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PuraStat®

Providing Clear Control

PuraStat<sup>®</sup>

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

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Technology

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.

the peptide in PuraStat the peptide in PuraStat

Product Advantages

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.

Mammalian ECM

a

Mammalian ECM1

X15,0001Mm

Mammalian ECM

1

b

PuraStat Scaffold1

X15,0001Mm
1
Dhwani J. ,Rajesh V. A Review on Extracellular Matrix Mimicking Strategies for an Artificial Stem Cell Niche. Polymer Reviews. 2015, 55:4, 561-595, DOI:10.1080/15583724.2015.1040552

Free From Glutaraldehyde1

PuraStat® contains no glutaraldehyde.

This is what the Centre for Disease Control & Prevention (CDC) says about the effects of exposure to glutaraldehyde2: workers can be exposed to glutaraldehyde through inhalation or skin contact. Health effects that may occur as a result of exposure to glutaraldehyde include but are not limited to the following:

  • Throat and lung irritation
  • Asthma and difficulty breathing
  • Contact and/or allergic dermatitis
  • Nasal irritation
  • Sneezing
  • Wheezing
  • Burning eyes and conjunctivitis
1
PuraStat® Instructions for Use, 3-D Matrix Europe SAS, IFU-002 rev 2.2
2
https://www.cdc.gov/niosh/topics/glutaraldehyde/default.html last accessed 05/12/2017

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, 3-D Matrix Europe SAS, IFU-002 Rev 2.2

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
PuraStat® Instructions for Use, 3-D Matrix Europe SAS, IFU-002 Rev 2.2

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

PuraStat® is 100% Synthetic

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
PuraStat® Instructions for Use, 3-D Matrix Europe SAS, IFU-002 Rev 2.2

PuraStat® is Resorbed in 30 Days1

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
A conditionally essential amino acid, it plays an important role in cell division, the healing of wounds, removing ammonia from the body, immune funciton, and the replease of hormones
Alanine
Ala
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
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
1
PuraStat® Instructions for Use, 3-D Matrix Europe SAS, IFU-002 Rev 2.2

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<sup>®</sup> is Suturable & Clipable

PuraStat® is Transparent

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

PuraStat<sup>®</sup> is Transparent
1
PuraStat® Instructions for Use, 3-D Matrix Europe SAS, IFU-002 Rev 2.2

PuraStat® Will Not Migrate1

PuraStat® is naturally viscous, this means it will not run or fall away from the application site. 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<sup>®</sup> Will Not Migrate<sup>1</sup>
1
PuraStat® Biologic Safety Report – Current Version

Mode of Action

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.
thumbnail for applying purastat is simple video

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.

Products from 3-D Matrix

Applicators

Whereas PuraStat® is a slightly viscous solution, it fits requirements for a haemostat in endoscopy and in laporoscopy, including robotic/ robot assisted procedures.

PuraStat®

PuraStat is a synthetic haemostatic material in the form of a prefilled syringe, filled with a clear, aqueous peptide solution.Contact between the product and liquids such as blood leads to the formation of fibres in the aqueous solution, yielding a peptide hydrogel. The hydrogel quickly coats the point of bleeding and, by physically closing the superficial part of the broken blood vessel, causes blood coagulation in the deeper part of the vascular wall, resulting in haemostasis.
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