Paradigm Spine: PMA for Coflex

First in this, first in that! Paradigm Spine LLC has announced that the FDA has granted a Premarket Approval (PMA) Order for Coflex, a minimally invasive, motion preserving interlaminar stabilization device for the treatment of moderate to severe stenosis with or without back pain. It is the first PMA for the treatment of Moderate To Severe Stenosis With Or Without Back Pain™.

As indicated by the company, this is the first prospectively randomized comparative effectiveness investigational device exemption (IDE) study that evaluated pedicle screw fusion following surgical decompression, the current standard of care for the treatment of moderate to severe spinal stenosis, as the control. This study is unique in spine because it prospectively collected Level 1 clinical, radiographic, safety and healthcare economic data. The Coflex device demonstrated better or equivalent outcomes in all major primary and secondary endpoints.

The Coflex patients spent 40% less time in the hospital compared to fusion, and Coflex surgeries were 36% faster compared to fusion. At two years follow-up, 85.8% of Coflex patients showed clinically significant improvement in pain and function, compared to 76.7% of fusion patients. Also at two years, Coflex patients retained their pre-operative range of motion and translation at the treated level and maintained normal adjacent level motion. In contrast, fusion patients experience 62% motion reduction at the treated level, and 52% increase in range of motion at the superior adjacent level. It is also the first PMA to collect healthcare economic data for spinal stenosis.

Hal Mathews, M.D., executive vice president and chief medical officer, stated in the October 17, 2012 news release, “The Coflex study results represent a celebration of evidence for surgeons, their patients and the insurance community. We now have objective evidence of the detrimental clinical effects and relatively expensive costs of pedicle screw fusion on spinal stenosis patients. Although outcomes for pedicle screw-based fusions have been historically acceptable, it was the only option surgeons had for the last 25 years to provide stabilization when indicated, along with the decompression procedure. 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.”

Marc Viscogliosi, chairman and CEO of Paradigm Spine, commented to OTW in an email,

Over the next several months, we will be introducing on a regional basis a best-in-class training program to ensure each surgeon achieves the best outcomes possible for their patients. We have ambitious expectations to make Coflex the standard-of-care for our indicated patient population and we are working with insurers nationally, regionally and locally to educate and support their initiatives to ensure responsible utilization and appropriate patient selection. We hope to be sharing more positive news of our activities over the next weeks, months and quarters. We look forward to working with you to change the spine market – one patient at a time.