The European Union has granted the CE Mark Approval to Aurora Spine, Inc. for its Zip MIS Interspinous Fusion System allowing it to be sold throughout Europe and in areas of the world that recognize the CE Mark. Aurora Spine officials describe the system as being a posterior, non-pedicle supplemental fixation device that is designed for use in the non-cervical spine. It is intended for plate fixation and attachment to the spinous process to achieve supplemental fusion in the following conditions: degenerative disc disease, spondylolisthesis, trauma and tumor. The Aurora Spine Zip MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use, according to the press release.
“The ZIP MIS Interspinous Fusion System is the first device with the unique ZIP-LOCK technology to provide simple stabilization of the spine for spinal surgery, ” said Laszlo Garamszegi, company chief technology officer. “We are very excited about the CE Mark approval and that now we are able to make this distinctive implant available to patients and surgeons all over Europe.”
Aurora Spine President and CEO Trent Northcutt said, “This is a very significant accomplishment for the company as it moves toward commercialization and its planned launch into the European markets. The CE Mark also paves the way for approvals of the ZIP MIS Interspinous Fusion System device internationally, meeting the company’s global mandate.”
Sweet!