Coflex is a minimally invasive, motion preserving interlaminar stabilization device, according to the company. It is designed for the treatment of moderate to severe stenosis, with or without back pain.
FDA’s approval relied upon clinical results from a six-year investigational device exemption study that compared Coflex to pedicle screw fusion.
“Based on the clinical study results, it is reasonable to conclude that a significant portion of the indicated patient population will achieve clinically significant results,” stated the FDA’s summary of safety and effectiveness data, according to the release. “In conclusion, the Coflex device represents a reasonable alternative to posterolateral fusion for the treatment of spinal stenosis.”
“This study provides the evidence insurance companies, surgeons and patients have been demanding,” said Marc Viscogliosi, chairman and CEO of Paradigm Spine, in the release. “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. For patients, the ability to walk without back pain and the progressive symptoms of stenosis is one of the most cherished functions of the aging population.”
Paradigm Spine is headquartered in New York.
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