Baxter Announces FDA Approval of GELFOAM® Plus Hemostasis Kit

The first hemostasis kit combines two important surgical tools: Baxter’s human thrombin and Pfizer’s GELFOAM

Baxter Healthcare Corporation today announced the Food and Drug Administration approval of GELFOAM ® Plus Hemostasis Kit (absorbable gelatin sponge, USP and human thrombin). GELFOAM Plus is the only available hemostasis kit that contains Pfizer’s GELFOAM ® brand plus Baxter’s Thrombin (Human) for use in controlling bleeding during surgical procedures.



“Baxter is pleased about the agreement with Pfizer and FDA approval of this combination hemostasis product,” said Ron Lloyd, vice president of Baxter’s BioTherapeutics and Regenerative Medicine business. “This reflects our commitment to providing options for use in surgical procedures, providing our customers with convenience and potential cost savings by supplying two components in a single kit.”



Baxter and Pfizer signed a marketing, supply and manufacturing agreement for GELFOAM Plus Hemostasis Kit. Under the terms of the agreement, Baxter is the exclusive distributor of GELFOAM Plus Hemostasis Kit. Pfizer will provide the sterile GELFOAM gelatin absorbable sponge and Baxter will assemble, distribute and promote the GELFOAM Plus Hemostasis Kit.



“The news of the FDA approval and agreement with Baxter is very promising for both companies,” said David J. Engels, senior director, U.S. Diversified Products at Pfizer. “GELFOAM Plus will be well received in the surgical field as it provides a practical solution using the existing GELFOAM product with Baxter’s human thrombin and has also been shown to be more effective for achieving hemostasis than the use of GELFOAM wetted with saline.”



Pfizer’s GELFOAM is indicated as a hemostatic device for surgical procedures when control of capillary, venous and arteriolar bleeding by pressure, ligature and conventional procedures is either ineffective or impractical. Baxter’s human thrombin is derived from human plasma and is used as a component in hemostatic agents and sealants for adjunctive therapy during surgical procedures.



About GELFOAM Plus Hemostasis Kit



GELFOAM Plus Hemostasis Kit is indicated as a hemostatic device for surgical procedures when control of capillary, venous, and arteriolar bleeding by pressure, ligature and conventional procedures is ineffective or impractical. Human thrombin used without the GELFOAM Sterile Sponge is not indicated for hemostasis.



Important Safety Information



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 is not recommended for use other than an adjunct for hemostasis.



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.



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.



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.



RX Only: For safe and proper use of Gelfoam Plus, please refer to full Instructions For Use. www.pfizer.com/files/products/uspi_gelfoam_plus.pdf



About Baxter’s Thrombin (Human)



Baxter’s human thrombin is made from human plasma and has been a component in products used in the surgical setting for nearly 15 years.



As with all human plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated.



About GELFOAM



GELFOAM is a sterile, pliable, surgical sponge prepared from specially treated, purified gelatin solution and capable of absorbing and holding within its meshes many times its weight in whole blood. It is used as a hemostatic device.



GELFOAM is a registered trademark of Pharmacia & Upjohn Company LLC.



About Baxter



Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE:BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients’ lives.



About Pfizer Inc



Founded in 1849, Pfizer is the world’s largest research-based pharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments, and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, nearly 90,000 colleagues in more than 150 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.