DEERFIELD, Ill.--(BUSINESS WIRE)--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.
