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FDA Approves Updated, Clarified Indication for Use for iFuse Implant System®
Date:4/25/2011

SAN JOSE, Calif., April 25, 2011 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint announced the U.S. Food and Drug Administration (FDA) approved a major modification to the existing product label. The Approval targets the use of iFuse Implant System® for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

In the spirit of collaboration, FDA-OSDB worked with SI-BONE, Inc. to arrive at a more accurate description of the intended use of the iFuse System. The communications were helpful in differentiating the iFuse System from fracture fixation devices. Based upon internal discussions, as well as a review of the medical literature related to SI joint disease and associated clinical care, FDA agreed to remove "fracture" from the indications for use and to further modify the indications for use statement as follows: "The SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, as the Agency believed this is more in line with the true intent of SI Joint Fusion System."

Commenting on the FDA approval of SI-BONE's 510(K), CEO, Jeff Dunn said, "This approval from the Agency provides us with a significant advantage in getting the word out on appropriate diagnosis of low back complaints that include the SI joint and that an MIS option for patients with SI joint problems and provides us with a unique opportunity to teach spine surgeons about the iFuse Implant System for SI joint fixation/fusion."

Barbara Bunger, Vice President, Clinical, Regulatory and Quality at SI-BONE stated, "It's important for companies, like SI-BONE, Inc., to work closely with the FDA in developing solutions for patients with low back complaints due to the SI joint and the company looks for
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SOURCE SI-BONE, Inc.
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