Vivostat system, processor units

Regenerative Medicine · Autologous Fibrin

Vivostat® Autologous Fibrin Sealant System

Fully automated on-site preparation of autologous fibrin sealant (PRF) from the patient's own blood - no donor material. Manufactured by Vivostat A/S in Allerød, Denmark. Indicated for cardiac, soft-tissue, and orthopaedic surgery. Product family covers Vivostat® PRF, Vivostat® fibrin sealant, and Vivostat® ArthroZheal® for arthroscopic and meniscal repair.

Manufactured by Vivostat A/S (Denmark) · Distributed in Cyprus by OrganoGEN Limited

100%Patient's own blood
(no donor material)
AutomatedOn-site preparation
(point of care)
3Variants (PRF,
sealant, ArthroZheal®)
Co-deliveryOptional cells
or drugs
blockNo Donor MaterialscienceAutologous FibrinpublicCE-Markedsupport_agentSurgical Support

In One Paragraph

Vivostat® is a fully automated on-site preparation of autologous fibrin sealant (PRF, platelet-rich fibrin) sourced 100% from the patient's own blood with no donor material. Manufactured by Vivostat A/S in Allerød, Denmark. The system supports optional co-delivery of stem cells or drugs with the fibrin sealant, and is indicated in cardiac, soft-tissue, and orthopaedic surgery for haemostasis, sealing, and tissue augmentation. Product family: Vivostat® PRF, Vivostat® fibrin sealant, and Vivostat® ArthroZheal® for arthroscopic applications including meniscal repair (Skarpas 2024, PubMed 38723241). CE-marked under EU MDR 2017/745. Available in Cyprus on a private-pay or hospital-procurement basis. Distributed by OrganoGEN.

Overview

Vivostat® is a fully automated autologous fibrin-sealant system manufactured by Vivostat A/S, a biotechnology company headquartered in Allerød, Denmark. The system processes a sample of the patient's own blood on-site at the point of care to deliver a haemostatic and tissue-sealing fibrin product. Output is sourced 100% from the patient's own blood with no donor material, removing the disease-transmission and supply-chain considerations of pooled-donor fibrin products.

The system supports optional co-delivery - stem cells or drugs can be mixed with the fibrin sealant during preparation, which extends the platform into regenerative-medicine protocols alongside straight haemostasis and sealing.

The Vivostat® product family covers three variants:

- Vivostat® PRF - platelet-rich fibrin - Vivostat® fibrin sealant - for haemostasis and tissue adhesion - Vivostat® ArthroZheal® - formulated for arthroscopic applications, including meniscal repair (Skarpas 2024, PubMed 38723241)

Clinical indications span cardiac surgery, soft-tissue surgery, and orthopaedic and trauma surgery. ArthroZheal® opens an arthroscopic angle alongside other sports-medicine implants distributed by OrganoGEN.

Indications & Contraindications

check_circleIndicated For

  • Haemostasis and tissue sealing in cardiac surgery
  • Soft-tissue surgical sealing
  • Orthopaedic and trauma augmentation
  • Arthroscopic procedures including meniscal repair (ArthroZheal®)
  • Platelet-rich fibrin (PRF) applications
  • Co-delivery of stem cells or drugs with autologous fibrin

blockContraindicated For

  • Patient with contraindication to autologous blood draw
  • Severe coagulopathy precluding processing of the patient's own blood
  • Active systemic infection
  • Patient unable to comply with the operative protocol

Technical Specifications

ManufacturerVivostat A/S, Allerød, Denmark
Distributor in CyprusOrganoGEN Limited
OutputAutologous fibrin sealant (PRF, platelet-rich fibrin)
Source100% from the patient's own blood - no donor material
ProcessFully automated on-site preparation
Co-deliveryOptional mixing of stem cells or drugs with the fibrin sealant
Product variantsVivostat® PRF, Vivostat® fibrin sealant, Vivostat® ArthroZheal®
Surgical indicationsCardiac, soft-tissue, orthopaedic and trauma (haemostasis, sealing, augmentation)
RegulatoryCE-marked under EU MDR 2017/745
GESY status in CyprusPrivate-pay (hospital procurement available)

Clinical evidence

Skarpas et al. 2024

Meniscal repair with Vivostat® ArthroZheal®.

PubMed 38723241
Vivostat A/S clinical bibliography

Deep evidence base across cardiac surgery, soft-tissue sealing, orthopaedic augmentation, and arthroscopic applications. Full bibliography available to qualifying surgeons on request.

Manufacturer documentation

GESY Coverage & Pricing in Cyprus

Vivostat® is currently available in Cyprus on a private-pay or hospital-procurement basis.

Contact OrganoGEN for the current GESY status of any specific Vivostat® variant.

Frequently asked questions

Who manufactures Vivostat®?
Vivostat A/S, a biotechnology company headquartered in Allerød, Denmark. OrganoGEN is the exclusive distributor in Cyprus.
What is the Vivostat® family?
Three variants. Vivostat® PRF (platelet-rich fibrin). Vivostat® fibrin sealant (haemostasis and tissue adhesion). Vivostat® ArthroZheal® (arthroscopic applications including meniscal repair).
How is Vivostat® prepared?
Fully automated, on-site, at the point of care - a closed-system processor takes a sample of the patient's own blood and delivers the fibrin sealant during the same operative session. No off-site preparation, no donor blood involved.
What is autologous fibrin and why does it matter?
Fibrin produced from the patient's own blood. Because there are no allogeneic components, the disease-transmission and supply-chain considerations of pooled-donor fibrin products do not apply.
Can Vivostat® be combined with stem cells or drugs?
Yes. The system supports optional co-delivery - stem cells or drugs can be mixed with the fibrin sealant during preparation, extending the platform into regenerative-medicine protocols.
In which surgical specialties is Vivostat® used?
Cardiac surgery, soft-tissue surgery, and orthopaedic and trauma surgery - for haemostasis, sealing, and tissue augmentation. ArthroZheal® specifically supports arthroscopic applications.
Is Vivostat® CE-marked?
Yes. CE-marked under EU MDR 2017/745.
Is Vivostat® GESY-reimbursable in Cyprus?
Vivostat® is currently available on a private-pay or hospital-procurement basis in Cyprus. Contact OrganoGEN for the current GESY status.
Does Vivostat® support meniscal repair?
Yes. Vivostat® ArthroZheal® is the variant formulated for arthroscopic applications, with published evidence in meniscal repair (Skarpas et al. 2024, PubMed 38723241).

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Other products OrganoGEN distributes in the Regenerative Medicine category.

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Vivostat® Fibrin Sealant & PRF
Regenerative Medicine · Autologous Fibrin

Vivostat® Autologous Fibrin Sealant System

Fully automated on-site preparation of autologous fibrin sealant (PRF) from the patient's own blood - no donor material. Manufactured by Vivostat A/S in Allerød, Denmark. Indicated for cardiac, soft-tissue, and orthopaedic surgery. Product family covers Vivostat® PRF, Vivostat® fibrin sealant, and Vivostat® ArthroZheal® for arthroscopic and meniscal repair.

blockNo Donor MaterialscienceAutologous FibrinpublicCE-Markedsupport_agentSurgical Support
Vivostat system, processor units
Vivostat processor unit
Vivostat applicator unit
Vivostat applicator unit
Vivostat processor unit, display detail
Vivostat Fibrin Sealant preparation kit
Vivostat PRF preparation kit
Vivostat processor unit
Vivostat arthroscopic applicator
Vivostat arthroscopic applicator, angled tip

In One Paragraph

Vivostat® is a fully automated on-site preparation of autologous fibrin sealant (PRF, platelet-rich fibrin) sourced 100% from the patient's own blood with no donor material. Manufactured by Vivostat A/S in Allerød, Denmark. The system supports optional co-delivery of stem cells or drugs with the fibrin sealant, and is indicated in cardiac, soft-tissue, and orthopaedic surgery for haemostasis, sealing, and tissue augmentation. Product family: Vivostat® PRF, Vivostat® fibrin sealant, and Vivostat® ArthroZheal® for arthroscopic applications including meniscal repair (Skarpas 2024, PubMed 38723241). CE-marked under EU MDR 2017/745. Available in Cyprus on a private-pay or hospital-procurement basis. Distributed by OrganoGEN.

Overview

Overview

Vivostat® is a fully automated autologous fibrin-sealant system manufactured by Vivostat A/S, a biotechnology company headquartered in Allerød, Denmark. The system processes a sample of the patient's own blood on-site at the point of care to deliver a haemostatic and tissue-sealing fibrin product. Output is sourced 100% from the patient's own blood with no donor material, removing the disease-transmission and supply-chain considerations of pooled-donor fibrin products.

The system supports optional co-delivery - stem cells or drugs can be mixed with the fibrin sealant during preparation, which extends the platform into regenerative-medicine protocols alongside straight haemostasis and sealing.

Clinical Use

Indications & Contraindications

check_circleIndicated for

  • Haemostasis and tissue sealing in cardiac surgery
  • Soft-tissue surgical sealing
  • Orthopaedic and trauma augmentation
  • Arthroscopic procedures including meniscal repair (ArthroZheal®)
  • Platelet-rich fibrin (PRF) applications
  • Co-delivery of stem cells or drugs with autologous fibrin

cancelContraindicated

  • Patient with contraindication to autologous blood draw
  • Severe coagulopathy precluding processing of the patient's own blood
  • Active systemic infection
  • Patient unable to comply with the operative protocol
Technical

Technical Specifications

Manufacturer
Vivostat A/S, Allerød, Denmark
Distributor in Cyprus
OrganoGEN Limited
Output
Autologous fibrin sealant (PRF, platelet-rich fibrin)
Source
100% from the patient's own blood - no donor material
Process
Fully automated on-site preparation
Co-delivery
Optional mixing of stem cells or drugs with the fibrin sealant
Product variants
Vivostat® PRF, Vivostat® fibrin sealant, Vivostat® ArthroZheal®
Surgical indications
Cardiac, soft-tissue, orthopaedic and trauma (haemostasis, sealing, augmentation)
Regulatory
CE-marked under EU MDR 2017/745
GESY status in Cyprus
Private-pay (hospital procurement available)
Evidence

Clinical evidence

Skarpas et al. 2024 Meniscal repair with Vivostat® ArthroZheal®. PubMed 38723241
Vivostat A/S clinical bibliography Deep evidence base across cardiac surgery, soft-tissue sealing, orthopaedic augmentation, and arthroscopic applications. Full bibliography available to qualifying surgeons on request. Manufacturer documentation
GESY & Cost

GESY Coverage & Pricing in Cyprus

Vivostat® is currently available in Cyprus on a private-pay or hospital-procurement basis.

Contact OrganoGEN for the current GESY status of any specific Vivostat® variant.

FAQ

Frequently asked questions

Who manufactures Vivostat®?
Vivostat A/S, a biotechnology company headquartered in Allerød, Denmark. OrganoGEN is the exclusive distributor in Cyprus.
What is the Vivostat® family?
Three variants. Vivostat® PRF (platelet-rich fibrin). Vivostat® fibrin sealant (haemostasis and tissue adhesion). Vivostat® ArthroZheal® (arthroscopic applications including meniscal repair).
How is Vivostat® prepared?
Fully automated, on-site, at the point of care - a closed-system processor takes a sample of the patient's own blood and delivers the fibrin sealant during the same operative session. No off-site preparation, no donor blood involved.
What is autologous fibrin and why does it matter?
Fibrin produced from the patient's own blood. Because there are no allogeneic components, the disease-transmission and supply-chain considerations of pooled-donor fibrin products do not apply.
Can Vivostat® be combined with stem cells or drugs?
Yes. The system supports optional co-delivery - stem cells or drugs can be mixed with the fibrin sealant during preparation, extending the platform into regenerative-medicine protocols.
In which surgical specialties is Vivostat® used?
Cardiac surgery, soft-tissue surgery, and orthopaedic and trauma surgery - for haemostasis, sealing, and tissue augmentation. ArthroZheal® specifically supports arthroscopic applications.
Is Vivostat® CE-marked?
Yes. CE-marked under EU MDR 2017/745.
Is Vivostat® GESY-reimbursable in Cyprus?
Vivostat® is currently available on a private-pay or hospital-procurement basis in Cyprus. Contact OrganoGEN for the current GESY status.
Does Vivostat® support meniscal repair?
Yes. Vivostat® ArthroZheal® is the variant formulated for arthroscopic applications, with published evidence in meniscal repair (Skarpas et al. 2024, PubMed 38723241).
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