Baxter Launches New Room Temperature Hemopatch Sealing Hemostat for Rapid and Convenient Application During Surgery

Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced the introduction of Hemopatch Sealing Hemostat with room temperature storage at a symposium in Austria. The evolution of the product optimizes accessibility in the operating room, delivering an immediate solution for surgeons to control bleeding or prevent leakage. The product is now available to order throughout Europe.

“For over a decade, Hemopatch Sealing Hemostat has offered surgeons a reliable solution for tissue sealing, dura sealing, and hemostasis,” said Steve Wallace, president, Advanced Surgery at Baxter. “The product evolution to include room temperature storage is a result of close collaboration between surgeons and Baxter. Removing the need for refrigeration addresses the needs of our customers to have the product on hand in critical situations. We are proud to continue Baxter's legacy of innovation in sealing and hemostasis.”

HemopatchSealing Hemostat is a ready-to-use absorbable collagen pad intended for tissue sealing, dura sealing and hemostasis, and is effective and safe to use in open surgery and minimally invasive surgery. In a registry of real-world data across Europe, the product has been shown to achieve rapid and sustainable hemostasis in many surgical specialties.¹

General Surgeon, Prof. Dr. med. Selman Uranüs said, “More than 10 years ago, I first used Hemopatch Sealing Hemostat for experimental testing. Since then, I have been using it in my daily practice because of its unique characteristics as a sealing hemostatic patch, especially in laparoscopic surgery. In my opinion, eliminating the need for refrigeration and increasing product shelf life are crucial improvements because it enables surgeons to have the product available in the operating room when it matters most. After application, the product shows an enhanced adhesive strength supporting us surgeons to achieve better surgical outcomes.”²

For more information on Hemopatch Sealing Hemostat with room temperature storage, visit https://advancedsurgery.baxter.eu/hemopatch

About Hemopatch Sealing Hemostat

Hemopatch Sealing Hemostat consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). Due to its flexible structure, the application of Hemopatch Sealing Hemostat to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant.³

About Baxter

Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X, LinkedIn and Facebook.

INDICATIONS

Hemopatch Sealing Hemostat is indicated as a hemostatic device and surgical sealant across various soft tissues (cardiovascular, connective tissue, parenchyma, serosa, viscera), and dura for procedures in which control of mild or moderate bleeding or leakage of other body fluids or air by conventional surgical techniques is either ineffective or impractical. Hemopatch Sealing Hemostat may be used to augment dura closure techniques to close small dural defects (≤3mm) following traumatic injury, excision, retraction or shrinkage of the dura mater.

IMPORTANT RISK INFORMATION

• Hemopatch Sealing Hemostat is not recommended 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, the brain and/or cranial nerves, care should be exercised to avoid overpacking as Hemopatch Sealing Hemostat may expand upon absorption of liquid, creating the potential for neural 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 and sealing.
• Do not compress Hemopatch Sealing Hemostat into blood vessels or use intravascularly.

Rx Only. For safe and proper use please refer to full device Instructions for Use for Contraindications, Warnings, and Precautions.

Forward-Looking Statements

This release includes forward-looking statements concerning potential benefits associated with Hemopatch Sealing Hemostat. 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: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Hemopatch Sealing Hemostat and Baxter are registered trademarks of Baxter International Inc.

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1 Lombardo C, Lopez-Ben S, Boggi U, Gutowski P, Hrbac T, Krska L, Marquez-Rivas J, Russello D, York E, Zacharias M. Hemopatch® is effective and safe to use: real-world data from a prospective European registry study. Updates Surg. 2022 Oct;74(5):1521-1531. doi: 10.1007/s13304-022-01353-y. Epub 2022 Aug 20. PMID: 35986865; PMCID: PMC9481486.

2 Prof. Dr. med. Selman Uranüs, is one of the speakers at the symposium and has signed a speaker agreement

3 IFU Hemopatch Sealing Hemostat 09/2024

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