Spine Now Announces FDA Approval of New Spine System

Spine Now, LLC, based in Levittown, N.Y, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for its maxMorespine system.

Spine Now has formed an exclusive distribution agreement with Hoogland Spine Products for the maxMorespine system in the United States.

“We are excited to bring the maxMorespine system into the U.S. market and believe this system will facilitate a safer, more efficient and cost-effective alternative to other systems,” said Joan Carter, president of Spine Now and an 18-year veteran of the minimally invasive spine market.

The maxMorespine system was designed specifically for a posterorlateral transforaminal approach to perform a safe, targeted, foraminotomy for restoration of the spine neuro anatomy.The innovative, patented instruments provide access to all lumbar disc levels as well as versatile manipulation and treatment of disc pathology without unnecessary destabilization of the spine or intervertebral disc, which results from open spine surgery.

The device uses local anesthetic, a small incision, muscle splitting rather than cutting, avoids destabilization of the spine and targets “pain generators,” which preserves surrounding anatomy and thus function, resulting in reduced post-operative discomfort, less scar tissue formation and an earlier return to a productive lifestyle, according to the company.

The maxMorespine system is manufactured by Hoogland Spine Products GmbH in Munich, Germany.