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

With the Vivostat^® system this process becomes fast and uncomplicated.

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).

What is it?

• Healing the natural way
  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.

The ideal combination of fibrin and platelets

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:

Characteristics of the Vivostat® PRF

• Stimulation of fibroblast Proliferation
  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).

  

• Stimulation of fibroblast collagen synthesis
  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.

   

  

• Protection against proteolytic degradation
  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.

  

• Release of growth factors over time
  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.

   

  

[Vivostat® 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

Although great advances in cardiac surgery has 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.

Watch a video here.

[Vivostat® 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
• Polymerisation must be very fast to ensure the sealant remains where applied

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 

Watch a video here.

[Vivostat® 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

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

Achilles tendon and Vivostat PRF®

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.

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.

Watch a video here.

[Vivostat® in neuro surgery]

The Vivostat® application system possesses a number of features that are highly beneficial in neuro surgery: 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.

Neuro surgeons most often choose Vivostat® for:

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

One of the main challenges in neuro surgery is cerebrospinal fluid (CSF) leakage. Infections is 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.

Watch a video here.

[Vivostat® 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:

• Liver part resections 
• Pancreas 
• Spleen 
• Hernia mesh fixation 
• Fistulas

Vivostat® in liver surgery

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.

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® in hernia mesh

Watch a video here.

[applications]

• Cardiac surgery
• Thoracic surgery
• Orthopaedic surgery
• Neuro surgery
• Abdominal surgery
• Wound care