, June 14, 2012
/PRNewswire/ -- Paradigm Spine, LLC, a leading provider of non-fusion "surgeon-centric" spinal implant technologies, announces the release of key findings based on its landmark coflex® IDE study.
In a podium presentation titled "Coflex® Interlaminar Stabilization Compared to Posterior Spinal Fusion", the Company highlights its study of the safety and efficacy of the coflex® interlaminar device compared to posterior spinal fusion. The study was a prospective, randomized, multi-center FDA IDE trial comparing direct decompression and coflex® interlaminar stabilization with laminectomy and posterior spinal fusion. Two hundred nineteen patients (146 coflex® and 73 fusion controls) were randomized and treated from 21 sites in the U.S. to receive direct decompression and coflex® interlaminar stabilization or laminectomy and posterolateral spinal fusion with spinal instrumentation in a 2:1 ratio.
The study's patient follow-up at 2 years was 96.6% and 98.6% for coflex® and fusion control groups, respectively. Coflex® patients experienced shorter operative times, estimated blood loss and length of stay compared to fusion controls. At 2 years, fusion controls exhibited significantly increased translation and angulation at the superior adjacent level, while coflex® maintained normal operative and adjacent level motion. In conclusion, the study results demonstrate safety, efficacy and non-inferiority of decompression followed by coflex® interlaminar stabilization compared to fusion. Coflex® led to significantly improved perioperative outcomes, multiple clinical outcomes measures and maintenance of motion at operative and adjacent levels compared with fusion at 2 years.
In a second presentation titled "Mitigation of Investigator Bias in Adverse Event Reporting", the Company highlights its success in quantifying the degree to which bias is present in adverse event reporting, and the effect that an independent Clinical Events Committee (CEC) has on mitigating this bias. During the Company's coflex® IDE study, investigators classified the severity of each adverse event, and the relationship of the event to surgery and device. An independent CEC, comprised of 3 independent, blinded spinal surgeons without affiliation to the study sponsor, reviewed all adverse event reports submitted by the investigators and re-adjudicated and re-classified all adverse event reports. All CEC adjudications were binding on the sponsor.
The results of this analysis demonstrated investigator bias in the reporting of adverse events. 37% of adverse events were adjudicated by the CEC, the vast majority of which were upgrades in the level of severity, or a designation of greater relatedness to surgery or device. This demonstrates that an independent CEC can identify and mitigate potential inherent investigator bias and facilitate an accurate assessment of investigational device safety, and should be considered requisite in future clinical trials.
About Paradigm Spine, LLC - Paradigm Spine is a privately held company focused on the design, development and marketing of solutions for the treatment of spinal conditions and diseases. The company's signature product is the coflex® device, which is currently used in over 40 countries around the world. It is an investigational device under FDA review in the United States. Once all regulatory approval requirements are met, it will be the first and only non-fusion, minimally invasive, motion-preserving device that stabilizes spinal stenosis patients after decompression due to its unique interlaminar design. For additional information visit paradigmspine.com
SOURCE Paradigm Spine, LLC