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Vivostat Sistem
Fibrin is the most basic part of the clotting mechanism. Separation of the blood into sub-products has enabled the production of fibrin, a natural tissue sealant obtained from fibrogen, for being produced and used industrially. Vivostat system, acting with this logic, in the year 1992 was first suggested raised by a group of Danish researchers looking into the possibility of improvements for a simple but fully automatic method of preparing a fibrin sealant from the patient's own blood and this idea, being further developed by Vivostat A/S after gathering the opinions of the specialists stationed in various other locations of the world, was availed to the market in the year 2001.
Vivostat is the world's only system for on-site preparation of autologous fibrin sealant and Platelet Rich Fibrin (PRF). Producing fibrin sealant or PRF for patients more than one in a very short time has now become possible. Vivostat Autologous Sealant is consistent of 3 parts:
 

Processor Unit
     
                
The Processor Unit is used to process the patient’s blood and prepare the fibrin solution. It’s patented device having high speed centrifuged technology and blood cell/fibrin sensors. It can be located in any room or corridor in the surgical department. It is often placed centrally in the department to supply multiple operating theatres. It can, however, easily be moved between operating theatres if required.
Applicator Unit              
The Applicator Unit controls the delivery of fibrin sealant to the surgical site and offers a number of different spray modes. It is positioned outside the sterile field in the operating theatre. The large display and integrated microprocessor technology automatically primes the application device and informs the surgeon of the remaining volume of fibrin sealant at all times.
 

Disposable Kit
     
        
The single-used kit contains all components needed for preparation and application of Vivostat Fibrin Sealant. It is available with a range of application devices each optimized for different surgical procedures.

A revolution in fibrin sealant technology
The fully automated Vivostat system prepares 5-6 ml of autologous fibrin sealant from only 120 ml of the patient’s own blood in just 23 minutes.
When compared with the present sealant products, Vivostat Fibrin Sealant is providing many advantages, both for the patients and the surgeons. 

  • Excellent safety profile and high biocompatibility

Vivostat Fibrin Sealant is derived from the patient’s own blood and 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 risk of bovine or human borne contaminants. This is the only way to guarantee the patient and the surgeon against viral diseases not yet identified. Moreover, any allergic reaction or antiflactic shock risk to be born by the patient is thus eliminated.

  • Unique and versatile application devices

The Vivostat System, provides single application applicators in varied models. These applicators availing the fibrin sealant, without the clogging problem generally apparent with the other available sealant systems, enabling easy distribution into the surgical area, throughout the operation provide immense and unchallenged freedom to the surgeon in using the fibrin sealant. The surgeon is thus able to perform the application of the fibrin sealant in every direction and angle, even at point areas in very close proximities.

Every applicator model, in order to increase its performance, is developed by having obtained the expertise of the specialist surgeons. The applicators, are used together with the application unit and re-operated with the micro-spray technology. The application unit, provides screened information in connection with the quantity of the fibrin sealant prepared, and contains various spray modes controlling the application of the fibrin into the surgical area in the required amounts.

Spraypen  The Vivostat Spraypen is a central and unique component of the Vivostat system. It enables the surgeon to apply Vivostat Fibrin Sealant accurately and intermittently throughout the entire procedure.
Concorde Spraypen With its carefully optimized angle on the spraytip, the Concorde Spraypen has been developed for surgical procedures where fibrin sealant must be applied in difficult to reach areas, for example anastomosis on the backside of the heart and sealing of the mammary bed.
Endoscopic Applicator  The Vivostat Endoscopic Applicator is used in various types of Minimally Invasive Surgery. The single-use endoscopic application catheter is easily used loaded into the endoscopic handle, which is inserted via a 5mm trocar. The pre-bend spraytip enables the surgeon to manipulate the tip and spray in multiple directions.

Excellent Biophysical Properties

Clinical studies and comparative tests have demonstrated that Vivostat Fibrin Sealant outperforms other fibrin sealants on important parameters such as time to hemostasis, elasticity, adhesion to tissue and impact on tissue. 
The five parameters that are most important for the efficacy of surgical sealants have been tested and compared with two conventional fibrin sealants


Elasticity                               
Surgical sealants must be very flexible to move with the tissue. This is especially important in thoracic procedures as the sealant is often applied when the lung is deflated. Most compounds have an inverse relationship between strength and elasticity. Comparative tests have, however, shown Vivostat® Fibrin Sealant to be extremely flexible, almost four times as flexible as conventional products while maintaining sufficient strength.
Adhesion                               
Numerous 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. The graph shows adhesion strength at first break and clearly demonstrates the superior performance of Vivostat® Fibrin Sealant.
Impact on tissue         
All designers of spray systems face a challenge as they want to minimize disruption or damage to the tissue caused by the high flow rate of the propellant. The Vivostat® system solves this problem with the unique design of the application devices and the Applicator Unit, which provides efficient mixing and imparts very low forces on the tissue. The graph shows the spray force (impact on the tissue) 5 cm from the nozzle.
Time to haemostasis                
An efficient sealant needs to polymerize quickly in order to build up its internal strength and provide a rapidly effective barrier. The polymerization of Vivostat® Fibrin Sealant is activated by a simple pH change and does not require an enzymes reaction. Polymerization rates are therefore much faster than conventional sealants based on fibrinogen/ thrombin. Vivostat® Fibrin Sealant obtains 80% of its full strength within only 1 minute.
Accuracy                                
The ability to accurately place the fibrin sealant increases the efficiency (faster haemostasis, rapid sealing etc.) and enables the surgeon to make better use of the fibrin that is available. Accuracy is most important in pinpoint application, in difficult to reach areas and small anastomoses. The graph shows the relative amount of fibrin that reaches a target area of 2 cm2 at the manufacturer’s recommended spray distance.




 

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