Paradigm Spine, LLC, a developer of innovative non-fusion and fusion
spinal implant solutions, announced today that it has completed patient
enrollment in an Investigational Device Exemption ("IDE") pivotal
clinical study comparing the coflex® interlaminar technology to
instrumented posterolateral fusion in the surgical treatment of spinal
stenosis. Data from this trial will be used to support the coflex®
interlaminar technology Pre-Market Approval ("PMA") application. The
study is a prospective, randomized and concurrently controlled clinical
study involving more than 380 patients at 21 sites within the United
States. The coflex® technology, with over 15 years of clinical heritage
outside the U.S., has been implanted in more than 50,000 patients, and
is selling in over 40 countries worldwide.
“This is a very exciting time and a significant milestone for Paradigm
Spine”
The coflex® technology is a minimally invasive, non-fusion implant that
allows movement of the spine in both flexion and extension, while
providing interlaminar stabilization, foraminal distraction and facet
distraction. The coflex® is a U-shaped titanium alloy surgical device
which is implanted in the interlaminar space following a surgical
decompression. The coflex® is being evaluated in the United States for
use in patients with moderate to severe spinal stenosis, isolated to 1
or 2 levels, in the region of the first to the fifth lumbar vertebrae,
specifically L1 to L5.