A Medical Device Daily

Paradigm Spine (New York), a developer of posterior non-fusion spinal implant solutions, reported that the first two surgeries had been completed successfully in its IDE trial for coflex, a functionally dynamic interspinous implant for the treatment of patients suffering from lumbar spinal stenosis.

The coflex device is a U-shaped titanium alloy implant for use in patients with moderate-severe spinal stenosis, with neural element compromise, resulting in claudication and/or radicular symptoms isolated to 1 or 2 levels, in the L1-L5 region.

The first-ever coflex implant in the U.S. was performed Oct. 4, at the Loveland Surgical Center (Loveland, Colorado), by Kenneth Pettine, MD, co-inventor of the Maverick artificial disc. Pettine implanted two coflex devices in a two-level surgery.

Pettine, said, “The device is an important new option for treating patients with moderate to severe lumbar spinal stenosis and the procedure went smoothly. I look forward to continued participation in this trial.”

The second coflex surgery was performed by Dr. John Thalgott Oct. 9 at Valley Hospital (Las Vegas, Nevada).

Thalgott said, “Implantation of the coflex device, combined with a surgical decompression, is a simple, low-risk procedure that is capable of providing significant pain relief, without resorting to fusion, for many patients suffering from spinal stenosis.”

Paradigm received FDA approval earlier this year for the randomized study involving 460 patients. The coflex device will be compared with pedicle-screw fusion, the current standard of care.

Marc Viscogliosi, CEO of Paradigm Spine, said, “The coflex device has over 12 years of clinical history outside the United States, with more than 20,000 patients. These initial procedures keep us on our schedule of enrolling patients in the trial.”

Paradigm Spine provides posterior non-fusion solutions for orthopedic spine surgeons and neurosurgeons.