San Jose, Calif-based sacroiliac joint medical device company SI-BONE Inc announces in a news release that the North American Spine Society (NASS) has issued a formal coverage recommendation for its MIS SI joint fusion procedure.
The evidence-based coverage policy, titled “Percutaneous Sacroiliac Joint Fusion, Defining Appropriate Coverage Positions,” is based primarily on the 19 SI-BONE iFuse published clinical studies. It states, according to the release, “the Coverage Committee recommends coverage for percutaneous SI joint fusion when the criteria [outlined] are met.”
The release explains that the eight criteria outlined in the document are intended to ensure that nonsurgical options have been thoroughly evaluated for at least 6 months. Also, the criteria are intended to confirm that the SI joint is in fact the primary pain source while ruling out other potential sources of pain within the lumbar spine-hip-SI joint complex through a combination of imaging studies, physical examination tests, and an intra-articular SI joint injection.
The NASS committee considered and evaluated the available published evidence, and based on that, it concluded that the SI joint is an established source of chronic low back and buttock pain and that the MIS SI joint fusion procedure has proven to be relatively safe, the release continues.
Jeffrey Dunn, president and CEO of SI-BONE, comments that NASS’ “acknowledgment of the SI joint as an established source of chronic low back pain and their recommendation for MIS SI joint fusion as a treatment option for those patients who satisfy the diagnostic criteria is a major milestone in the treatment of SI joint disorders.”
“The NASS policy recommendation further validates the existing coverage recommendation from ISASS (International Society for the Advancement of Spine Surgery) and should help to further expand coverage for the iFuse procedure throughout the US,” he explains in the release.
The SI-Bone iFuse Implant system is a minimally invasive procedure that uses titanium implants coated with a porous, titanium plasma spray that acts as an interference surface and is designed to help decrease implant motion, provide immediate fixation, and allow for biological fixation to support long-term fusion, the release explains. The procedure is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis, the release continues.
For more information, visit www.si-bone.com
[Source(s): SI-BONE Inc, PR Newswire]