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New Spine Implant from Spineology Receives FDA Approval

New Spine Implant from Spineology Receives FDA Approval

The device is intended to support the lower spine, an area where the Oakdale-based company as of yet did not have a product to offer.

The Food and Drug Association granted Oakdale-based Spineology Inc. approval to sell its new spine implant to hospitals around the nation.
 
On Tuesday, Spineology announced the clearance of its Rampart One Anterior Lumbar Interbody Fusion (ALIF) System, which screws into the lumbar section at the end of the spine, providing additional support for patients suffering from lumbar degenerative disc disease and other conditions.
 
“We are very excited about this approval and look forward to entering the anterior market in the near future,” John Booth, CEO of Spineology, said in a statement.
 
Doctors praised Spineology’s new device, noting its use during an ALIF surgery where doctors approach from the front of a patient, making an incision at the abdomen, versus entering from a patient’s backside. Dr. Jeremy Shore of Boston said surgeons would be able to minimize the incision’s size due to the implant’s integrated guides and variable angle instrumentation.
 
“For instances where there is limited to no vessel mobility, the Rampart One Oblique footprint is an excellent option,” said Dr. Clifford Tribus, a faculty member at the University of Wisconsin’s School of Medicine and Public Health.
 
Spineology has had recent success pushing products through the FDA approval process. In October, the company was cleared to sell its Rampart Duo implant device, which is used to maintain sagittal alignment (or a front-to-back imbalance in the spine) during surgery.