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SI-BONE, Inc. Announces 25,000 iFuse Implant Milestone
Date:9/10/2013

od and Drug Administration (FDA) to market its iFuse Implant System for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.

Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients.5  In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 43%, and may be as high as 61% of post-lumbar fusion, so-called "failed back surgery," patients.6  Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.

The iFuse Implant System is a commercially available device in the U.S. and Europe.   The iFuse procedure uses a small incision for delivery and implantation of titanium implants.  The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long-term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures.  The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.  As with all surgical p
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1. SI-BONE, Inc. annuncia la pubblicazione dei dati sulla sicurezza della sorveglianza post-commercializzazione per i primi 5.319 pazienti trattati con il sistema di impianto iFuse Implant System
2. SI-BONE, Inc. Announces Publication of Postmarket Surveillance Safety Data on First 5,319 Patients Treated with iFuse Implant System
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