Baxter wins expanded EU indication for Hemopatch

Baxter (NYSE:BAX) said today it won CE Mark approval in the European Union for an expanded indication for its ready-to-use surgical Hemopatch.

The Deerfield, Ill.-based company’s Hemopatch is now cleared for use in closing dural defects including excision, retraction or shrinkage of the dura mater following traumatic injury. The patch is also cleared as a hemostatic device and surgical sealant for procedures where controlling bleeding, body fluid or air leakage is ineffective or impractical.

“Hemopatch now has one of the broadest indications available for advanced surgical patches in the European Union. 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,” Baxter surgical care biz global med director Dr. John Olsen said in a prepared statement.

Baxter said the new indication will allow operating surgeons in the EU to use the Hemopatch to address bleeding and seal suture lines in complex procedures, such as sealing residual air leaks during lung surgery or replacing dura mater during neurosurgery.

The company won clearance in the EU in 2013 for the Hemopatch with indications for use in hemostasis when conventional techniques are ineffective or impractical.

The company said it plans to file for expanded indications for the Hemopatch in countries outside the EU in the future.

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