PuraStat™

Providing Clear Control

Purastat

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 and surrounding tissues of solid organs;
  • Oozing from vascular anastomoses to native or artificial vessels, on the surface of blood vessels and surrounding tissues;
  • Bleeding from small vessels and oozing from capillaries of the GI tract and surrounding tissues:
    • Reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon.

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.

PuraStat™ does not swell

In internal testing PuraStat™ does not swell after implantation or during the resorption process. This is because unlike other hydrogels which are designed to absorb water as part of their breakdown cycle, PuraStat™ is broken down by enzymatic action.

As PuraStat™ doesn’t swell it will not cause compression of underlying tissues of structures, or prevent that natural physiologic dilatation of vessels.

 

No Assembly or Preparation

PuraStat™ is delivered in a prefilled syringe, just attach the applicator using the luer and the product is available for use.

PuraStat™ has been demonstrated to achieve complete haemostasis in less than 15 seconds.1

 

Revolutionary Bleeding Control

The trigger for the peptides in PuraStat™ to begin self assembly is a change in ionic charge. PuraStat™ is acidic so when in contact with more alkaline liquids the reduction in ionic charge causes the rapid self assembly of β-sheets. The β-sheets then transition to form a complex network of fibres with a diameter of around 10–20 nm and pores with a diameter of about 50–200nm that resembles the mesh structure of natural collagen1. The formation of this complex fibre network rapidly seals the bleeding point leading to haemostasis.

 

PuraStat™ is Resorbed in 30 Days

PuraStat™ is broken down by the actions of enzymes which break down the peptide scaffold into the constituent amino acids over approximately 30 days.1 The amino acids are metabolised by the body or excreted if they are surplus to requirements.

Breakdown Component

Arginine
Arg
Arginine A conditionally essential amino acid, it plays an important role in cell division, the healing of wounds, removing ammonia from the body, immune function, and the release of hormones
Alanine
Ala
Alanine A nonessential amino acid, meaning it can be manuratured by the human body, hence need not be obtained directly through diet. Alanine is found in a wide variety of foods
Asparatic Acid
Asp
Asparatic Acid An acidic amino acid that is a constituent of most proteins and also occurs in sugar cane. It is important in the metabolism of nitrogen in animals and also acts as a neurotransmitter

 

PuraStat™ is 100% Synthetic

PuraStat™ contains no glutaraldehyde.

The peptides are made from chemically synthesized amino acids to guarantee the final product is contamination free. The amino acids are bonded together in a specific sequence at a 2.5% concentration in aqueous solution to make PuraStat™.

 

PuraStat™ is Suturable & Clipable

Because PuraStat™ is a liquid hydrogel, it is largely composed of water and remains completely flexible once applied. Because it does not harden or cure it remains soft and can easily be sutured through should the need arise.

This also means that you can place surgical or endoscopic clips directly through a layer of PuraStat™, this is very helpful if using PuraStat™ to clearly identify bleeding points when bleeding is more profuse or persistent.

 

PuraStat™ is Transparent

This image demonstrates the transparency of PuraStat™ once applied clear visualisation of the underlying tissue is maintained.

 

PuraStat™ Will Not Migrate

PuraStat™ is naturally viscous. When in contact with blood the change in pH causes the self assembly of PuraStat™ to occur rapidly at the interface between it and the bleeding point, gaining further integral strength as the reaction occurs. Any PuraStat™ not incorporated in the final clot will separate and may be left in situ.

Documentation

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