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.
Free From Glutaraldehyde1
Unlike BioGlue®, PuraStat® contains no glutaraldehyde. Polymerized BioGlue® releases amounts of glutaraldehyde that are capable of inducing cytotoxic effects both in vitro and in vivo2
This is what the Centre for Disease Control & Prevention (CDC) says about the effects of exposure to glutaraldehyde3: 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
- Burning eyes and conjunctivitis
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.
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. The chart below depicts the relative time to functional use (this includes the preparation time of the product according to manufacturers recommendations/preparation instructions and associated waiting periods/time to gelation) of commonly used products in the Operating Room compared to PuraStat®.
PuraStat® has been demonstrated to achieve complete haemostasis in less than 15 seconds.1
Chart depicting the relative time to functional use, this includes the preparation time (where available or a practice assessment of preparation time) and associated waiting periods/time according to manufacturers IFUs
1, 2, 3, 4, 5, 6, 7
*Surgiflo with Thrombin
Rapid Self Assembly = Rapid Hemostasis1, 2
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 collagen3. The formation of this complex fibre network rapidly seals the bleeding point leading to haemostasis.
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®.
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.
|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|
|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|
|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 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 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.
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.
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 rev2.1 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.