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).…
- GMDN category: Synthetic peptide haemostatic agent
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.