Dr. Anthony Yeung, Principal Investigator in the study, along with investigators Dr. Christopher Yeung and Dr. Justin Field, participated in this clinical trial that led to this FDA approval. DISC, the only site in Arizona involved in this trial, was in the top 5 sites whose data was used for papers presented to national and international meetings authored by Josh Auerbach.
PARADIGM SPINE ANNOUNCES U.S. FDA PMA APPROVAL OF ITS LANDMARK COFLEX® INTERLAMINAR TECHNOLOGY
The 1st Comparative Effectiveness Study For the Treatment Of Spinal Stenosis
New York, NY, October 17, 2012 – Paradigm Spine LLC, a provider of innovative spinal implant technologies, announces the U.S. Food and Drug Administration (“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™.
- First PMA for the treatment of Moderate To Severe Stenosis With Or Without Back Pain™
- 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 (1.90 vs. 3.19 days), and coflex® surgeries were 36% faster compared to fusion (98 vs. 153 minutes)
- At 2 years follow-up, 85.8% of coflex® patients showed clinically significant improvement in pain and function (measured by Oswestry Disability Index), compared to 76.7% of fusion patients
- At 2 years follow-up, coflex® patients retained their pre-operative range of motion (within 10%) and translation (within 5%) 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.
- First PMA to collect healthcare economic data for spinal stenosis. The study data and resulting analyses demonstrate that coflex® saves the healthcare system an average of $5,000 to $8,700 per case when used as an alternative to pedicle screw fusion1.
- The coflex® study included a significant Medicare-aged patient population.
- The coflex® device, now available in the United States, has more than 18 years of clinical history with regulatory approval in over 40 countries throughout 6 continents.
Interested in Learning More?
Download and read the complete study, procedure, and findings provided by Paradigm Spine®