PuraStat

Providing Clear Control

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 or endoscopic procedure, when haemostasis by ligation or standard means is insufficient or impractical¹:

• 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 and rectum

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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 swell¹

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.

1. Data on file (Swell Report 2018, Eun Seok Gil 12/06/2018)

2. PuraStat Instructions for Use IFU-007 / IFU-011 Rev 2

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PuraStat = No Assembly or Preparation

PuraStat is delivered in a prefilled syringe, just connect the applicator using the luer and the product is ready to use.

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

1. Morshuis M, Final Clinical Study Report: A Single-Centre, Single Arm Post-Market Clinical Follow-Up to Confirm the Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding After Left Ventricular Assist Device (LVAD) Implantation

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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.

1. Masuhara H. et al. Novel Infectious Agent-Free Hemostatic Material (TDM-621) in Cardiovascular Surgery Ann Thorac Cardiovasc Surg. 2012;18(5):444-51

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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.¹

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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.

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PuraStat is Transparent

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

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PuraStat Will Not Migrate¹

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.

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.

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.

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