Skip to Content

Biosurgery

BiosurgeryBiosurgery

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) below:

SURGICEL® INSTAT® MCH SURGIFLO® SURGIFLO® Endoscopic-Applicator EVICEL® EVITHROM® SURGIFOAM® ETHICON® OMNEX

 

 

EVITHROM® Thrombin, Tropical (Human)

Indication

EVITHROM® is a topical thrombin 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.1

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.1

Anaphylactic reactions may occur.

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM® or bovine thrombin group)1.

References:
1. EVITHROM® Thrombin, Topical (Human) Full Prescribing Information.

 

Distributed by:
Johnson & Johnson Wound Management
P.O. Box 151, Somervile, NJ 08876-0151
USA
 

Manufactured by:
OMRIX biopharmaceuticals Ltd.
MDA Blood Bank,
Sheba Hospital, Ramar-Gan
POB 888, Kiryat Ono 55000
ISRAEL

EVICEL™ Fibrin Sealant (Human)

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.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of air or gas embolism.

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.

Anaphylactic reactions may occur.

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

See sales representative for Full Prescribing Information


 

Distributed by:
Johnson & Johnson Wound Management
P.O. Box 151, Somervile, NJ 08876-0151
USA
 

Manufactured by:
OMRIX biopharmaceuticals Ltd.
MDA Blood Bank,
Sheba Hospital, Ramar-Gan
POB 888, Kiryat Ono 55000
ISRAEL

Indication
ETHICON™ OMNEX™ Surgical Sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Contraindications
Do not use on patients with known hypersensitivity to cyanoacrylate or formaldehyde. Not for intravascular use.

See sales representative for Full Prescribing Information.