GELFOAM PLUS Hemostasis Kit 

GELFOAM PLUS Hemostasis Kit

Instructions for Use

The information contained in this page is intended for U.S. healthcare professionals only.

GELFOAM PLUS is the only hemostasis kit that contains the Gelfoam brand...plus Baxter's Human Thrombin.

Indications

GELFOAM PLUS is intended as a hemostatic device for surgical procedures when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical.

Thrombin (Human) used without the Gelfoam Sterile Sponge is not indicated for hemostasis.

Features

  • Offered in a convenient kit that contains: 1 Gelfoam sterile sponge (size 100), thrombin (human) dried powder, saline solution and a sterile 10 mL syringe with needle
  • Provides up to 20 mL of volume to saturate the Gelfoam sterile sponge
  • Can provide cost savings compared to items purchased separately1
  • Allows easy management of thrombin use
  • Can help consolidate inventory of multiple products
  • Can be stored at room temperature (15-25°C)

Clinical Study

  • In an animal study*, Gelfoam with human thrombin at 125 IU/mL was associated with an acceleration of hemostasis and a reduction in the amount of bleeding compared to Gelfoam and saline2

* In a porcine model, the rate of bleeding was scored at various time intervals. Data collected and analyzed on four animals. Twenty lesions were created in each animal (10 control and 10 treatment) allowing for a total of 80 lesions.

The treated group was Gelfoam Plus, and the control group was Gelfoam and saline.

Important Risk Information

  • GELFOAM PLUS is not recommended for use other than an adjunct for hemostasis.
  • GELFOAM PLUS should not be used in closure of skin incisions, because it may interfere with the healing of the skin edges.
  • GELFOAM PLUS should not be placed intravascularly, because of the risk of embolization.
  • GELFOAM PLUS contains thrombin, which is made from human plasma. It may carry the risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent.
  • GELFOAM PLUS is not recommended in the presence of infection. There have been reports of fever associated with the use of GELFOAM Sterile Sponge, without demonstrable infection.
  • While packing a cavity for hemostasis is sometimes surgically indicated, GELFOAM PLUS should not be used in this manner unless excess product not needed to maintain hemostasis is removed. Whenever possible, GELFOAM PLUS should be removed after use in laminectomy procedures and from foramina in bone, once hemostasis is achieved. This is because GELFOAM PLUS may swell to its original size on absorbing fluids, and produce nerve damage by pressure within confined bony spaces.
  • RX Only: For safe and proper use of this device, please refer to full device Instructions For Use.

References

1. 2010 IMS Hemostat and Sealant Revenue, Unit, and ASP Sales Data.
2. Gelfoam Plus [Hemostasis Kit] Instructions For Use, Hayward, CA; Baxter Healthcare Corporation. May 2009.

 

Baxter is a registered trademark of Baxter International Inc.

Gelfoam is a registered trademark of Pharmacia & Upjohn Company LLC, used under license.

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Material Safety Data Sheet

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