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Mechanism of Action

Mechanism
of Action

See how FLOSEAL works to stop bleeding fast.

Needle Free

See how FLOSEAL works to stops bleeding fast.

FLOSEAL preparation is now safer and more convenient.

Fast, Effective & Proven Hemostasis

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Reduction in transfusions

Reduction in time to hemostasis

Convenience

FLOSEAL Hemostatic Matrix is a proprietary combination of two independent hemostatic agents1,2

  • Stops bleeding fast (2 minutes median time to hemostasis) at the site of action1
  • Works on wet, actively bleeding tissue1
  • Conforms to irregular wound surfaces3
  • Effective on both hard and soft tissue1,4
  • Stops bleeding 96% of the time within 10 minutes (first lesion, per-protocol analysis)1
  • Clinically proven to control bleeding in fully heparinized cardiac patients1,2

Consistent and Effective Hemostasis1

(Secondary endpoint: time to hemostasis for the first treated bleeding site)

Consistent and Effective Hemostasis


Reduction in Transfusion of Blood Products and Minor Complications

Study methods5

Following sample size calculation in a prospective, randomized study design, an overall cohort of 209 patients were treated with FLOSEAL Matrix (FLOSEAL Matrix group) and 206 patients received alternative agents as topical hemostatic materials (comparison group). Within the overall cohort, 110 patients in the FLOSEAL Matrix group and 104 in the comparator group had intraoperative bleeding. Comparisons included hemostatic patches or sponges composed of either oxidized regenerated cellulose or purified porcine skin gelatin.

*Defined as either renal failure, respiratory insufficiency, or inotropic support lasting more than 24 hours.


Reduction in Time to Hemostasis and Revision for Bleeding

Proven clinical outcomes5

In a prospective, randomized, controlled trial for cardiovascular surgery of 209 patients and compared to 206 control patients, a cohort of patients with intraoperative bleeding was treated with FLOSEAL Matrix (n=110) or control (n=104), with either SURGICEL hemostat (oxidized regenerated cellulose) or GELFOAM® sponge (purified porcine skin gelatin). The number of patients requiring transfusion of blood products or with minor complications, as well as the hemostasis time and number of patients with surgical revisions for bleeding, were significantly less in the FLOSEAL Matrix group. No difference in major complications (stroke, shock, sepsis, or myocardial infarction) or ICU stay was observed between groups during the study.

*Operative time comprised between decannulation and closure of the sternum


Selected Important Risk Information for FLOSEAL Matrix

Excess FLOSEAL Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation from the site of application


Convenient to Use

  • Needle-free kits available in both 5 mL and 10 mL sizes can NOW be used up to 8 hours after mixing with thrombin solution1
  • All-in-one package with human thrombin and pre-filled sodium chloride syringe, with no refrigeration required1
  • FLOSEAL can be applied focally at the target site of bleeding1*

*Please refer to the applicable Instructions For Use for complete application techniques.


Selected Important Risk Information for FLOSEAL Hemostatic Matrix

Do not inject or compress FLOSEAL into blood vessels, or allow to enter blood vessels.

The safety and effectiveness for use in neurosurgical and urological procedures has not been established through randomized clinical studies.


View Detailed Important Risk Information »

View Instructions for Use »

References:

  1. FLOSEAL Hemostatic Matrix Instructions For Use. Hayward, CA: Baxter Healthcare Corporation.
  2. Oz MC, Cosgrove DM 3rd, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg. 2000;69:1376-1382.
  3. Oz MC, Rondinone JF, Shargill NS. FloSeal Matrix: new generation topical hemostatic sealant. J Card Surg. 2003;18:486-493.
  4. Renkens KL Jr, Payner TD, Leipzig TJ, et al. A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine. 2001;26:1645-1650.
  5. Nasso G, Piancone F, Bonifazi R, et al. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg. 2009;88:1520-1526.