25,000th iFuse Procedure Performed Worldwide

SI-BONE Inc., a 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 that the highly respected journal Spine has published the 50th peer-reviewed iFuse paper titled Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint—a Pooled Analysis¹. Compared to analyses performed in individual trials, pooling data from these three trials allowed a more statistically powerful determination of patient factors that could predict clinical outcomes after either surgery or non-surgical treatment for appropriately diagnosed patients with SI joint dysfunction.
 
The pooled analysis study included 423 patients from the three combined multicenter prospective trials, two of which were randomized controlled trials, in which 97 patients received non-surgical management (“NSM”) and 326 patients received SI joint fusion with the iFuse Implant from 2013 to 2015. Overall, positive effectiveness, durability and opioid user reduction responses were much higher in the iFuse Implant group compared to the NSM group. In the NSM group, there were no predictors of improved outcomes. In contrast, in the iFuse Implant group, smoking and opioid use were predictive of somewhat smaller improvements in pain relief and disability whereas higher patient age and longer duration of pain were predictive of larger improvements. Although statistically significant, the difference in treatment responses in these groups were clinically unimportant; that is, all subgroups had clinically large improvements after SI joint fusion with iFuse Implants.
 
“These results indicate that SI joint fusion with triangular iFuse Implants leads to better treatment outcomes compared to non-surgical management and that the extent of improvement with SI joint fusion is only modestly associated with smoking, opioid use, patient age and duration of pain,” said Daniel Cher, M.D., vice president of clinical affairs at SI-BONE and study co-author. “Some surgeons do not offer some treatments to smokers or opioid users; for SI joint fusion with iFuse Implants, however, smokers and opioid users had marked and clinically important responses.”
 
The company also announced that the iFuse Implant System has been used in more than 25,000 procedures worldwide and continues to be the Method of Choice for SI Joint FusionSM. Adoption of the iFuse Procedure has continued to grow as surgeons learn to include the SI joint as part of their routine low back pain diagnostic exam and insurance coverage for the procedure has expanded. Recently, Healthcare Service Corporation (HCSC), the 4th largest commercial health plan in the U.S., established an exclusive coverage policy for iFuse for Blue Cross Blue Shield participants in Texas, Illinois, Montana, New Mexico, and Oklahoma.
 
“These are two remarkable milestones that were made possible with over eight years of relentless dedication by our organization and thousands of health care providers who manage patients with SI joint disorders,” said Jeffrey Dunn, president and CEO of SI-BONE. “Together, we have raised awareness and educated thousands on SI joint diagnosis and treatment and with continued focus on education and clinical evidence, we are hopeful that all those suffering from chronic SI joint dysfunction who fail conservative care are able to obtain the appropriate therapy to help them.”
 
Reference
¹Dengler J, Duhon B, Whang P, Frank C, Glaser J, Sturesson B, Garfin S, Cher D, Rendahl A, Polly D, on behalf of the INSITE, iMIA, SIFI study groups. Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint: A Pooled Analysis. Spine. Published Ahead-of-Print March 27, 2017. doi:10.1097/BRS.0000000000002169