About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System ("iFuse") from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants inserted across the joint from the ilium to the sacrum. The triangular implant shape combined with an interference press fit is designed to provide immediate fixation by minimizing rotation and joint motion. The implants' porous surface provides an ideal environment for bone ongrowth and ingrowth, facilitating long-term fusion of the joint. iFuse is the only commercially available SI joint fusion system in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including clinical results from three large multicenter prospective studies, two of which are randomized controlled trials. Currently, there are more than 45 peer-reviewed publications (www.si-bone.com/results). It is the only SI joint fusion system with an FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9754.110216
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SOURCE SI-BONE, Inc.