The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Paradigm Spine’s motion-preserving interlaminar stabilisation system, designed for treating moderate-to-severe spinal stenosis.
The minimally invasive device, coflex, is developed as an alternative to posterolateral fusion for the treatment of spinal stenosis in patients with or without back pain, and who failed over six 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.
Patients were randomised to receive a surgical decompression and either coflex Interlaminar Stabilisation or pedicle screw fusion.
Implanted patients were studied over a two-year follow-up period, with radiographic, primary and secondary clinical assessments, and supplemented with healthcare economic data measured through 589 data points, according to the company.
Paradigm Spine chairman and CEO Marc Viscogliosi 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 said.
"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."
Study principal investigator Dr Reginald Davis said; "I am excited to be able to provide coflex to my patients without the need for fusion through a simple, motion preserving, and minimally invasive bone-saving surgical technique."
Paradigm Spine executive vice president and chief medical officer Dr 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."
