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Global Regenerative Trade

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THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS:

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APPLICATION DEVICES

The Vivostat® system offers a variety of different disposable application devic­es.

More information about each individual application device is available in the menu below.

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VIVOSTAT® AUTOLOGOUS FIBRIN SEALANT

For many years specialists have prepared autologous fibrin sealant based on thrombin and fibrinogen. The process is complicated, labour intensive and time consuming. With the Vivostat® system this process becomes fast and uncomplicated.

WHAT IS VIVOSTAT FIBRIN SEALANT

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The fully automated Vivostat® system prepares 5-6 ml of autologous fibrin sealant from 120 ml of the patient’s own blood in approx. 24 minutes.

Compared to conventional sealant products, Vivostat® Fibrin Sealant offers a multitude of benefits to both the patient and the surgeon:

  • Excellent safety profile and high biocompatibility

Vivostat® Fibrin Sealant is derived from the patient’s own blood and as such it demonstrates excellent biocompatibility. Unlike conventional products, which are most often based on single donor blood, pooled blood or bovine components (e.g. aprotinin), Vivostat® Fibrin Sealant does not contain any exogenous thrombin or bovine components. The autologous nature of Vivostat® efficiently eliminates the risks of bovine or human borne contaminants. This is the only way to protect the patient against viral diseases not yet identified.
  • Unique and versatile application devices

The wide selection of application devices provide the surgeon with unparalleled freedom in the use of fibrin sealant throughout surgery. The application devices can be used intermittently during the entire surgical procedure without experiencing the blockage that is common in conventional systems. Furthermore, Vivostat® Fibrin Sealant can be applied at very close range allowing for pinpoint application, and rapid polymerisation ensures that the fibrin remains where it is applied.
  • Superior physical properties

Clinical studies and comparative tests have demonstrated that Vivostat® Fibrin Sealant is superior to conventional fibrin sealants on important parameters such as time to haemostasis, elasticity, adhesion to tissue and impact on tissue.

VIVOSTAT® FIBRIN SEALANT OUTPERFORMS CONVENTIONALS PRODUCTS

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The Vivostat® system offers a multitude of benefits to both the patient and the surgeon.

  • As the fibrin sealant is autologous it shows excellent biocompatibility and efficiently eliminates the riscs of viral infection from products based on single donor blood, pooled blood or bovine components. This is the only way to guarantee the patient against viral diseases not yet identified.
  • In order to evaluate the clinically important physical properties of the fibrin sealant, a series of in-vitro rheological and tensile tests and ex-vivo tissue adhesion models were developed.
  • To read about the excellent physical properties of Vivostat® Fibrin Sealant, please select the area of interest in the menu to the left.

UNIQUE TECHNOLOGY ENSURES RAPID POLYMERISATION

An efficient sealant needs to polymerise quickly to build up its internal strength to provide a rapidly effective barrier.

Unlike other sealants, the polymerisation of Vivostat® Fibrin Sealant is activated by a simple pH change, and does not require an enzymic reaction. Polymerisation rates are therefore much faster than conventional fibrinogen/thrombin systems. Activation of the coagulation cascade initiates crosslinking of the fibrin polymer and Vivostat® Fibrin Sealant obtains 80% of its full strength within only 1 minute. The graph shows the polymerisation rate for Vivostat® Fibrin Sealant compared with two conventional sealants. Vivostat Polymerization Comparative kinetics of polymerisation of three fibrin sealants and influence on timing of tissue adhesion · Kjaergard H K et al. · Thrombosis Research 2000; 98: 221-228

Surgical sealants must be very flexible to move with the tissue.

This is especially important with e.g. lungs as the sealant might be applied when the lung is deflated. Unfortunately most compounds have an inverse relationship between strength and elasticity. Comparative tests have shown Vivostat® Fibrin Sealant to be extremely flexible, almost four times as flexible as competing products, without compromising strength. A high level of elasticity is particularly important for surgical procedures involving tissue that undergoes continual expansion or contraction such as the heart and lungs. The graph below shows the elongation at break (mm) for Vivostat® compared with two conventional fibrin sealants after 20 seconds. Comparative kinetics of polymerisation of three fibrin sealants and influence on timing of tissue adhesion · Kjaergard H K et al. · Thrombosis Research 2000; 98: 221-228

STRONG ADHESION TO TISSUES IS CLINICALLY RELEVANT

Many products focus on the tensile strength of the sealant, but neglect the most important parameter of adhesion to tissue.

Providing the internal strength of the sealant and the tissue itself are sufficiently high, it is the sealant:tissue adhesive strength that is the determining factor for tissue:tissue joint failure. A new test method was developed to measure adhesion properties. The test clearly demonstrated the superior performance of Vivostat® Fibrin Sealant compared to conventional products. The graph shows adhesion strength at first break after 20 seconds. Vivostat Tissue Adhesion Comparative kinetics of polymerisation of three fibrin sealants and influence on timing of tissue adhesion · Kjaergard H K et al. · Thrombosis Research 2000; 98: 221-228

VIVOSTAT® – ALWAYS THE SAME HIGH QUALITY

Unlike other patient-derived fibrin sealants, the fibrin concentration in the Vivostat® end-product is independent on the source or the plasma fibrinogen level.
Vivostat Processor 800 The Vivostat® Processor Unit is designed with specially developed sensors and software that carefully detect the individual patient fibrinogen level and automatically adjust the amount of diluting buffer to extract a fibrin sealant with a constant concentration of fibrinogen. In contrast the variation in fibrinogen concentration of conventional patient-derived sealants reflects the normal variation in the plasma fibrinogen level. The constant fibrinogen concentration in Vivostat® Fibrin Sealant guarantees the same excellent physical properties from patient to patient.
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PLATELET RICH FIBRIN®

Platelets and growth factors have been used for many years to help regenerate tissue and stimulate bone formation in e.g. orthopaedic surgery.
Vivostat PRF Set

The thrombocyte solution used in these cases has traditionally been supplied by the blood bank.

Recently, a number of commercial products have entered the market with simpler and smaller devices that are still based on the same centrifugation technology. Most products still require sterile handling and have shortcomings in both the biophysical properties and the delivery system.

Vivostat has solved these problems by leveraging the revolutionary technology used in the Vivostat® system for the preparation and application of autologous fibrin sealant. By combining a fibrin sealant solution with a platelet concentrate, it is possible
to have a carrier, a controlled release and a medium for vascular ingrowth
– all in one product, Vivostat PRF® (Platelet Rich Fibrin).

A REVOLUTION IN TISSUE REGENERATION

  • Growth factors and fibrin are essential components when it comes to regeneration of tissue.

Using the Vivostat® system, you can prepare autologous platelets with multiple growth factors embedded in a fibrin sealant matrix. From 120 ml blood, 5-6 ml of Platelet Rich Fibrin (PRF®) is prepared. By combining a platelet concentrate with a fibrin sealant solution, it is possible to have a carrier, a controlled release and a medium for vascular ingrowth – all in one product, Vivostat PRF®. Compared to conventional PRP products, Vivostat PRF® has a number of advantages.

  • Combining the benefits of platelets and fibrin

With an average 7-fold increase over baseline blood levels, the platelet concentration in Vivostat PRF® exceeds the baseline platelet count of 1 million/μL, which has become a benchmark within platelet therapy. The fibrin matrix ensures a slow release of growth factors over time and effectively protects the growth factors against proteolytic degradation.

  • Superior application performance

The specially designed Vivostat® Spraypen® and the unique combination of platelets and fibrin ensures easy, accurate and efficient application of Vivostat PRF®. Due to instant polymerisation and excellent adhesive properties of the fibrin component, the PRF® solution remains where it is applied – even when applied on vertical or inverted surfaces. As the fibrin component in Vivostat PRF® is based on a fibrin 1 solution, there is no need to use a separate thrombin component.

 

Clinical studies have demonstrated the beneficial effect of combining a platelet concentrate with a high concentration of fibrin.

The Vivostat® system is the first and only system on the market to offer a convenient and fully automated process for the preparation of a platelet rich fibrin (PRF®).

Vivostat PRF® contains a variety of potent growth factors that stimulate fibroblast proliferation and tissue synthesis, e.g. TGF-β1,PDGF, VEGF, FGF-2 etc. Several in-vitro investigations confirm the unique characteristics of Vivostat PRF® and its ability to stimulate cell growth.

The unique combination provides the user with a number of benefits:

Benefits of Vivostat PRF

 
Fibroblasts are fundamentally important in the process of tissue repair.

Apart from producing structural proteins such as collagen, they stimulate both angiogenesis and epithelialisation.

In-vitro studies have proven the positive effect of Vivostat PRF® on fibroblast proliferation. As illustrated, Vivostat PRF® increases the growth of normal human skin fibroblasts compared to control and performs significantly better than PDGF-BB (commercial growth factor).

Data for Fibroblast Cell Count

Bioactivity and stability of endogenous fibrogenic factors in platelet-rich fibrin, Lundquist R. et al., Wound Repair and Regeneration 2008; 16(3): 356-63

 

Collagen deposition is an essential component in the wound healing cascade.

In-vitro studies have illustrated the positive effect of Vivostat PRF® on the ability of fibroblasts to synthesise collagen. Vivostat PRF® performs better than PDGF-AB, the major PDGF isoform in human platelets. The reason for this may be that Vivostat PRF® contains multiple growth factors and not just PDGF-AB.

Data for Type 1 Procollagen

Bioactivity and stability of endogenous fibrogenic factors in platelet-rich fibrin, Lundquist R. et al., Wound Repair and Regeneration 2008; 16(3): 356-63

 

The use of Vivostat PRF® in e.g. wound or orthopaedic procedures is largely dependent on the effect and stability of the PRF®-derived growth factors.

Controlling the release of platelet contents over several days requires not only a delivery media but also protection of the platelets against degradation.

The autologous fibrin matrix in Vivostat PRF® has shown to protect endogenous growth factors against proteolytic degradation and thereby preserve their biological activity.

Data on Growth Factor Levels of PDGF-ABData on Growth Factor Levels of PDGF-AB

Bioactivity and stability of endogenous fibrogenic factors in platelet-rich fibrin, Lundquist R. et al., Wound Repair and Regeneration 2008; 16(3): 356-63

Vivostat PRF® delivers a concentrate of growth factors embedded in a fibrin matrix.

Following application of the Vivostat PRF® solution, the fibrin matrix will naturally be broken down by fibrinolytic processes (fibrinolysis), and during this process the growth factors contained in the platelets are gradually released to the treatment site over a period of 4 days or more. In effect, the fibrin matrix is a delivery media that slowly releases growth factors over time.