Biosurgery

Biosurgery is an area dedicated to aid in surgery by focusing on an array of technologies to minimize intra- and post-operative complications.  Solutions comprise innovative, biologically based products for surgical conditions that are often difficult or expensive to manage.

Ethicon Biosurgery offers a variety of hemostatic products, such as EVITHROM^® Thrombin, Topical (Human), EVICEL™ Fibrin Sealant (Human), SURGIFOAM* Family of Products and SURGICEL^® Family of Absorbable Hemostats and SURGIFLO^® Hemostatic Matrix.

To learn more, please click on the product(s) in the adjacent list of offerings for biosurgery.

Indication
EVITHROM^® Thrombin, Topical (Human) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

EVITHROM^® may be used in conjunction with an Absorbable Gelatin Sponge, USP.

Important Safety Information

For topical use only. Do not inject EVITHROM^® directly into the circulatory system.

Do not use for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

There is a potential risk of thrombosis if absorbed systemically.

Anaphylactic reactions may occur.

Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM^® or bovine thrombin group). The most common adverse event reported was procedural complications and pruritus. None of the adverse events reported was considered casually related to EVITHROM^® administration.

Immunogenicity was evaluated by testing for the development of antibodies to highly purified antigens: human thrombin, human Factor V/Va, bovine thrombin and bovine Factor V/Va. None of the patients treated with EVITHROM^® developed antibodies to human thrombin or to human Factor V/Va.

Direct comparison of incidence of antibody development following administration of EVITHROM^® with incidence of antibody development following administration of other products may be misleading and the clinical significance of these findings is unknown.

Please see Full Prescribing Information.

Indication:

EVICEL™ Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Important Safety Information:

For topical use only. Do not inject directly into the circulatory system.
Not indicated for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeld-Jakob (CJD) agent.

Anaphylactic reactions may occur.

Most common adverse events reported in clinical trials (≥5%) are bradychardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, oedema peripheral, constipation.

*Trademark