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iFuse Implant System™ Receives CE Mark
Date:11/15/2010

our EU Team to develop a presence in selected EU markets to address the needs of physicians committed to treating patients with SI joint problems.  SI-BONE looks forward to entering these markets because we offer the only technology which provides an MIS solution to treat these SI joint conditions."

"Our product provides a technologically advanced alternative to the conventional open SI joint fusion as well as an option for patients who have failed conservative therapy.  The key to the iFuse procedure is the device design and minimally invasive technique.  We insert the implants across the SI joint in a one hour procedure and it gives us the stability that we need," said Mark Reiley, M.D., Chief Medical Officer and founder of SI-BONE.

The CE mark for this system follows the clearance the company received in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The iFuse is indicated for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.  

In addition to training and engaging key spine surgeons in the EU, surgeons in the US presented their initial clinical data at NASS in Orlando on October 7th. Additional retrospective data was also presented at several significant meetings, including the American Academy of Physical Medicine and Rehabilitation (AAPM&R) on November 5, the Society of Minimally Invasive Spine Surgery (SMISS) on November 6 and World Congress of Low Back & Pelvic Pain in Los Angeles on November 12.  

In response to increasing awareness of SI joint disruption and dysfunction as debilitating symptom generators, SI-BONE, Inc. developed an innovative, patented, intramedullary implant to treat the SI joint. The company is also embarking on a post-market multicenter study to determine its effect over time on SI joint pathology and on symptoms asso
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SOURCE SI-BONE, Inc.
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