Call 1.800.423.2090 or Visit
www.FLOSEAL.com FAST&EFFECTIVE
SCAN AND SEE THE STOPPING
POWER OF FLOSEAL
Stops bleeding 96% of the time within 10 minutes.1
Stops bleeding
fast at the site of action (2 minutes median time to hemostasis).1
Flowable* Hemostatic Matrix in the US based on IMS data for units/mL sold Q2 2012 - Q1 20132,3
Speed to Hemostasis
Count on FLOSEAL to give you the speed to hemostasis and stopping power you need1,4 Effective and Proven Hemostasis
Effective as an adjunct to hemostasis on both low level and aggressive bleeds1,4 FLOSEAL Hemostatic Matrix Indication
FLOSEAL is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Important Risk Information for FLOSEAL
Do not inject or compress FLOSEAL into blood vessels. Do not apply FLOSEAL in the absence of active blood fl ow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result.
Do not use FLOSEAL in patients with known allergies to materials of bovine origin. Do not use FLOSEAL in the closure of skin incisions because it may interfere with the healing of the skin edges.
FLOSEAL contains Thrombin made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Excess FLOSEAL (material not incorporated in the hemostatic clot) should always be removed using gentle irrigation from the site of application. FLOSEAL swells by approximately 10-20% after product is applied. Maximum swell volume is achieved within about 10 minutes.
Adverse Events: The most common adverse events recorded for FLOSEAL and the control arm during the clinical trial (during and after application) were anemia, atrial fi brillation, infection, and hemorrhage. Adverse events (rated mild) that were deemed by the surgeon as “Possibly Related” to FLOSEAL were anemia (1%), mild post-operative bleeding (<1%), and local infl ammation (<1%).
Caution: Federal Law (United States) restricts this device to sale by or on the order of a licensed healthcare practitioner. *FLOSEAL is one of 4 fl owable hemostatic agents available in the US.
References: 1. Floseal Hemostatic Matrix Instructions for Use. Hayward, CA: Baxter Healthcare Corporation. 0717965. August 2012. 2. IMS Hospital Supply Index, 2012. 3. Spotnitz WD, Burks S. Hemostats, sealants, and adhesives: components of the surgical toolbox. Transfusion. 2008;48:1502-1516. 4. Oz MC, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg. 2000;69:1376-1382.
Baxter and Floseal are registered trademarks of Baxter International Inc. BIOS0319 07/2013
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