Device Dossier

Coseal Surgical Sealant - Multi-purpose surgical adhesive

Device Dossier for Coseal Surgical Sealant - Multi-purpose surgical adhesive (Multi-purpose surgical adhesive, Class III, sponsor Baxter Healthcare).…

Intended purpose

Coseal is indicated for Sealing suture lines along arterial and venous reconstructions; Enforcement of suture and staple lines in lung resection procedures; Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extent of post-surgical adhesion formation; Patients undergoing laparotomic or laparoscopic gynaecological surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post-surgical adhesion formation.

Functional description

Coseal is a synthetic hydrogel(PEG)designed to act as a sealant around a sutured site. It is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. The mixed PEG's and solutions form a hydrogel that adheres to tissue, synthetic graft material.

TGA Public Summary