Paradigm Spine won FDA approval for its Coflex spinal stenosis treatment system, the 1st such device to treat moderate to severe cases of spinal stenosis that may present with or without back pain.
Paradigm calls the Coflex device the "the 1st and only motion-preserving alternative to fusion for the treatment of moderate to severe spinal stenosis."
The approval was based on clinical results from the company’s investigational device exemption study that compared the Coflex device to pedicle screw fusion, the current standard of care. The results showed that Coflex met or beat fusion in all major primary and secondary endpoints, Paradigm reported.
Coflex patients spent 40% less time in the hospital and surgeries were performed 36% faster, according to the study. In addition, 85.5% of Coflex patients reported improvements in pain and function after 2 years, compared with 76.7% of patients who received the current standard of care.
The study was also the 1st to collect healthcare economic data for spinal stenosis, finding that the Coflex system could save an average of between $5,000 to $8,700 per patient when compared with pedicle screw fusion.
"These substantial cost savings were achieved through significantly shorter operating room time, faster patient recovery, less blood loss, less narcotics usage by patients, and shorter hospital stay, while producing faster and more sustained clinically successful outcomes as compared to fusion in the treatment of spinal stenosis," according to a press release.
The study included 322 spinal stenosis patients at 21 U.S. sites who had failed to get relief from 6 months of more conservative therapy. Patient follow-up was maintained at over 95%, among the highest rates for any PMA approved for a spinal device, according to Paradigm.
"The Coflex study results represent a celebration of evidence for surgeons, their patients and the insurance community," Paradigm executive vice president & chief medical officer Dr. Hal Mathews said in prepared remarks. " We now have objective evidence of the detrimental clinical effects and relatively expensive costs of pedicle screw fusion on spinal stenosis patients."
"Although outcomes for pedicle screw-based fusions have been historically acceptable, it was the only option surgeons had for the last 25 years to provide stabilization when indicated, along with the decompression procedure," Mathews added. "Importantly, Coflex was able to deliver better outcomes at a significantly lower cost to the healthcare system, which we believe is an important mandate of the current healthcare reform law."