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

SAN JOSE, Calif., Sept. 10, 2013 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System®, a minimally invasive surgical (MIS) device to fuse the sacroiliac (SI) joint, announced today that over 8,500 patients have been treated with the iFuse resulting in over 25,000 iFuse implants placed in patients worldwide.  The iFuse implant has a unique triangular-shaped profile and is coated with a titanium plasma spray (TPS) porous coating.  The TPS coating allows for biological fixation and the implant is designed to stabilize and fuse the SI joint.  Since the company was founded in 2009, acceptance and adoption of the iFuse Implant System as a surgical solution for patients suffering from SI joint pain has grown dramatically.

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It is estimated that minimally invasive SI joint fusion accounts for nearly 90% of all SI joint fusions currently performed in the U.S.1 and the iFuse Implant System accounts for over 90% of all of these minimally invasive procedures.  Over 600 surgeons have performed iFuse procedures in 16 countries around the world and marketing approval is expected in over a dozen additional countries within the next nine months.  Published data from a database of 5,319 patients indicates that the rate of serious complications, including revisions, is less than 3.8%.2  In addition, two separate surgeon case series report patients benefit from early clinically significant pain reduction that is sustained out to 12 and 24 months with 82% and 100% surgical outcome satisfaction.3,4  In fact, the iFuse Implant System is the only device used in minimally invasive SI joint fusion for which there is publishe
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SOURCE SI-BONE, Inc.
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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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