Deerfield, Ill., - March 24, 2016
HEMOPATCH Now Approved for Tissue Sealing and Dura Replacement in Addition to Hemostasis
Baxter International Inc. (NYSE: BAX) is committed to advancing surgical innovation and today announced the completion of CE marking in the European Union for the expanded indication of the ready-to-use surgical patch HEMOPATCH.
HEMOPATCH is now approved in the European Union for use in closing dural defects including excision, retraction or shrinkage of the dura mater following traumatic injury. It is also approved as a hemostatic device and surgical sealant for procedures in which control of bleeding or leakage of other body fluids or air by conventional surgical techniques is either ineffective or impractical.
“HEMOPATCH now has one of the broadest indications available for advanced surgical patches in the European Union,” said John Olsen, M.D., global medical director of Baxter’s surgical care franchise. “It features innovative technology, works quickly and effectively, and does not require preparation time, which means it is ready whenever it is needed by the surgeon and can be used in a range of surgical settings.”
The additional indication allows surgeons in the European Union to use HEMOPATCH to address bleeding and seal suture lines in diverse, complex procedures such as sealing residual air leaks during lung surgery, or replacing dura mater during neurosurgery preventing the loss of cerebrospinal fluid.
The development of HEMOPATCH combined Baxter's expertise in collagen, internal coagulation processes, and PEG (polyethylene glycol) technology platforms. It is a soft, thin and flexible collagen pad that is designed to allow surgeons easy control during application and does not require advanced preparation. 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.
HEMOPATCH has been approved in the European Union for use in hemostasis when conventional surgical techniques are either ineffective or impractical since 2013. Baxter anticipates filing for the expanded indication of HEMOPATCH in additional countries outside of the European Union.
Indication for Use
HEMOPATCH is intended as a hemostatic device and surgical sealant for procedures in which control of bleeding or leakage of other body fluids or air by conventional surgical techniques is either ineffective or impractical. HEMOPATCH may be used to close dural defects following traumatic injury, excision, retraction or shrinkage of the dura mater.
Important Risk Information
Do not compress HEMOPATCH into blood vessels or use intravascularly.
The device must not be used in patients with known hypersensitivity to bovine proteins or brilliant blue.
HEMOPATCH is not intended to be used in pulsatile, severe bleedings.
The use of HEMOPATCH 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, creating the potential for neural damage.
HEMOPATCH is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis and sealing.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This release includes forward-looking statements concerning HEMOPATCH, including expectations with regard to its availability in the European Union and risks associated with its use. 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 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 other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.