ParadigmSpine has obtained premarket approval (PMA) for its motion preserving interlaminar stabilization device from the US Food and Drug Administration (FDA).
The minimally invasive coflex device is designed for treating moderate to severe spinal stenosis in patients with or without back pain and who failed over 6 months of conservative therapy.
The PMA application included positive data from a 322-patient based prospective IDE study, which is designed to compare the safety and effectiveness of coflex with pedicle screw fusion device.
Patients were randomized to receive a surgical decompression and either coflex Interlaminar Stabilization or pedicle screw fusion.
The company said implanted patients were followed up to two years and were demonstrated with radiographic, primary and secondary clinical assessments and supplemented with healthcare economic data measured through 589 data points.
Paradigm Spine Marc Viscogliosi chairman and CEO said that the study data has demonstrated that coflex produces better outcomes, a faster recovery, preserves motion and may be performed on an outpatient basis.
"This study provides the evidence insurance companies, surgeons and patients have been demanding," Viscogliosi added.
"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 executive vice president and chief medical officer Hal Mathews said, "Importantly, coflex was able to deliver better outcomes at a significantly lower cost to the healthcare system, which we believe is an important mandate of the current healthcare reform law."