FDA approves 2 level cervical artificial Disc
LDR Spine, based in Austin, TX announced August 23, 2013 the receipt of a much anticipated approval letter from the Food and Drug Administration (FDA) for the surgical disc replacement of two levels of cervical symptomatic disc disruption. Pacific Spine Specialists is pleased to offer an FDA approved two level artificial disc solution for traumatic and degenerative disc disease of the cervical spine.
Previously, the major insurance carriers have only offered single level disc replacement to its insured, citing that surgery for multiple levels was investigational. The release of the FDA approval level, based on a superiority study of two level Mobi-c arthroplasty over spinal fusion, now provides that this is the new standard of care for certain types of disc disease of the cervical spine. Dr. Keenen is committed, as with single level cervical arthroplasty, to supporting the safe, judicious and efficacious use of the Mobi-c arthroplasty solution to our patients in need of disc repair surgery. We will work diligently to help the payers understand the benefits to their insured of this new and important medical treatment.