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Global Regenerative Trade

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SAFE, VERSATILE AND EASY TO USE

The world’s only system for on-site preparation of autologous fibrin sealant and Platelet Rich Fibrin (PRF®). It provides a range of safe, versatile and user-friendly products for a great number of clinical applications.

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.

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INFORMATION

about the product

 

AUTOLOGOUS BIOLOGICAL MATERIAL

The uniqueness of the Vivostat®_ preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

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MEDICAL PROFESSIONALS

Vivostat® has a product that can help overcome challenges with:  HAEMOSTASIS, SEALING, GLUING or REGENERATION OF TISSUE.
 
 
Cells and nerves

THREE COMPONENTS ARE ENOUGH

The fully automated Vivostat® system consists of three components: Processor Unit, Applicator Unit, The Disposable Set
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A REVOLUTION IN FIBRIN SEALANT TECHNOLOGY
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. 
 
 
 

PRODUCTS

Vivostat Product

THE VIVOSTAT® SYSTEM

Vivostat Application Devices

APPLICATION DEVICES

Vivostat Fibrin Set

Vivostat® FIBRIN SEALANT

Vivostat PRF Set

Vivostat PRF®

MEDICAL PROFESSIONALS

The Vivostat® product line can be used in a wide range of surgical procedures and environments. In the left hand menu you will find the most common areas of use for Vivostat® 
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BURNS SURGERY

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NEURO SURGERY

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MISSION AND VISION

MISSION

Support soft tissue healing following medical treatment by enhancing the body’s own capabilities

VISION

Vivostat wants to be a preferred supplier of solutions offering enhanced healing through autologous blood derived products and improved outcomes through combination treatments 
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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:

  • The Processor Unit is a non-sterile, reusable, fully automated device that controls the biochemical process.
  • The Processor Unit is used to process the patient’s blood and prepare the Vivostat® Fibrin Sealant or Vivostat PRF® solution.
Vivostat Processor Product
  • The Processor Unit is operated by a single button and a display keeps the nurse informed of the remaining process time and status at all times. No specific installation is required and the large wheelbase makes moving it easy.
  • The Processor Unit can be located in any room or corridor in the operating department. It is most often placed centrally between the operating theatres. This way one Processor Unit can supply a number of operating theatres.
  • In approx.  25 min a concentrated fibrin sealant or PRF® solution is prepared from the patient’s whole blood.
  • The Applicator Unit is a non-sterile, reusable, fully automated device that controls the delivery of the Vivostat® Fibrin Sealant or Vivostat PRF®.
Vivostat Processor Product
  • The large display and integrated microprocessor automatically primes the Spraypen® and informs the surgeon of the remaining volume of fibrin sealant/PRF® throughout the entire process.
  • Different spray modes can be selected depending on the actual procedure or area to be covered. Like the Processor Unit it has a large wheelbase and can easily be moved if required.
  • The disposable set comprises of two parts: A Preparation Kit used to prepare the fibrin sealant or PRF® solution before surgery, and an Application Kit used to activate and apply the fibrin sealant/PRF® solution.

 

  • Preparation Kit
    The Preparation Kit contains the specially designed Preparation Unit – a sterile disposable device in which the patient’s blood is collected, the biochemical process carried out, and the fibrin sealant or PRF® solution harvested.

 

  • The Application Kit
    The Application Kit contains the Spraypen®1 and all other items required to prepare the system for the delivery of the fibrin sealant or PRF® solution. The Spraypen® is a sterile, disposable, hand held device which delivers the fibrin sealant or PRF® solution to the tissue. The revolutionary and patented design offers the surgeon unparalleled freedom in controlling the application unlike any other product on the market today.

 

1Besides the Spraypen®, the Vivostat® system offers different types of applicators, e.g. the Endoscopic Applicator. For a full list of application devices click here

1-2-3 Spray

Three easy steps to prepare Vivostat® Fibrin Sealant or Vivostat PRF®

1. Draw blood from the Patient

Fibrin Prep With Blood Inside

At the time of surgery or up to 24 hours before1, citrate (supplied with the kit) is added to the Preparation Unit. 120 ml of the patient’s own blood is then drawn into the same unit.

2. Process the patient’s blood

Vivostat Processor 800

The Preparation Unit is placed in the Processor Unit. At the touch of a button the process starts; after approx. 25 minutes, an autologous fibrin or PRF® solution is ready for use. No thrombin or bovine components are added to the blood at any time.

3. Load the Applicator Unit and spray

Vivostat Display Applicator

The Fibrin or PRF® solution is easily loaded into the Applicator Unit and applied to the surgical site using one of the unique application devices (e.g. the Spraypen). 1This depends on the type of kit being used. Always consult the “Instructions for Use” supplied with the kit to determine the correct preparation.

The following video illustrates how to prepare and apply autologous fibrin sealant.

Presentation DVD from Vivostat A/S on Vimeo.

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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.

 

The outstanding design of both the Applicator Unit and the Vivostat® Spraypen provides the surgeon with up to 4 minutes of constant spraying from only 5 ml of Vivostat® Fibrin Sealant or Vivostat PRF®.

Vivostat Pen

Unlike conventional application systems, the Vivostat® Spraypen gives the surgeon freedom to place the solution very accurately on the target site instead of the surrounding tissue. This is especially important in pin point applications, micro anastomosis and difficult to reach areas.

The great degree of accuracy enables the surgeon to make better use of the fibrin sealant/PRF® solution and improves efficiency. 

 

Together with leading surgeons, the Concorde Spraypen® has been developed as a special application device for surgical procedures where the Vivostat® solution is needed in difficult to reach areas.

Today the Concorde Spraypen® is used in a wide range of surgical procedures. With the carefully optimized angle on the spraytip, surgeons find the Concorde Spraypen® very convenient for the application of e.g.  fibrin sealant on anastomosis on the backside of the heart, sealing of the marmary bed and some types of abdominal surgery in difficult to reach organs. The Concorde Spraypen® utilizes the same unique spray nozzle as the original Spraypen®, allowing the surgeon to apply the Vivostat® solution in a precise and targeted manner throughout the entire procedure without experiencing blockage.

 

Using the specially designed Vivostat® Endoscopic Application System, Vivostat® Fibrin Sealant/PRF® can be used in various types of minimal invasive surgery.

 

Endoscopic Handle

The single-use endoscopic application catheter is easily loaded into the endoscopic applicator handle (reusable) and the handle is inserted via a 5 mm trocar.

When using the Endoscopic Applicator, the Vivostat® solution is applied through the same unique nozzle that is also used with the Spraypen®. This allows the surgeon to apply the Vivostat® solution in a precise and targeted manner throughout the entire procedure without experiencing blockage. Due to the preformed nozzle, the spray tip can easily be manipulated in many directions giving the surgeon unparalleled freedom in control of application, unobtainable with conventional application systems.

When using the Vivostat® Endoscopic Applicator the application of fibrin or PRF® is activated by a foot switch.

The Vivostat® Endoscopic Kit-Co-delivery looks and performs similar to the Endoscopic Kit (it also requires the Vivostat® Endoscopic handle).

 

However, there is an additional channel in the catheter that allows the surgeon to co-deliver a substance together with the Vivostat Fibrin Sealant or Patelet Rich Fibrin (PRF®).

With the Endoscopic Kit – Co-delivery the surgeon is able to topically co-apply the substance, for slow release from the Vivostat Fibrin Sealant or PRF® solutions. Doing this endoscopically means less stress on the patient.

 

 

The Vivostat® Endoscopic Straight  is developed for the application of Vivostat® in deep wounds and fistulas. In combination with specially designed spray modes for the Applicator Unit, the flexible catheter completely fills wounds and fistulas with Vivostat® without leaving any cavities.

 

When using The Vivostat® Endoscopic Straight the fibrin sealant or PRF® solution is applied through the same unique nozzle that is also used with the Vivostat® Spraypen®. This allows the surgeon to apply the Vivostat® solution in a precise and targeted manner throughout the entire procedure without experiencing blockage. When using the Vivostat® Endoscopic Straight the application of fibrin or PRF® is activated by a foot switch.

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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.

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IN ABDOMINAL SURGERY

Abdominal surgery covers a vast number of procedures. Many of these are performed with minimally invasive techniques, and the ability to use the Vivostat® Endoscopic Applicator has proven very useful. Vivostat® is being used in a wide range of these procedures – such as:

 

 

 

→LIVER PART RESECTION
→PANCREAS
→SPLEEN
→HERNIA MESH FIXATION
→FISTULA

 

 

Some general challenges that apply to most abdominal procedures are listed below:

  • Haemostasis
  • Sealing of the treatment area
  • Gluing e.g. hernia mesh fixation
  • Regeneration of tissue

Vivostat offers the surgeon a choice of two products which can help overcome these challenges. If haemostasis, sealing or gluing are the primary challenges, Vivostat® Fibrin Sealant is an excellent choice. If it is a combination of haemostasis, sealing, gluing and regeneration of tissue, Vivostat PRF® is the ideal product.

Vivostat Autologous Fibrin Sealant is an autologous sealant that outperforms other fibrin sealants on parameters such as polymerisation, elasticity, adhesion and impact on tissue.

Vivostat PRF® is a second generation platelet enriched product acting both as a haemostat/sealant while at the same time supporting tissue regeneration and wound healing.

SUPPORTING EVIDENCE IN ABDOMINAL SURGERY

 

Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair
I.H.J.T. de Hingh, S.W. Nienhuijs, E.P. Overdevest, K. Scheele, P.A.M. Everts
European Surgical Research 2009; 43: 306–309

Experimental study of a novel fibrin sealant for achieving haemostasis following partial hepatectomy
B.R. Davidson, S. Burnett, M.S. Javed, A. Seifalian, D. Moore, N. Doctor
British Journal of Surgery 2000; 87: 790-795

Laparoskopische Eingriffe an der Milz
S. Uranüs, J. Pfeifer, O. Alimoglu, T. Hzmen
Chirurgische Gastro enterologie 2004; 20 (2):35–41

Autologous fibrin sealant (Vivostat) for mesh fixation in laparoscopic transabdominal preperitoneal hernia repair
Schmidt SC, Langrehr JM
Endoscopy 2006; 38:841 – 844

Laparoscopy in Abdominal Trauma
S. Uranüs, K. Dorr
European Journal of Trauma and Emergency Surgery 2010; 36: 19–24

Platelet-Rich Fibrin Sealant as a Treatment for Complex Perianal Fistulas: A Multicentre Study
F.J Pérez Lara et. al.
The Society for Surgery of the Alimentary Tract. 2014 

Using autologous platelet-rich plasma for the treatment of complex fistulas
Moreno-Serrano et. al.
Revista Española de Enfermedades Digestivas 2016; Vol 108, 123-128

 

ABDOMINAL VIDEO

These videos illustrate how Vivostat® is used in different abdominal procedures.

 

Liver surgery – Anatomical left lateral sectoriectomy from Vivostat A/S on Vimeo.

Distal Pancreatectomy from Vivostat A/S on Vimeo.

Laparoscopic hernia repair from Vivostat A/S on Vimeo.

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VIVOSTAT PRF® IN BURNS

For decades fibrin sealant has been used for burns as a scaffold for re-epithelialization. Vivostat PRF® provides this scaffold and combines it with a high concentration of platelets relevant for tissue regeneration. 
Regenerative Medicine Skin Procedure

The high concentration of fibrin found in Vivostat PRF®, furthermore, acts as a glue enabling the surgeon to use Vivostat PRF® for graft fixations. Using Vivostat PRF® to fixate the graft allows the surgeon to use less staples or none at all depending on the location of the burn. The fibrin also acts as a haemostatic reducing the risk of haematoma formation, which may cause graft loss. Any remaining Vivostat PRF® can be applied to the graft harvest site to speed up tissue regeneration and reduce pain for the patient.

Vivostat® Applicator Kits

Skin cells/stem cells are expensive and it is crucial that they do not run off the burn or stick to the dressing. By using the Vivostat® system it is possible to glue the skin cells/stem cells to the burn with the Vivostat PRF® solution.

PRF® solution ensures that the cells stay where they are applied as the fibrin found in Vivostat PRF® polymerizes upon application. 

 

SUPPORTING EVIDENCE IN BURNS

 

Evaluation of platelet-rich fibrin in deep dermal burn: a case study 
Fontein D., Burger M., Mannil L., Giovanoli P., Plock J.
Abstract presented at 53. Congress of Swiss Plastic Surgery

Succesful application of keratinocyte suspension usin autologous fibrin spray
Johnstone P., Kwei J.S., Filobbos G., Lewis D., Jeffery S.
Journal of the International Society for Burn Injuries

 

BURNS VIDEO

This video shows Vivostat PRF® utilized in a burns surgery on the back. In this video Vivostat® is Co-Delivered with keratinocytes.

 

Burns surgery from Vivostat A/S on Vimeo.

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IN CARDIAC SURGERY

For more than a decade, Vivostat® has been used in cardiac surgery. Cardiac surgeons find Vivostat® most useful for the following surgical procedures:

 

 

  • Coronary artery bypass grafting (CABG)
  • Aortic anastomosis during CABG
  • Congenital heart surgery
  • Implantation of vascular prostheses
  • Operation for active endocarditis of the aortic root
  • Type A aortic dissection
  • Sternal wound healing
  • Surgery in high-risk patients, i.e. patients in anticoagulation therapy,
    Plavix therapy and diabetic patients

 

Cardiac Surgery

All though great advances in cardiac surgery have been made challenges still exist – some of these are:

  • Haemostasis of diffuse bleedings
  • Sealing of suture lines
  • Regeneration of tissue


 

Vivostat® offers the surgeon a choice of two products that can help with the above challenges. If haemostasis and/or sealing are the primary challenges, Vivostat® Fibrin Sealant is an excellent choice. If the primary challenge is tissue regeneration, Vivostat PRF® is the best choice

Vivostat Autologous Fibrin Sealant is an autologous sealant that outperforms other fibrin sealants on parameters such as polymerisation, elasticity, adhesion and impact on tissue.

Vivostat PRF® is a second generation platelet enriched product acting both as a haemostat/sealant while at the same time supporting tissue regeneration and wound healing.

 

SUPPORTING EVIDENCE IN CARDIAC SURGERY

 

Application of Platelet Rich Fibrin to prevent infection in the implantation of HeartWare®-LVAD-system
R. -U. Kühnel, T. Müller, M. Hartrumpf, M. Erb, J. M. Albes
Kardiotechnik 2013: 22(2):43-45

Use of topical heamoatatic agents to control perioperative bleeding in cardiac surgery
P. Nardi et al.
Presented at The Onassis Cardiac Surgery Center, September 2010

Minimally invasive Ross procedure through partial upper sternotomy
U. F.W. Franke, M. Albert, C. Rustenbach and H. Baumbach
Interact CardioVasc Thorac Surg 2009;9:545-546

Important steps to avoid tamponade in minimally invasive aortic valve replacement
S. Foghsgaard, H. K. Kjaergard
Department of Cardiothoracic Surgery, Gentofte Hospital, Denmark

A Comparison of the Haemostatic Effect of Vivostat Patient Derived Fibrin Sealant
J. B. Hanks, H. K. Kjaergard, D. A. Hollingsbee
European Surgical Research 2003; 35: 439-444

Vivostat System Autologous Fibrin Sealant
H. K. Kjaergard, H. R.Trumbull
The Annals of Thoracic Surgery 1998; 66: 482-486

Application of platelet rich fibrin for infection prophylaxis during implantation of HeartWare® LVAD systems
R.-U. Kuehnel, T. Mueller, L. Romeike, M. Erb, J.M. Albes
Immanuel Klinikum Bernau Herzzentrum Brandenburg, Abteilung für Herzchirurgie, 2014

Sternal wound healing

Topical use of autologous fibrin glue in high-risk CASG patients
D. Wiedemann, D. Vill, N. Bonaros, G. Laufer, T. Schachner, A. Kocher
European surgery 2011:43/5: 309-314

The laparoscopically harvested omental flap for deep sternal wound infection
J. Wingerden, M. Coret, C. Nieuwenhoven, E. Totté
European Journal Cardiothorac Surgery 2010; 37: 87-92

Bleeding from the sternal marrow can be stopped using Vivostat® patient-derived fibrin sealant
H. K. Kjaergard, H. R.Trumbull
The Annals of Thoracic Surgery 2000; 69: 1173-1175 

The combination of vacuum therapy and Platelet Rich Fibrin – a new option in the treatment of mediastinitis
R.-U. Kuehnel, L.Michera, G.Loladze, Y. Kuhn, J. Albes
Presented at the Deutsche Gesellschaft für Wundheilung und Wundbehandlung congress 2012

Autologous Platelet Rich Fibrin PRF® using Growth Factores as a new Therapeutic Option for Sternal Wound Healing
Kuehnel R.U. et al.
Presented at World Society of Cardiothoracic Surgery 2011

Successful use of Platelet Rich Fibrin therapy (PRF) in post-operative cardiac surgical infected wounds: first reported case series
Datta, Subir
EACTS Daily News 2016; Issue 2

 

CARDIAC VIDEO

This video shows how Vivostat® is utilized in an aortic valve/ by-pass procedure.

 

 

Vivostat Fibrin Sealant applied on the Aortic Root from Vivostat A/S on Vimeo.

Aortic valve / by-pass procedure from Vivostat A/S on Vimeo.

 

 

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IN NEUROSURGERY

The Vivostat® application system possesses a number of features that are highly beneficial in neurosurgery: The Vivostat® application system offers different spray modes, e.g. “No Air” which means that it has low impact on tissue and vital organs/nerves in the skull. Furthermore, Vivostat® is applied with extreme accuracy through precision spraying.

NEUROSURGEONS MOST OFTEN CHOOSE VIVOSTAT® FOR:

  • Dural closure
  • Repair of dural defects
  • Spinal fusions
  • Tumor resections
  • Filler in “dead spaces”
Neurosurgery Sealing of Dural Closure

One of the main challenges in neurosurgery is cerebrospinal fluid (CSF) leakage. Infections are another challenge. The risk of infections increases due to “dead spaces”. It is therefore preferable to fill
these with a sterile and autologous product.

Vivostat® offers the surgeon a choice of two products, which can help
overcome these challenges. If sealing, gluing and/or haemostasis
are the primary challenges, Vivostat® Fibrin Sealant is an excellent
choice. If it is a combination of sealing, gluing, haemostasis and regeneration
of tissue, Vivostat PRF® is the ideal solution.

Vivostat Autologous Fibrin Sealant is an autologous sealant that
outperforms other fibrin sealants on parameters such as polymerisation,
elasticity, adhesion and impact on tissue.

Vivostat PRF® is a second generation platelet enriched product acting
both as a haemostat/sealant while at the same time supporting tissue
regeneration and wound healing.

SUPPORTING EVIDENCE FOR NEUROSURGERY

 

Use of fibrin sealant (Vivostat®) in skull base surgery
P.M. Baptista, S. Fernández, B. Bejarano, R. Manrique
University of Navarra, the ENT and Neuro Department, Navarra, Spain

A safety study of the use of Vivostat® patient-derived fibrin sealant containing tranexamic acid in neurosurgery
L. Poulsgaard, A. Mørck, N.E. Holm
Presented at 18th Annual Meeting of the North American Skull Base Society 2007

Use of autologous fibrin adhesive in neurosurgery
D. Bovenzi et al
Presented at SIDEM (Società Italiano di Emaferesi e Manipollazione Cellulare) 2007

Using an Autologous Fibrin Sealant in the Preventing of Cerebrospinal Fluid Leak with Large Skull Base Defect Following Endoscopic Endonasal  Transsphenoidal Surgery
Yildirim AE. et al
Turkish Neurosurgery 2013, Vol: 23, No: 6, 736-741

Autologous fibrin sealant (Vivostat®) in the neurosurgical practice: Part I: Intracranial surgical procedure
Graziano, et al
Surgical Neurology International 2015, 6:77.

Aulogous fibrin sealant (Vivostat®) in the neurosurgical practice: Part II: Vertebro-spinal procedures
Graziano. et al
Surgical Neurology International 2016, Vol: 7, Suppl 3

Vivostat: an autologous fibrin sealant as useful adjunct in endoscopic transnasal CSF-leak repair
Tomazic et. al.
Department of General Otorhinolaryngology, Head and Neck Surgery, ENT-University Hospital Graz, 2014 

 

NEURO VIDEO

The following videos illustrate how Vivostat® is used in Neurosurgery.

 

Preventing CSF leaks with Vivostat Fibrin Sealant from Vivostat A/S on Vimeo.

 

Acoustic neuroma – translabyrinthine approach from Vivostat A/S on Vimeo.

 

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IN ORTHOPAEDIC SURGERY

Multiple studies have shown the positive effects of fibrin and platelets when used in the following applications:

  • Joint replacements

  • Connective tissue repair

  • Bone Repair

Common challenges within orthopaedic surgery are bleeding and regeneration of tissue and bone. The successful handling of these challenges will have a positive effect on complications and re-operations, leading to faster rehabilitation, shorter hospital stay and lower overall procedure costs.

Achilleus Tendon Surgery

 

Vivostat offers the surgeon a choice of two products which can help overcome these challenges. If achieving haemostasis is the primary goal, Vivostat® Fibrin Sealant is an excellent choice. If the primary challenge is connective tissue regeneration, Vivostat PRF® is the best choice.

Vivostat Autologous Fibrin Sealant is an autologous sealant that outperforms other fibrin
sealants on parameters such as polymerisation, elasticity, adhesion and impact on tissue.

Vivostat PRF® is a second generation platelet enriched product acting both as a
haemostat/sealant while at the same time supporting tissue regeneration and wound healing.

Knee Surgery Procedure

1: The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery · Alsousou J et al. · J Bone Joint S. 2009;91-B:987-96
2: Fibrin sealant use for minimising peri-operative allogeneic blood transfusion · Carless P. et al. · Cochrane Database of Systematic Reviews · July 2009

SUPPORTING EVIDENCE IN ORTHOPAEDIC SURGERY

Cartilage repair evolution in post-traumatic osteochondral lesions of the talus: From open field autologous chondrocyte to bone-marrow-derived cells transplantation
S. Giannini, R. Buda, M. Cavallo, A. Ruffilli, A. Cenacchi, C. Cavallo, F. Vannini
Injury: International Journal of Care of the Injured 2010; 41: 1196–1203

Use of autologous bone marrow cells concentrate enriched with platelet-rich fibrin on corticocancellous bone allograft for posterolateral multilevel cervical fusion
G. Vadalà, A. Di Martino, M. C. Tirindelli, L. Denaro, V. Denaro
Journal of Tissue Engineering and regenerative Medicine 2008; 2: 515–520

Femoroacetabular Osteoplasty by means of anterior mini open approach combined with arthroscopy. Surgical Technique and results at a minimum followup of 4 years
V. Bellotti et al.
GIOT Febbraio 2013;39:30-38

Knee surgeons at London Bridge Hospital get stuck into the use of Biological glues
London Bridge Hospital
Health Matters 2016; Issue 18, p.11

ORTHOPAEDIC VIDEO

Following videos show how Vivostat® is used in othopaedic surgery.

Cartilage Repair

Cartilage repair – Chrondrotissue graft and Vivostat PRF from Vivostat A/S on Vimeo.

Meniscal Repair

Vivostat PRF used for meniscal repair from Vivostat A/S on Vimeo.

Total Knee Replacement

Vivostat PRF in Total Knee Replacement – Orthopaedic Surgery from Vivostat A/S on Vimeo.

Hip Replacement

Vivostat PRF in Total Hip Replacement from Vivostat A/S on Vimeo.

Golfer’s Elbow

Medial epicondylitis – Golfer’s Elbow HD from Vivostat A/S on Vimeo.

Meniscal Transplant

Vivostat PRF – Meniscal transplant from Vivostat A/S on Vimeo.

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IN THORACIC SURGERY

One of the most common complications in thoracic surgery is prolonged air leakage. Fibrin sealant has been shown to reduce the incidence of prolonged air leaks and thereby enabling faster drain removal. 

 

An optimal product solution in this special surgical field provides a number of features that are important for a positive outcome:

  • The sealant must be very elastic, i.e. it must be possible to apply on a deflated lung without compromising physical properties when the lung is re-inflated
  • Polymerization must be very fast to ensure the sealant remains where applied

surgeon operating on open wound

Surgeons find Vivostat® Fibrin Sealant most useful for the following surgical procedures: 

  • Pulmonary resections
  • Extended resections
  • Post operative bronchopleural stump fistulae
  • Spontaneous pneumothorax
  • Bullous emphysema

Fibrin Sealant After Lung Resection

An added benefit of the Vivostat®system is the option of applying the special Endoscopic Applicator When using the Endoscopic Applicator, Vivostat® Fibrin Sealant is applied through the same unique nozzle as is the case with the Spraypen®. Due to the pre-bent nozzle, the spray tip can easily be pointed in many directions, offering the surgeon freedom of control of the application, which is not obtainable with conventional systems.

SUPPORTING EVIDENCE IN THORACIC SURGERY

 

A prospective, randomized trial comparing BioGlue and Vivostat for the control of alveolar air leak
E. Belcher, M. Dusmet, S. Jordan, G. Ladas, E. Lim, P. Goldstraw
The Journal of Thoracic and Cardiovascular Surgery 2010, Volume 140, Number 1; 32-38

Autologous fibrin sealant reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery
C. Moser,
 I. Opitz, W. Zhai, V. Rousson, E. W. Russi, W. Weder, D. Lardinois
The Journal of Thoracic and Cardiovascular Surgery 2008, Volume 136, Number 4; 843-849

The effect of autologous fibrin sealant (Vivostat) on morbidity after pulmonary Lobectomi – a prospective randomized, blinded study
A. Belboul, L. Dernevik, O. Aljassim, B. Skrbic, G. Rådberg, D. Roberts 
European Journal of Cardio-thoracic Surgery 2004; 26: 1187–1191

A prospective randomized trial comparing homologous and autologous fibrin sealants for the control of alveolar air leak
B. Kılıç, E.Erşen, A. Demirkaya, H. Volkan Kara, N. Alizade, M. İşcan, K. Kaynak, A. Turna
European Journal of Thoracic Disease 2017; 9(9): 2915-2922

Autologous Fibrin sealant (Vivostat) in General Surgery Post interventional survey at three exemplary patients
J. Jacobs
Department of Thoracic Surgery and Thoracic Endoscopy; Essen, Germany

Autologer Fibrinkleber in der Thoraxchirurgie Machbarkeitsstudie in einen Zentrum 
J. Jacobs, S. Welter, M. Altmayer, A. Breull, G. Stamatis 
Presented at DACH 2010

 

THORACIC VIDEO

The following videos illustrate how Vivostat® is used in thoracic surgery.

 

Wedge resection

Multiple wedge resection from Vivostat A/S on Vimeo.

Bronchial stump insufficiency

Bronchial stump insufficiency from Vivostat A/S on Vimeo.

 

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IN VASCULAR SURGERY

Vascular surgeons find Vivostat® Fibrin Sealant most useful for the following surgical procedures:

  • Aortic aneurysm resection

  • Peripheral bypass

  • Carotid endarterectomy

Vivostat Fibrin Sealant for Bifurcation Graft

Fibrin Sealant has been used for centuries to handle challenges in vascular surgery such as:

  • Bleeding
  • Infections
  • Re-operations
Sealing Cartorid Artery Vivostat® Fibrin Sealant is an autologous sealant that outperforms other fibrin sealants on parameters such as polymerisation, elasticity, adhesion and impact on tissue. Vascular surgeons use Vivostat®  Fibrin Sealant because of its exceptional elastic and adhesive performance on the graft surface and its ability to improve haemostasis. With these product characteristics it is possible to protect the anastomosis and reduce the risk of re-operations. Further, the surgeon is able to use Vivostat® Co-Delivery to apply a given substance with the Vivostat® Fibrin Sealant.

VASCULAR VIDEOS

These videos illustrate how Vivostat® is used in vascular surgery.

Abdominal aorta

Vascular surgery – abdominal aorta 2 (Vivostat) from Vivostat A/S on Vimeo.

Aortic diverticulum

Vascular surgery – Aortic diverticulum (Vivostat) from Vivostat A/S on Vimeo.

Carotid artery

Vascular surgery – Carotid artery (Vivostat) from Vivostat A/S on Vimeo.
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IN WOUND CARE

Platelets containing essential growth factors are increasingly used in treating challenging wounds. Vivostat Platelet Rich Fibrin (PRF® ) has successfully been used to treat:

 

 

  • Diabetic foot ulcers

  • Venous ulcers

  • Pressure ulcers

    • Surgical wounds

    • Skin grafts

 

The combination of platelets and fibrin in Vivostat PRF® is unique.
Not only does the fibrin protect the platelets from proteolytic degradation,
it also ensures the slow release of growth factors over time and makes
the PRF®solution polymerize immediately upon application, which means
that the platelets stay where they are applied.
Learn more about the Vivostat PRF®product characteristics here.

The Vivostat®fully automated processing system secures a consistent, high number of platelets
extracted from the patient’s own blood. Learn more about the Vivostat® system here

Vivostat A/S also offers wound care specialists the flexible wound treatment, Vivostat®Wound Therapy, that combines Growth Factors, Antibiotics and Vagus Stimulation. Vivostat®Wound Therapy consists of 3 scientifically proven techniques that separately or in a combination can effectively combat non-healing wounds!

 

SUPPORTING EVIDENCE IN WOUND THERAPY

 

Use of autologous platelet-rich fibrin on hard-to-heal wound
P. Steenvoorde, L.P. van Doorn, C. Naves, J. Oskam 
Journal of Wound Care 2008; 1 7 (2 ): 60-63 

Our experience in the treatment of chronic ulcers using Vivostat® PRF®. Series of 10 cases
M. Fuertes, V. Velasco, G.E. Larrañagag, G. Peirona
Cir. plást. Iberolatinoam 2009; 35 (2): 141-148

Clinical Experience of Vivostat® Platelet Rich Fibrin (PRF®) in treatment of Diabetic foot ulcers
M. Löndahl
Presented at the 13eme Conference nationale des plaies et cicatrisations 2009

Comparative Study of two different treatment methods using autologous thrombocyte-fibrin treatment of diabetic foot ulcers
G. Larsson, M. Löndahl
Presented at Jubileumsriksstämman 2008

Growth factor and proteinase profile of Vivostat platelet-rich fibrin linked to tissue repair
M. S. Agren, K. Rasmussen, B. Pakkenberg & B. Jørgensen
Vox Sanguinis (2013); 107(1), 37-43

Autologes thrombozytenreiches Fibrin – eine neue Möglichkeit zur Wundtherapie bei komplizierten chronischen Wunden
K.P. Arenth, C. Schneider, D. Ockert
Wundtherapie bei komplizierten chronischen Wunden 2009

Selected case stories, Vivostat® platelet rich fibrin (PRF®) in the treatment of chronic wounds
B. Jørgensen, M. Löndahl,G. Larsson, H. Monberg
Published in the Swedish wound magazine “Sår” – March 2008

Vivostat PRF® for the treatment of hard to heal ischemic diabetic ulcer
P. Steenvoorde, L. van Doorn, J. Oskam
From the department of SurgeryRijnland Hospital Leiderdorp and the Rijnland Wound Clinic Leiderdorp, in the Netherlands

Use of autologous growth factors to heal chronic wounds
D. Sommer
Forum Sanitas – The Informative Medical Magazine 2008

Platelet Rich Fibrin (PRF) for hard to heal ulcers in patients with diabetic feet
C. Naves, P. Steenvoorde, L. Van Doorn
European Tissue Repair Society 2008

Autologus Platelet-Rich Fibrin for the treatment of hard to heal diabetic ulcers
L. van Doorn, P. Steenvoorde, J. Oskam
Noordwijkerhout 2007

Platelet Rich Fibrin seems to be a safe and effective treatment in diabetic patients with lower extremity fistula
Å. Asmundsson, M. Löndahl, I. Dupros, G. Larsson, P. Katzman
Skane University Hospital (Lund, SWEDEN)

Effects of locally applied autologous Platelet-Rich Fibrin® (PRF®) on split-thickness skin graft donor sites
P. Danielsen, B. Jørgensen, T. Karlsmark, L.N. Jørgensen, M. Ågren
Presented at EWMA 2010

Platelet gel applications in oral mucositis in CGVHD
A.S. Ferraro et al.
Presented at the European Hematology Association Congress 2008

Application of PLTs gel for the treatment of refractory chronic GvHD skin lesions
A. Picardi et al.

Presented at the meeting European Group for Blood and Marrow Transplantation

Tension free Primary Closure with Autologous Platelet Gel Versus VivostatTM for the Definitive Treatment of Chronic Sacrococcygeal Pilonidal Disease
Gipponi et al

In vivo 24: 583-590 (2010)

Autologes thrombozytenreiches Fibrin kombiniert mit vagaler Stimulation
T. Payrits et. al
Skriptum Kongressjournal, 12. Jahrestagung der Österreichischen gesellschaft für Wundbehandlung
10 April, 2010

Platelet Rich Fibrin seems to be a safe and effective treatment in diabetic patients with lower extremity fistula
M. Løndahl et. al

Platelet gel applications in oral Mucisitis in CGVHD
A.S. Ferraro et. al
13th Congress of the European Hematology Association
June 12-15, 2008

Platelet-released growth factors induce the antimicrobial peptide human beta-defensin-2 in primary keratinocytes
Bayer et. al
Experimental Dermatology, 2016, 25, 460–465

 

WOUND CARE VIDEO

The following videos show how Vivostat PRF® is used to treat wounds.

 

Treatment of foot wound from Vivostat A/S on Vimeo.

Perianal fistula treated with Vivostat PRF from Vivostat A/S on Vimeo.