Device Dossier
MateRegen Gel - Wound hydrogel dressing, non-antimicrobial
Device Dossier for MateRegen Gel - Wound hydrogel dressing, non-antimicrobial (Wound hydrogel dressing, non-antimicrobial, Class III, sponsor…
- GMDN category: Wound hydrogel dressing, non-antimicrobial
- Sponsor: Endotherapeutics
Intended purpose
Absorbable Adhesion Barrier Gel is indicated for the prevention or reduction of post-surgical adhesion formation in the abdomino-pelvic area after laparoscopic/hysteroscopic and open gynaecological surgical procedures.
Functional description
MateRegen Gel is a sterile, transparent and highly viscous gel. The active component is cross-linked molecules of hyaluronan (HA) from non-animal source. The cross-linking process makes HA more viscous and persisting longer in vivo. The gel is applied to the surgical site where it adheres to the tissue surface and creates an anti-adhesion barrier, keeping adjacent tissues separated following surgery. The gel is intended to be absorbed within 30 days of application.