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SI-BONE, Inc. Announces Publication of Postmarket Surveillance Safety Data on First 5,319 Patients Treated with iFuse Implant System
Date:6/5/2013

SAN JOSE, Calif., June 5, 2013 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to fuse the sacroiliac (SI) joint, announced today the publication of the iFuse Implant System's® postmarket surveillance safety data for the first 5,319 patients treated.  The paper entitled: Analysis of the postmarket complaints database for the iFuse SI Joint Fusion System: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption, was published in Medical Devices: Evidence and Research on May 28, 2013.  The purpose of the study was to provide an analysis of postmarket surveillance complaints by evaluating SI-BONE's postmarket complaints database.  The analysis, which covers a 4-year period from April 2009 to January 2013 and includes 5,319 patients, revealed an overall postmarket complaint rate of 3.8% including a total revision rate of 1.8% and a late postoperative revision rate of 0.6%.  Revisions in the late postoperative period were performed to treat symptom recurrence or for continued pain of undetermined etiology at a median 279 days post-op.1  These rates are consistent with two previously published case series of the iFuse Implant System that reported 1-2 years post-treatment revision rates of 8% and 0%.2,3    "We are extremely proud of the safety and clinical effectiveness record that surgeons have demonstrated with the iFuse procedure.  Our core focus as a company is patient safety and procedure effectiveness at an overall reduced cost to the healthcare system.  We understand that additional clinical trials reporting on clinical outcomes will be published this year," said Jeffrey Dunn , President and CEO of SI-BONE.

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