SI-BONE's iFuse Implant System® for SI joint fusion has been used in >25,000 procedures worldwide since its 2009 launch. The system received initial FDA 510(k) clearance in 4Q08 and CE Mark approval in 4Q10.
Furthermore, Healthcare Service Corporation, the 4th largest commercial health plan in the U.S., has recently established exclusive coverage for iFuse for Blue Cross Blue Shield participants in Illinois, Montana, New Mexico, Oklahoma and Texas.
Spine has published the 50th peer-reviewed iFuse paper, "Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Anaylsis." Pooling data from 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 included 423 patients from three multicenter prospective trials (two randomized and controlled), in which 97 patients received non-surgical management and 326 patients received SI joint fusion with iFuse from 2013 to 2015. Overall, positive effectiveness, durability and opioid user reduction responses were reported to be much higher in the iFuse Implant group compared to non-surgical management.
Sources: SI-BONE, Inc.; ORTHOWORLD Inc.