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Paradigm Spine received premarket approval for interlaminar stabilization device
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Paradigm Spine announced that the FDA has granted premarket approval for Coflex, a minimally invasive motion preserving interlaminar stabilization device for the treatment of moderate to severe stenosis with or without back pain.
In a 6-year clinical trial, 322 patients with severe spinal stenosis received surgical decompression and either Coflex interlaminar stabilization or pedicle screw fusion. According to a company press release, patients who received coflex had better or equivalent outcomes in all primary and secondary clinical and radiologic assessments, and also maintained natural motion at the treated and adjacent spinal levels. Coflex also saved from $5,000 to $8,700 per case compared to fusion through shorter operating room time, faster patient recovery, less blood loss, less narcotics usage and shorter hospital stays, while producing faster and more sustained clinical outcomes.
“Insurance companies, surgeons and patients finally have an alternative to fusion which, based on independent study data, has demonstrated that coflex produces better outcomes, a faster recovery, preserves motion and may be performed on an outpatient basis,” Marc Viscogliosi, chairman and chief executive officer of Paradigm Spine, stated in the release.