SAN JOSE, Calif., Jan. 23, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of a single-center retrospective study of patients who underwent SI joint fusion using titanium triangular implants or SI joint fixation using cannulated screws. The study, titled Surgical Revision after Sacroiliac Joint Fixation or Fusion1, was published in the International Journal of Spine Surgery and involved review of medical records and tailored patient follow-up contact for patients who underwent SI joint fusion or fixation between 2003 and 2015 at the site. 4-year cumulative revision rates, calculated using Kaplan-Meier survival analysis, showed a 5.7% revision rate for the 263 patients who underwent SI joint fusion with iFuse vs. a much larger 30.8% revision rate for the 36 patients who underwent SI joint screw fixation. At the longest follow-up time point, the cumulative probability of revision in the screw group was 79.8%. Subgroup analysis showed no predictors of revision other than device used (iFuse vs. screw).
“In our practice, we switched from screws to iFuse in early 2012 because we noticed that with iFuse, a much smaller proportion of patients returned to clinic with complaints of continued SI joint pain,” said Timothy Holt, MD of the Montgomery Spine Center in Montgomery, AL and senior study author. “Surgical revision was required in a large proportion of patients who underwent screw-based fixation. In contrast, the surgical revision rate with iFuse was low, similar to that reported in the literature.”
The iFuse Implant is specifically designed for SI joint fusion due to a unique triangular shape that prevents rotational motion and a porous surface that promotes bony ongrowth*. It is the only SI joint fusion device with peer-reviewed publications from prospective trials and is the only SI joint fusion device with an FDA-cleared indication citing clinical studies that demonstrate improvements in pain, patient function and quality of life.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative 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 that create an interference fit within the ilium and sacrum. The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide 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 prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results). It is the only SI joint fusion system with 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. ©2017 SI-BONE, Inc. All Rights Reserved. 9750.012317
1Spain K, Holt T. Surgical Revision after Sacroiliac Joint Fixation or Fusion. Int J Spine Surg. 2017;11:24-30. doi: 10.14444/4005.
*Data on file: TR 300401-A and 300359-A
SOURCE SI-BONE, Inc.