Revolutionary Bleeding Control
The trigger for the peptides in PuraShield to begin self assembly is a change in ionic charge. PuraShield 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
PuraShield mimics extra cellular matrix
The peptides in PuraShield 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 PuraShield 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.
a Mammalian ECM1
X15,000
1Mm
b PuraShield Scaffold1
X15,000
1Mm
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
PuraShield 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 PuraShield. 1
This means that PuraShield is well accepted by the body.
1. PuraShield IFU-015 Rev 2
PuraShield does not swell1
In internal testing our PuraShield does not swell after implantation or during the resorption process, as it is made up of the RADA16 peptide. This is because unlike other hydrogels which are designed to absorb water as part of their breakdown cycle, PuraShield is broken down by enzymatic action.
As PuraShield doesn’t swell, it will not cause compression of underlying tissues, or prevent the natural physiologic dilatation of vessels.
1. Data on file (Swell Report 2018, Eun Seok Gil 12/06/2018)
2. PuraShield IFU-015 Rev2
Ready to use
Surgeons may have to wait for haemostats to be assembled or prepared during a procedure, whilst having to manage the bleeding area. This can be time critical and costly as the procedure is prolonged.
PuraShield is delivered in a prefilled syringe, just connect the applicator using the luer-lock and the product is ready to use. It does not require any preparation before or during surgery, allowing surgeons to quickly manage bleeding and continue with the procedure.
PuraShield* 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
PuraShield is Resorbed in 30 Days1
As PuraShield is made up amino acids, it is fully absorbed by the body and does not need to be removed. It 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.
Should PuraShield need to be reapplied, the existing hydrogel can either be easily washed away if you choose, or another layer can be simply applied on top of the existing layer.
1. PuraShield IFU-015 Rev 2
PuraShield is Transparent
This image demonstrates the transparency of PuraShield. Once applied, clear visualisation of the underlying tissue is maintained, allowing surgeons to easily observe the bleeding point and continue with the procedure once haemostasis has been achieved.
PuraShield is Suturable & Clipable
As PuraShield is a liquid hydrogel, it is largely composed of water and remains completely flexible once applied, making it suitable for a variety of situations.
PuraShield does not harden or cure, it remains soft, meaning it can be easily be sutured through should the need arise.
This also means that you can place surgical or endoscopic clips directly through a layer of PuraShield, this is very helpful if using PuraShield to clearly identify bleeding points when bleeding is more profuse or persistent.
PuraShield Will Not Migrate1
PuraShield is naturally viscous, this means it is flexible enough to flow easily into small and uneven spaces. When in contact with blood the change in pH causes the self assembly of PuraShield to occur rapidly at the interface between it and the bleeding point, gaining further integral strength as the reaction occurs. Any PuraShield not incorporated in the final clot will separate and may be left in situ.
The flexibility of this hydrogel also ensures that it does not clog in the syringe, allowing it to be easily used multiple times throughout a procedure and reducing the need to prepare a new haemostat, providing surgeons with extra relief during time critical procedures.
1. PuraShield Biologic Safety Report – Current Version
PuraShield 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 PuraShield is simple
PuraShield 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 PuraShield is just as easy, simply deploy PuraShield 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 PuraShield to the haemorrhagic site.
- The nozzle should be as close as possible to the bleeding point.
- Do not disturb the self-assembled PuraShield gel until sufficient time has been allowed for haemostasis to occur.
- If necessary, repeat the application of PuraShield several times until haemostasis is achieved.
- After haemostasis is confirmed, excess PuraShield may be left in place.
Supported by data
We work closely with clinicians to continuously develop the potential of PuraShield in the ENT field
