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An Innovative Sealing Hemostat

Wed, 10/23/2013 - 9:00am
The Associated Press

Baxter International Inc. has announced the launch of HEMOPATCH Sealing Hemostat, a novel collagen-based hemostatic device, following CE mark approval in Europe. HEMOPATCH is a resorbable hemostatic device used for surgical procedures when control of bleeding by pressure, ligature or conventional procedures is either ineffective or impractical. The development of HEMOPATCH combined Baxter’s expertise in collagen, internal coagulation processes, and PEG (polyethylene glycol) technology platforms.

''HEMOPATCH is a valuable addition to the tools in the surgical suite, as it provides fast hemostasis and strong tissue adherence. Surgeons will appreciate that the product works quickly and effectively, does not require preparation time, and can be used in a range of surgical settings,'' said Frank Ulrich, M.D., head of surgical oncology at Goethe University in Frankfurt, Germany.

HEMOPATCH is a soft, thin and flexible collagen pad that is designed to allow surgeons control during application to gain hemostasis and firm adherence of the hemostatic pad to the bleeding tissue surface. In preclinical tests, HEMOPATCH achieved fast and effective hemostasis, reaching 97.5 percent success by fully controlling bleeding at two minutes.

The pad consists of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG). This gives the pad a dual-method mechanism of action, in which two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body’s own clotting mechanisms. Significant preclinical testing was conducted to confirm its hemostatic performance, biocompatibility, and safety profile.

''HEMOPATCH is a significant innovation in the field of surgical hemostasis and is a valuable enhancement to the portfolio of biosurgical products offered by Baxter,'' said Russell Holscher, vice president of research and development in Baxter’s BioSurgery business. ''Importantly, the robust development process, including evaluation of more than 400 prototypes with feedback from more than 200 surgeons, exemplifies the company’s commitment to customer-centric innovation. This hemostat will offer surgeons a valuable new tool. We plan to support the registration and launch of HEMOPATCH in additional countries in the coming years.'' About HEMOPATCH HEMOPATCH Sealing Hemostat is intended as a hemostatic device for surgical procedures when control of bleeding by pressure, ligature, or conventional procedures is either ineffective or impractical.

Important Risk Information HEMOPATCH Sealing Hemostat is not intended to be used in pulsatile, severe bleedings. The use of HEMOPATCH Sealing Hemostat is not recommended in the presence of an active infection. When used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm, care should be exercised to avoid overpacking (collagens do expand upon absorption of liquid, and may create the potential of nerve damage). HEMOPATCH Sealing Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.

Do not compress HEMOPATCH Sealing Hemostat into blood vessels or use intravascularly. The device must not be used in patients with known hypersensitivity to bovine proteins or brilliant blue (FD&C #1, blue dye).

About Baxter in BioSurgery Baxter’s BioSurgery franchise began with the acquisition of Immuno International AG, in the 1990s and the first launch of a hemostatic device in the United States in 1998. Today, Baxter’s BioSurgery portfolio consists of a range of biological and synthetic products and delivery devices used for hemostasis, tissue sealing, adhesion reduction, hard tissue regeneration, as well as soft tissue repair and microsurgery products. These products advance surgical care for surgeons and their patients in more than 60 countries across the world.

About Baxter International Inc. Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning HEMOPATCH, including expectations with regard to anticipated regulatory filings. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory approval and other requirements; actions of regulatory bodies and other governmental authorities; product quality or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

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