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SI-BONE Announces Global Clinical Strategy for Minimally Invasive iFuse Sacroiliac Joint Fusion
Date:8/1/2011

this effort is recognition that the SI joint is a significant pain generator, and that iFuse will have a role in helping to address and improve the lives of patients living with low back pain (LBP) and other debilitating musculoskeletal conditions."

John Glaser, M.D. professor of orthopedic and spine surgery at MUSC in Charleston, SC, has indicated in his experience, "the iFuse represents an alternative to traditional SI joint fusion for patients not responding to conservative therapy.  The iFuse procedure may also help treat post-lumbar fusion surgery patients who experience significant SI joint complaints following lumbar surgery.  By providing stability, after healing, with minimal dissection, iFuse allows my patients the opportunity to resume normal daily activities."

From its inception, SI-BONE has been committed to innovation and education in SI joint diagnosis and treatment.  In keeping with that goal, SI-BONE announced that it is embarking on a series of major clinical research and development initiatives on the iFuse for SI joint fusion. As part of its clinical strategy, the Company is currently conducting other research initiatives, including post-market retrospective studies, SI joint diagnosis programs, and preclinical examination of animal healing models with emphasis on imaging and histology.  

SI-BONE received clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010. The iFuse provides immediate post-operative stabilization and accomplishes the goal of traditional SI joint fusion through an MIS approach. Clinical publications have identified the SI joint as a pain generator for up to 22 percent of low back pain patients.  In addition, DePalma, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 40 to 61% of post-lumbar fusion patients, so-called
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SOURCE SI-BONE, Inc.
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