Device Dossier

NxPura - Synthetic peptide haemostatic agent

Device Dossier for NxPura - Synthetic peptide haemostatic agent (Synthetic peptide haemostatic agent, Class III, sponsor 3-D Matrix Medical Technology).…

Intended purpose

Intended to be used for haemostasis during surgery or endoscopic procedure when control of mild, moderate and severe bleeding by ligation or standard means is insufficient or impractical.

Functional description

Contact between the product and liquids with physiological pH, such as blood, neutralizes the acidic peptide solution. As a result, the β-structured peptide molecules readily self-assemble into a three-dimensional network of fibres in the aqueous solution, forming a peptide hydrogel. The hydrogel quickly coats the bleeding point and acts as a mechanical barrier over the superficial part of the damaged blood vessel, allowing coagulation in the deeper vascular wall and resulting in haemostasis.

TGA Public Summary