Xtant Medical Holdings03.31.16
Belgrade, Montana-based Xtant Medical Holdings Inc., which makes regenerative medicine products and medical devices has earned FDA clearance of the Xspan Laminoplasty Fixation System through its subsidiary X-spine Systems.
The Xspan System represents the latest generation of laminoplasty fixation. Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord. Unlike a laminectomy, where the entire lamina is removed, only an opening or window is made on one side of the lamina to alleviate the compression of the spinal cord. The lamina is then restructured by a small plate which allows the spinal canal to increase in size without losing stability or movement in the vertebrae. This procedure can be completed at single or multiple levels.
The Xspan Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3).
“We are very pleased to have received clearance for Xspan,” said Dr. David Kirschman, CSO, EVP, and director of Xtant Medical. “This system will allow Xtant Medical to further differentiate itself from the competition and will better serve the growing needs of our surgeon partners.”
Xtant Medical estimates the worldwide market for laminoplasty at $110 million and growing. Xspan will be available to a limited number of key surgeons in the second fiscal quarter of 2016, with a larger general release to follow later in 2016.
The Xspan System represents the latest generation of laminoplasty fixation. Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord. Unlike a laminectomy, where the entire lamina is removed, only an opening or window is made on one side of the lamina to alleviate the compression of the spinal cord. The lamina is then restructured by a small plate which allows the spinal canal to increase in size without losing stability or movement in the vertebrae. This procedure can be completed at single or multiple levels.
The Xspan Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3).
“We are very pleased to have received clearance for Xspan,” said Dr. David Kirschman, CSO, EVP, and director of Xtant Medical. “This system will allow Xtant Medical to further differentiate itself from the competition and will better serve the growing needs of our surgeon partners.”
Xtant Medical estimates the worldwide market for laminoplasty at $110 million and growing. Xspan will be available to a limited number of key surgeons in the second fiscal quarter of 2016, with a larger general release to follow later in 2016.