together with polymeric suture, identical maximum size, identical packaging, identical endotoxin specifications (<20 EU/device), and identical sterilization method (ethylene oxide at 10⁻⁶ SAL).

Biocompatibility assessment and testing were performed in accordance with FDA Guidance on Use of International Standard ISO 10993-1 (Biological evaluation of medical devices – Part 1). Non-clinical testing included mechanical strength, suture retention, elastic modulus, collagen differential scanning calorimetry, endotoxin, bioburden, and compliance testing.

The subject device maintains the same fundamental technological characteristics, material types, device specifications, sterilization method, and intended use as the predicate. The substitution of PLGA for PGA as the polymeric reinforcement is a minor material change that does not introduce new questions of safety or effectiveness, as supported by comprehensive non-clinical testing demonstrating equivalent mechanical and biocompatibility performance. Both devices are composed of the same animal-derived matrix and serve identical surgical indications.