Results from the 2-year study SIFI (Sacroiliac Joint Fusion with iFuse Implant System), a prospective multicenter clinical trial of SI joint fusion, show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years. The trial included 172 subjects at 26 U.S. centers.
Success rates were 80.2% at 6 months and 79.9% at both the 12- and 24-month follow-up. Mean SI joint pain improved from 79.8 at baseline to 28.1 at 12 months and 26.0 at 24 months.
iFuse is reportedly the only commercially available MIS SI joint fusion device in the U.S. with published clinical evidence demonstrating safety and effectiveness. In 1Q16, National Government Services issued a positive local coverage determination (LCD) for MIS SI joint fusion, effective 4/1/16. The LCD enables 9.5MM Medicare beneficiaries to access SI-BONE’s iFuse procedure, if medically necessary, in 10 states.
Several companies have entered the SI joint space in recent years, including Zyga Technology, which recently enrolled patients in an expanded EVoluSIon Clinical Study focused on its SImmetry® Sacroiliac Joint Fusion.
Results from the 2-year study SIFI (Sacroiliac Joint Fusion with iFuse Implant System), a prospective multicenter clinical trial of SI joint fusion, show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years. The trial included 172 subjects at 26 U.S. centers.
Success rates were 80.2%...
Results from the 2-year study SIFI (Sacroiliac Joint Fusion with iFuse Implant System), a prospective multicenter clinical trial of SI joint fusion, show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years. The trial included 172 subjects at 26 U.S. centers.
Success rates were 80.2% at 6 months and 79.9% at both the 12- and 24-month follow-up. Mean SI joint pain improved from 79.8 at baseline to 28.1 at 12 months and 26.0 at 24 months.
iFuse is reportedly the only commercially available MIS SI joint fusion device in the U.S. with published clinical evidence demonstrating safety and effectiveness. In 1Q16, National Government Services issued a positive local coverage determination (LCD) for MIS SI joint fusion, effective 4/1/16. The LCD enables 9.5MM Medicare beneficiaries to access SI-BONE’s iFuse procedure, if medically necessary, in 10 states.
Several companies have entered the SI joint space in recent years, including Zyga Technology, which recently enrolled patients in an expanded EVoluSIon Clinical Study focused on its SImmetry® Sacroiliac Joint Fusion.
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