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Biosurgery

Biosurgery Hemostasis

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 adjunctive hemostatic products, such as EVITHROM® Thrombin, Topical (Human), EVICEL® Fibrin Sealant (Human), SURGIFOAM® Family of Products, SURGICEL® Family of Absorbable Hemostats and SURGIFLO® Hemostatic Matrix.

To see Important Safety Information scroll down to the bottom of page

SURGICEL® Family of ABSORBABLE HEMOSTATS - Helps You Focus on the Procedure, Not the Bleed

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Speed, Handling, Performance...SURGICEL SNoW® Absorbable Hemostat with enhanced conformability and adherence to the bleeding site compared to SURGICEL® Original Hemostat246

EVICEL® Fibrin Sealant (Human) - Complex Problem. Simple Solution

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EVICEL® Fibrin Sealant (Human), once thawed, is ready on-demand to meet your critical bleeding challenges by working independently of your patient’s clotting factors.

SURGIFLO® Hemostatic Matrix – Don’t See Red…Stay Consistently Flowable

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Thicker matrix designed to stay where placed even during active bleeding247

ETHICON OMNEX® Surgical Sealant - Designed Specifically for Vascular Reconstruction Procedures

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ETHICON OMNEX® is a 100% synthetic sealant which forms a strong, flexible, physical seal preventing leakage of blood along suture lines in vascular reconstruction procedures.

EVICEL® Fibrin Sealant (Human)

IMPORTANT SAFETY 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 Risk Information

  • Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events.
  • Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products
  • Do not use for the treatment of severe or brisk arterial bleeding
  • Do not use EVICEL® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip to the target site cannot be ensured.
  • Life-threatening 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 pressures higher than recommended and/or at distances closer than recommended 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 gas embolism.
  • Monitor changes in blood pressure, pulse oxygen saturation, and end-tidal CO2 when spraying EVICEL because of the possibility of gas embolism.
  • To reduce the risk of potentially life-threatening gas embolism, spray EVICEL® using only pressurized CO2 gas at the recommended pressures and distances
  • Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures. Apply as a thin layer.
  • Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Prepare and administer EVICEL® according to the instructions and only with devices recommended for this product.
  • May carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent

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

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

EVITHROM® Thrombin, Topical (Human) for Topical Use Only

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.

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.
  • Hypersensitivity reactions, including anaphylaxis, may occur.
  • May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of viral transmission.
  • There is a potential risk of thrombosis if absorbed systemically.
  • 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).
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