Small Bone Innovations, Inc. (SBi) privately held orthopedics company focused on arthroplasty, joint-related trauma technologies and treatments for the small bones and joints, reported that the Oklahoma Dept. of Labor'sWorkers' Compensation Court Insurance Dept. (OWCC) is recommending SBi's STAR total ankle replacement implant when meeting certain patient guidelines.
In a release, the Company said that it is the only total ankle system being recommended by the OWCC based upon its adopted medical treatment guidelines.
According to the US Bureau of Labor Statistics (BLS) for 2010, there were approximately 880 reported cases in Oklahoma of foot and ankle disability claims among private sector employees.
SBi said that the STAR ankle is the only total ankle replacement system approved through the US Food and Drug Administration's (FDA) rigorous Premarket Approval (PMA) process. In the PMA process, the STAR ankle's safety and effectiveness was compared with ankle fusion in a multi-center, multi-year, Investigational Device Exemption (IDE) study. The IDE study results, published in 20091, demonstrated the STAR to be superior in efficacy and comparable in safety to fusion. The IDE and other subsequent studies show that, compared to fusion, the STAR ankle has better pain relief, greater clinical success, less blood loss and a shorter operating time.
Michael P. Simpson, President & CEO of SBi, said: "Since FDA approval of the STAR in 2009, we have successfully expanded national coverage of the STAR from a single insurer to favorable policies among all major insurers based on these clinical data.
"The STAR-exclusive DWC recommendations in Texas, Oklahoma, and Kansas reflect a growing recognition of the device as the superior ankle replacement system," he added.
Anthony G. Viscogliosi, Founder & Executive Chairman of SBi added: "Oklahoma joins Texas and Kansas in endorsing disability management guidelines for workers' compensation programs that specify the STAR ankle as the only suitable ankle replacement solution. This supports a nationwide trend that emphasizes evidence- based medicine as a critical element in delivering the highest level of care to patients."
((Comments on this story may be sent to firstname.lastname@example.org))