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SURGIFLO^® Hemostatic Matrix with 2 mL or 5 mL

About the Product
Clinical Information
Professional Resources
Related Information

SURGIFLO^® Hemostatic Matrix with EVITHROM^® Thrombin, Topical (Human)

Stop your Bleeding, Not your Procedure

Achieves hemostasis in 2 minutes or less when mixed with thrombin¹
Up to 24 hours working time, depending on diluent used^1,2
Volume of 8-11 mL of product may result in the use of fewer kits at a lower cost per mL than other flowable products
Includes two 12 cm applicator tips—one trimmable and a flexible tip with memory

http://www.ethicon360.com/sites/default/files/SFL-303-11_SFNG Approval Letter_CA.pdf

http://www.ethicon360.com/sites/default/files/FDA_Urologic_Exclusion_Surgiflo.pdf

http://www.ethicon360.com/sites/default/files/Core_Brochure_Surgiflo_0.pdf

http://www.ethicon360.com/sites/default/files/Surgiflo fact sheet-PI-EPI.PDF

http://prod.360.ethicon.edgesuite.net/ethicon360/biosurgery/Videos/FESS_App_Long_Surgiflo.flv

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.³

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.³

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).³

Manufactured by
OMRIX biopharmaceuticals Ltd.
Israel
License No. 1603
US-2007/09/039

Distributed by
Johnson & Johnson Wound Management
A division of ETHICON, INC.
Route 22 West
Somerville, NJ 08876

References:

Data on file, Ethicon, Inc. In vivo animal model
Full prescribing information for SURGIFLO^® Hemostatic Matrix, Ethicon, Inc.
EVITHROM^® Thrombin, Topical (Human) Full Prescribing Information.

DESCRIPTION (TOTAL VOLUME)	CODE	NDC/DISTRIBUTOR CODE	QUANTITY
6 cc SURGIFLO® Hemostatic Matrix packaged with 2000 units lyophilized thrombin	199102S	6373-1991-02S	6
6 cc SURGIFLO® Hemostatic Matrix	1991	63713-0019-91	6
6 cc SURGIFLO® Hemostatic Matrix shipped with 2 mL EVITHROM® Thrombin, Topical (Human)	199102	6373-1991-02	6
6 cc SURGIFLO® Hemostatic Matrix shipped with 5 mL EVITHROM® Thrombin, Topical (Human)	199105	6373-1991-05	6

SURGIFLO® Hemostatic Matrix with 2 mL or 5 mL

DESCRIPTION (TOTAL VOLUME)

CODE

NDC/DISTRIBUTOR CODE

QUANTITY

SURGIFLO^® Hemostatic Matrix with 2 mL or 5 mL