SURGIFLO® Hemostatic Matrix Kit
To see Important Safety Information scroll down to the bottom of page
Ease of Preparation and Safety247,263
- Up to 8 hours of effective working time once SURGIFLO®Hemostatic Matrix is mixed with sterile saline or thrombin
- SURGIFLO® Hemostatic Matrix stays in place even during active bleedingβ
- SURGIFLO® Hemostatic Matrix is twice as fast to prepare versus Floseal (81 vs.163 seconds) and requires no measuringΩ
- Needle-free thrombin reconstitution
- Significantly shorter thrombin reconstitution time versus Floseal (57 seconds vs. 90 seconds)
OSHA† safety guidelines recommend the use of needle-free medical devices to reduce sharp injuries in the surgical setting262
- Multi-bend blue FlexTip allows for precise placement
- Up to 8 hours of effective working time once SURGIFLO® Kit is mixed with Lyophilized human thrombin260
EVITHROM® Thrombin, Topical (Human) for Topical Use Only
Lyophilized Powder for Solution
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.
- Apply EVITHROM® on the surface of bleeding tissue only.
- The amount of EVITHROM® required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were used in conjunction with Absorbable Gelatin Sponge.
- 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.
- There is a potential risk of thrombosis if absorbed systemically.
- 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.
- 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.
- None of the patients treated with EVITHROM developed antibodies to human thrombin or to human Factor V/Va. The clinical significance of these findings is unknown.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.