Orthofix (OFIX) Reports Encouraging M6-C Disc Study Results
Zacks Investment Research | Apr 08, 2019 08:39AM ET
Orthofix Medical Inc. (NASDAQ:OFIX) recently announced favorable results from its two-year U.S. Investigational Device Exemption ("IDE") study. This announcement came on the heels of the recent FDA approval of the company’s M6-C artificial cervical disc. The outcome was demonstrated at the International Society for the Advancement of Spine Surgery ("ISASS") annual meeting in Anaheim, California.
The study was a non-randomized, controlled clinical trial, conducted at 23 locations in the United States with an average patient age of 44 years. The primary goal of the study was to assess the safety and efficacy of the M6-C artificial cervical disc in comparison to anterior cervical discectomy and fusion ("ACDF") for the treatment of single level symptomatic cervical radiculopathy with or without cord compression.
Results of the Study
The data highlights that patients who received treatment on the M6-C artificial cervical disc witnessed some major benefits when compared to patients on the ACDF treatment. These benefits were significant reduction in neck and arm pain, improvement in neurological functions, maintenance of natural disc motion and better quality of life. Moreover, the patients using the M6-C cervical disc reported a significant alleviation in pain and much lower dependence on opioid medications in comparison to patients on ACDF treatment. After two years, patients in the ACDF group were found to have seven times higher tendency of opioid use than those in the M6-C disc group.
The clinical study data statistically demonstrated some other key advantages of the M6-C device over the ACDF treatment, viz. improvement of Neck Disability Index, significant reduction in average surgery time, higher satisfaction rate with surgery and lower incidence of adverse events.
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