Orthopedics This Week | February 16, 2016

ORTHOPEDICS THIS WEEK VOLUME 12, ISSUE 6 | FEBRUARY 16, 2016 4 5-Year Data Favors Coflex® Over Fusion for Back Pain BY ROBIN YOUNG I n a head to head, prospective, Level 1 clinical study, Coflex® beat fusion for patients with moderate to severe lumbar stenosis (up to grade 1 spondylolisthesis) at 21 clinical study sites around the U.S. at the 3 month, 6 month, 12 month, 24 month and, now, 60 month period. Just let that sink in for a minute. Better than fusion. At the five year mark. Data like this will reverberate at payers, hospitals and corporate board rooms throughout this $10 billion industry. One final point. This was a really well designed and executed FDA supervised, PMA (premarket approval) clinical study. lumbar stenosis than the current standard—pedicle screw based fixation. Game Changer One Surgeon’s Experience Consider that low back pain is the single leading cause of disability worldwide. That back pain is one of the most common reasons for missed work and the second most common reason for visits to the doctor’s office, outnumbered only by upper respiratory infections. Onehalf of all working Americans admit to having back pain symptoms each year. Scott Leary, M.D., one of the lead investigators in the study and a San Diegobased neurosurgeon, said this about using Coflex on his patients with moderate to severe lumbar stenosis: Treating low back pain—in all its forms—is roughly a $50 billion a year industry. The surgical piece of that is about $10 billion. And the foundation of the surgical segment is spine fusion surgery. But, based on this study, Coflex is a better alternative to spine fusion surgery for patients with moderate to severe Coflex/Courtesy of Paradigm Spine, LLC and photo creation by RRY Publications, LLC “A Coflex surgery is very different from a fusion surgery. It typically takes an hour and a half or less and the patients stay in the hospital only 1 or 2 nights. I make an incision that is just slightly larger than for a micro-discectomy, so there is hardly any exposure performed. This greatly limits the amount of ]\

Orthopedics This Week | February 16, 2016 | Page 4