A Medical Device Daily
Paradigm Spine (New York) reported that it has received an investigational device exemption from the FDA, allowing the company to begin clinical trials for its coflex device, which it describes as “a functionally dynamic interspinous implant.”
The study will involve 460 patients with lumbar spinal stenosis at up to 20 sites in a prospective randomized controlled study, comparing the coflex device with pedicle-screw fusion, the current standard of care.
The coflex device is a U-shaped titanium alloy, available in 5 sizes from 8 mm to 16 mm. It is indicated for use in patients with radiographically confirmed moderate to severe stenosis with neural element compromise resulting in claudication and/or radicular symptoms isolated to one or two levels, in the region of L1 to L5.
Gary Lowery, MD, PhD, executive vice president of research and technology for Paradigm, said, “More than 15,000 patients have been implanted with this device outside of the U.S. over the last 11 years, and our extensive retrospective analysis of this population shows outstanding results. We anticipate similar results in our U.S. trial.”
Paradigm Spine bills itself as focused on building a “multi-product non-fusion portfolio” for patients suffering from chronic back pain.