Floseal Hemostatic Matrix
Unmatched speed. Reliable hemostasis.1-5
From routine to unexpected bleeds, surgeons around the world trust Floseal hemostatic matrix to stop various bleeding grades. Floseal Matrix's superior performance and range of applicator tips provide precise delivery to promote hemostasis at the site of surgery.5
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Overview
Unmatched Speed. Reliable Hemostasis.1-5
Floseal Matrix is the first and only active flowable hemostat to use recombinant DNA technology.5
The thrombin component is Recothrom Thrombin Topical (Recombinant) and has the following key benefits:5
- No human blood components
- Structurally similar to human thrombin
- Eliminates reliance on human blood donations
Fast, Effective and Proven
Fast Preparation,3 Fast Hemostasis5
Floseal Matrix can be prepared in approximately one minute3 and has the potential to achieve hemostasis in as little as 60 seconds.*5
*In a RCT for spinal surgery study, hemostasis was already achieved by the one‑minute assessment, with a median time to hemostasis of 1.5 minutes (95% CI, 1–1.5).
Effective Across Surgical Specialties3
Floseal Matrix is effective across multiple surgical specialties at a rate of 96%*3 and demonstrates consistent performance across a range of bleeds.7-8
*Hemostasis within ten minutes—first lesion only
Proven Clinical Data4-6
In cardiac surgery, Floseal Matrix has been proven effective in heparinized patients4-5 and has demonstrated 54%* relative reductions in blood product transfusions.5-6
*Transfusion of blood products for Floseal Matrix n=31 [28.2%] vs. comparator group n=63 [60.6%, p<0.001] (Surgical Nu-Knit Hemostat or Gelfoam Hemostat).
Trusted for 25+ years
Inadequate surgical hemostasis and uncontrolled bleeding may lead to transfusion and/or other bleeding-related complications,9 lower clinical outcomes and higher hospital costs.10
For the last 25+ years, Floseal Matrix has been associated with favorable clinical outcomes and hospital resource utilization metrics.11
Features
Unique Mechanism of Action
Floseal Matrix targets the beginning and end of the coagulation cascade. The gelatin granules assist with contact activation and platelet aggregation while the thrombin converts fibrinogen to fibrin to accelerate clot formation.4 The gelatin granules swell approximately 10-20% within ten minutes upon contact with blood or other fluids creating a tamponade effect.5
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Other Information
Floseal Hemostatic Matrix Indications and Important Risk Information
Indications
Floseal Matrix is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Important Risk Information
Do not inject intravascularly.
Do not inject or compress Floseal Matrix into blood vessels.
Do not apply Floseal Matrix in the absence of active blood flow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result.
Do not administer to patients with a history of hypersensitivity to Recothrom Thrombin Topical (Recombinant), any components of Recothrom, or hamster proteins.
Do not use Floseal Matrix in patients with known allergies to materials of bovine origin.
Do not use Floseal Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges due to mechanical interposition of gelatin.
Floseal Matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis. Floseal Matrix is not intended to be used as a prophylactic hemostatic agent.
As with other hemostatic agents, do not apply Floseal Matrix to sites where there is negative peripheral venous pressure, as material may be drawn into the vascular system potentially resulting in life threatening thromboembolic events.
Excess Floseal Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation and suctioned out of the wound.
The particles of Floseal Matrix swell approximately 10-20% (upon contact with blood or other fluids) and surgeons should consider its potential effect on the surrounding anatomic areas. Maximum swell volume is achieved within about 10 minutes.
Floseal Matrix should not be used in the presence of infection. Floseal Matrix should be used with caution in contaminated areas of the body.
The safety and effectiveness of Floseal Matrix for use in ophthalmic procedures has not been established.
Floseal Matrix should not be used for controlling post-partum bleeding or menorrhagia.
The safety and effectiveness of Floseal Matrix has not been established in children under 2 years of age and pregnant women.
It is not known whether Floseal Matrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Floseal Matrix should be administered to a pregnant woman only if clearly needed.
Do not use air to remove residual Floseal Matrix from Applicator tip. The Applicator tips should not be cut, as tissue injury from sharp edges may result.
Hypersensitivity reactions, including anaphylaxis, may occur. Recothrom thrombin is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins.
For single use only. Do not re-sterilize.
Floseal Matrix should not be applied before the application site is cleaned to remove any antiseptics that may contain alcohol, iodine, or heavy metal ions.
When placed into cavities or closed tissue spaces, gentle approximation is advised. Do not compress.
As with other hemostatic agents, do not aspirate Floseal Matrix into extracorporeal cardiopulmonary bypass circuits or autologous blood salvage circuits.
Do not use Floseal Matrix on bone surfaces where adhesives, such as methylmethacrylate or other acrylic adhesives, will be required to attach a prosthetic device.
Floseal Matrix should not be used for the primary treatment of coagulation disorders.
The safety and effectiveness of the combined use of Floseal Matrix with antibiotic solutions or powders has not been established.
The safety and effectiveness for use in neurosurgical and urological procedures has not been established through randomized clinical studies.
In urological procedures, Floseal Matrix should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
Antibody formation to Recothrom thrombin occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.
Thrombin must be added to the Gelatin Matrix prior to use.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.
Instructions for Use:
Recothrom Thrombin Topical (Recombinant) Indications and Important Safety Information
INDICATION
Recothrom Thrombin Topical (Recombinant) is a topical thrombin indicated to aid 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 in adults and pediatric populations greater than or equal to one month of age.
Recothrom Thrombin Topical (Recombinant) may be used in conjunction with an absorbable gelatin sponge, USP.
IMPORTANT RISK INFORMATION
Do not inject directly into the circulatory system.
Do not use for the treatment of massive or brisk arterial bleeding.
Do not administer to patients with a history of hypersensitivity to Recothrom Thrombin topical (Recombinant) or any components of Recothrom or hamster proteins.
Recothrom Thrombin Topical (Recombinant) causes thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT.
Hypersensitivity reactions, including anaphylaxis, may occur.
The most common adverse reaction (incidence 6%) was thromboembolic events.
Antibody formation to Recothrom Thrombin Topical (Recombinant) occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.
Please see accompanying full Prescribing Information for Recothrom Thrombin Topical (Recombinant).
Disclaimer
Rx only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
Baxter, Coseal, Floseal, Perclot and Recothrom are trademarks of Baxter International Inc. or its subsidiaries. Any other trademarks, product names or brand images are the property of their respective owners.
References
- Renkens KL, Payner TD, Leipzig TJ, et al. A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine. 2001;26:1645-1650.
- Tackett SM, Sugarman R, Kreuwel HT, et al. Hospital economic impact from hemostatic matrix usage in cardiac surgery. J Med Econ. 2014;17(9):670-676.
- Time and Motion Study. BXU569412. [Baxter Data on File]. March 25, 2022.
- Oz MC, Cosgrove DM, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg. 2000;69:1376-1382.
- Floseal Hemostatic Matrix Instructions for Use. Baxter Healthcare.
- 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(5):1520-1526.
- Slezak P, et al. Efficacy of Topical Hemostatic Agents: A Comparative Evaluation of Two Gelatin/Thrombin-Based Hemostatic Matrices in a Porcine Kidney Surgical Model. J Invet Sug. 2018:1-8.
- Baxter Healthcare. Data on File. Study No. BXU574822. February 14, 2022.
- Stokes et al.: Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Services Research 2011 11:135
- Corral et al. Health and economic outcomes associated with uncontrolled surgical bleeding: A retrospective analysis of the Premier Perspectives Database. ClinicoEconomics and Outcomes Research. 22 July 2015.
- Khanna N, Ramirez MG, Connolly MP (2019). 20 Years of FloSeal Hemostatic Agent Use in Neurology and Spinal Surgery. J Spine Neurosurg. 8:4.