STAR is the only three-piece, mobile-bearing, non-constrained total ankle replacement system approved for uncemented use by the U.S. Food and Drug Administration, the Morrisville, Pa.-based company notes. Other total ankle replacement systems available in the United States must be implanted using bone cement.
An Investigational Device Exemption (IDE) study demonstrated STAR to be superior in efficacy and comparable in safety to fusion. The IDE and other subsequent studies also have shown the STAR ankle provides better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion. The FDA approved SBi's STAR ankle system in May 2009.
"The 5,000 implant mark is a huge milestone on the road to offering both patients and providers access to a technology with a history of clinical success," said SBi President/CEO Michael P. Simpson. "The fact that STAR has grown to become the market-leading total ankle replacement system signals its superiority in addressing a rapidly growing, unmet clinical need."
The company believes its STAR ankle leads the market in terms of volume of clinical literature - 119 published clinical papers worldwide (29 percent of all total ankle arthroplasty papers). Executives contend the STAR joint is the only total ankle replacement system with published long-term U.S. clinical results with 91 percent survivorship at an average follow-up of 9.1 years and 92 percent patient satisfaction.
Roger A. Mann, M.D., co-lead investigator in the IDE study and SBi consultant, commented: "The distinct advantage of the STAR ankle has always been its preponderance of clinical evidence. Patients want access to innovative, life-changing technologies. STAR's clinical data gives surgeons the confidence to provide patients with a technology proven to be more effective, but just as safe as the fusion alternative."
SBi was founded in 2004 by Viscogliosi Brothers, LLC (VB), a New York, N.Y.-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. The company offers a broad portfolio of products and technologies to treat trauma and diseases in the small bones and joints. In additiion to its Pennsylvania headquarters, the firm has facilities in Peronnas, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia.