PuraStat®

PuraStat is a synthetic haemostatic material in the form of a prefilled syringe.

PuraStat is indicated for haemostasis in the following situations encountered during surgery, when haemostasis by ligation or standard means is insufficient or impractical:

  • Bleeding from small blood vessels and oozing from capillaries of the parenchyma of solid organs
  • Oozing from vascular anastomoses
  • Bleeding from small vessels and oozing from capillaries of the GI tract
    • Reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon
A product by 3-D Matrix
Description

PuraStat® Technology

The matrix is formed from synthetic peptides which are composed of three naturally occurring amino acids in a sequence which is repeated 4 times. The peptides self-assemble to form a 3 dimensional matrix upon a change in pH2 caused by exposure to an ionic solution such as blood, peritoneal fluid or other bodily secretions.

PuraStat® mimics extra cellular matrix

The peptides in PuraStat® are synthetized in a specific sequence which provide the molecule with shape memory to enable them to self assemble into a scaffold which mimics human extra cellular matrix (ECM).

Based on results of scanning electron microscopy, the structure of PuraStat® self-assembling peptide hydrogel is understood to be a network of fibres with a diameter of around 10–20 nm and pores with a diameter of about 50–200 nm that resembles the mesh structure of natural collagen.

Applying PuraStat® is simple

PuraStat® is a haemostat existing of a nanofiber network structure that requires no preparation. This means it is ready to apply straight from packet to patient.
To apply PuraStat® is just as easy, simply deploy PuraStat® at the base of the lesion and wait, following the instructions below:

  • Remove as much blood as possible from haemorrhagic site.
  • Apply an adequate quantity of PuraStat to the haemorrhagic site.
  • The nozzle should be as close as possible to the bleeding point.
  • Do not disturb the self-assembled PuraStat gel until sufficient time has been allowed for haemostasis to occur.
  • If necessary, repeat the application of PuraStat several times until haemostasis is achieved.
  • After haemostasis is confirmed, excess PuraStat may be left in place.
PuraStat proves to reduce the rate of delayed bleeding following colonic ESD*

PuraStat® is the first haemostatic agent that is indicated for the reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon.

*Important Note: The IFU-002 rev2.2 is currently approved only in Europe. The current IFU outside of Europe depends on the registration status. The approved indication can differ in your country, please contact 3-D Matrix if you need any additional information on device indication.