Paradigm Spine completes enrollment in clinical study

Paradigm Spine, LLC, a developer of innovative nonfusion and fusion spinal implant solutions, announced in a press release that it has completed patient enrollment in an Investigational Device Exemption 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 in the United States. The coflex technology, with over 15 years of clinical heritage outside the United States, has been implanted in more than 50,000 patients, and is selling in over 40 countries worldwide, the company noted.

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 Paradigm release noted. The coflex is a U-shaped titanium alloy surgical device which is implanted in the interlaminar space following a surgical decompression. It 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, according to the company.

Reginald J. Davis, MD, chief of neurosurgery at Greater Baltimore Medical Center and an investigator in the study explained, “Since the coflex device is a functionally dynamic nonfusion implant, it will provide spine surgeons with the option of utilizing a less invasive, tissue sparing procedure while affording patients significant pain relief all without having to resort to fusion. I look forward to having the coflex device as part of the ‘arsenal’ of surgical options for relief of pain due to spinal stenosis.”