Application devices

Application devices

The Vivostat® System offers a variety of different disposable application devic­es as well as a number of reusable handles.
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Vivostat® Co-Delivery

Vivostat® Co-Delivery

The Vivostat® Co-Delivery system makes it possible to simultaneously co-apply BMAC, stem cells, chondrocytes or medications.
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Vivostat® PRF

Vivostat® PRF

Vivostat® PRF is an autologous platelet enriched fibrin matrix to support haemostasis, tissue sealing and tissue regeneration.
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Obsidian® RFT

Obsidian® RFT

Obsidian® RFT is an autologous, platelet rich bioactive matrix for regenerative treatment of fistulas providing a sphincter-sparing minimally invasive procedure.
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ArthroZheal®

ArthroZheal®

ArthroZheal® bioactive and biocompatible properties successfully provides supportive effects for sealing, healing and regeneration of ligaments, tendons and cartilage.
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Applicator Unit

Applicatator Unit

The Applicator Unit APL 404/404 series controls the delivery of the Vivostat® products to the site of treatment.
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Obsidian® ASG

Obsidian® ASG

Obsidian® ASG – Anastomoses SafeGuard, a breakthrough in regenerative surgery serves as an anastomotic reinforcement.
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Vivostat® Fibrin

Vivostat® Fibrin

Vivostat® Fibrin is an autologous concentrated fibrin sealant to support haemostasis and tissue sealing.
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Processor Unit

Processor Unit

The Processor Unit PRO 800 series is used to process the patient’s blood and prepare the Vivostat® product
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The Vivostat System

unique & autologous

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 and autologous platelet rich fibrin matrices without using cryoprecipitation and without the need for a separate thrombin component.

The solutions prepared with the Vivostat® System is intended to be used on surgical sites requiring products for haemostasis, tissue sealing and/or tissue regeneration.

The system is designed to provide the best possible solution for many different settings independent of the surgical area in which it is used.

Three easy steps – then your solutions is ready

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.
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 sealant or autologous platelet rich fibrin matrix is ready for use. No thrombin or bovine components are added to the blood at any time.

The autologous sealant/matrix solution is easily loaded into the Applicator Unit and applied to the surgical site using one of the unique application devices.

What is Vivostat® system

The Processor Unit is used to process the patient’s blood and prepare the final Vivostat® sealant or matrix solution. Read more about the Processor Unit.
The Applicator Unit controls the delivery of the Vivostat® sealant or matrix solution to the site of treatment. Read more about the Applicator Unit.

The single-use sets contains all components needed for preparation and application of the Vivostat® sealant and matrices solutions. To read more about the different solutions, please visit the Products section in the menu.

To apply the products, there is a wide range of application devices available including the possibility to co-deliver other substances with the sealant/matrix.

Surgeons in OR using Vivostat System

Watch vivostat® in action

Visit our video collection and see the Vivostat® System in action. If you are interested in specific surgical applications, please have a look at the showcase section.

Processor unit

The Processor Unit is a non-sterile, reusable, fully automated device that controls the biochemical process.

In approx. 25 min a concentrated Vivostat® sealant or matrix solution is prepared from the patient’s whole blood.

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 rooms at the same time.

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.

Applicator unit

The Applicator Unit is a non-sterile, reusable, fully automated device that controls the delivery of the Vivostat® sealant/matrix solutions.

The large display and integrated microprocessor automatically primes the application device and informs the surgeon of the remaining volume of product solution 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.

disposable sets

The disposable set comprises of two parts: a Preparation Kit used to prepare the sealant/matrix solution before surgery, and an Application Kit used to activate and apply the 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 sealant or matrix solution harvested.

Vivostat markets five different Preparation Kits; Vivostat® Fibrin, Vivostat® PRF, Obsidian® ASG, Obsidian® RFT and ArthroZheal®. To learn more about the different solution, please click the names or use the Products section in the menu.

Application Kit
The Application Kits contains the application device e.g. Vivostat® Spraypen, endoscopic catheter etc. and all other items required to prepare the system for the delivery of the sealant/matrix solution.

The application device is a sterile, disposable, hand-held device which delivers the 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 and at the same time it offers the possibility to co-apply a substance alongside the sealant/matrix. Read more about unique application devices and co-delivery options that comes with the Vivostat® System.

FAQ

We have gathered the most frequently asked questions about Vivostat® System.

If you have any other questions, you are always welcome to contact your local distributor or Vivostat.

We recommend drawing blood up to four hours before surgery.

However, there is nothing in the design or process of the Vivostat® System that prevents you from drawing blood earlier. You can fill the Preparation Unit up to 24 hours before you place it in the Processor Unit.

If the blood is drawn more than three hours before use in the Processor Unit, the Preparation Unit should be kept in the refrigerator at 5 degrees C (do not freeze). In addition, labelling and storage procedures will have to be established.

The system and preparation process are designed based on this specific volume. A reduction in blood volume will reduce the amount of fibrin. At 60 ml blood no fibrin will be produced. The Preparation Unit should therefore always be completely filled with 120 ml of blood.

Yes, this is a viable option for paediatric or anaemic patients. We recommend patients should weigh more than 20 kg to draw 120 ml blood.

The Vivostat® System operates in exactly the same way with plasma.There are just a few important things to remember:

  • It must be fresh frozen plasma.
  • You cannot use products such as SAG M or other erythrocyte products. They will not produce any fibrin as the plasma has been removed.

Vivostat® Fibrin can be prepared from heparinised blood and will perform very well on fully heparinised patients as well as patients on aspirin and warfarin therapy.

Yes, you can take blood from the heart-lung machine.

To make sure that the priming fluid and blood is fully mixed, we recommend waiting 10 minutes after the patient has been connected to the heart-lung machine before drawing the blood. We also recommend to add 100 mg Tranexmic acid to the prep-unit before drawing the blood to prevent fibrinolysis.

N.B.: Heavy blood flow from the heart lung machine might casue bubbles in the preparation unit.

Vivostat® products can be prepared and used intermittently throughout a lengthy operation without loss of effectiveness. Studies have shown that storage of Vivostat® solution for eight hours at room temperature after preparation has no significant effect on the physical properties of the derived sealant/matrix.

Yes, the revolutionary design of both the applicator devices and the delivery system enables the surgeon to cover an area of up to 60 cm2 from only 5 ml of Vivostat® sealant or matrix solution.

Yes, all disposable components used in the Vivostat® disposable sets are latex free.

Commercial fibrin sealants based on pooled blood are all treated to avoid any risk and donor blood is thoroughly tested. However, tests can only be performed for known viruses!

An example is the test for Parvovirus B19, that was only recently introduced by commercial manufacturers. A study in Japan has shown that before this test was implemented, 20% of uninfected patients were subsequently infected with Parvovirus B19 by the use of commercial fibrin sealants during surgery.

Disposable Preparation Unit for preparing ArthroZheal from Vivostat

Application devices

The Vivostat® System offers a variety of different disposable application devic­es as well as a number of reusable handles.

Vivostat® Co-Delivery

The revolutionary system makes it possible to co-apply e.g. stem cells or antibiotics with the Vivostat® product.