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 it?

A novel patented biotechnological process that enables reliable and reproducible preparation of autologous fibrin sealant and related products without using cryoprecipitation and without the need for a separate thrombin component.

The Vivostat® Fibrin Sealant:

• is derived from the patient's own blood
• does not contain any bovine components (like most other products on the market).
• is completely aprotinin-free.
• is straightforward and intuitive, meaning that there is no need for specially trained personnel.

A revolution in fibrin sealant technology

JUST 23 minutes: The fully automated Vivostat® system prepares 5-6 ml of autologous fibrin sealant from 120 ml of the patient’s own blood in just 23 minutes.

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.

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

• 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.

  

• Elasticity
  Surgical sealants must be very flexible to move with the tissue. This is especially important with organs like the lungs as the sealant might be applied when the lung is deflated. 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.

  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.

  The graph below shows the elongation at break (mm) for Vivostat® compared with two conventional fibrin sealants after 20 seconds.

  

• Adhesion
  Strong adhesion to tissue 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.

  

• Reproducibility
  Unlike other patient-derived fibrin sealants, the fibrin concentration in the Vivostat® end-product is independent on the source or the plasma fibrinogen level.

  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.

[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