Si-Bone touts BCBS SI joint fusion operation assessment rating upgrade

Si-Bone today touted that the Blue Cross Blue Shield Association assigned triangular implants for SI joint fusion, including the company’s iFuse implant, as a “moderate” quality evidence recommendation after an extensive review of safety and effectiveness data on the devices and procedures.

The “moderate” grade is the second highest on BCBSA’s four-tier rating system, according to San Jose, Calif.-based Si-Bone, and requires sufficient clinical evidence to judge health outcomes with the devices.

In the update, the BCBSA states that evidence is sufficient to show that the device, used in individuals with common disorders affecting the sacroiliac joint, produces meaningful improvement in the net health outcome of patients, Si-Bone said.

The company said that the evidence used in the upgraded assessment came exclusively from the use of its triangular iFuse implants.

The update also included assessments which graded treatments with therapeutic corticosteroid injections, radiofrequency ablation or cylindrical threaded implants as insufficient, Si-Bone said.

“There is abundant evidence showing that the sacroiliac joint is a significant contributor to lower back pain and that common types of SI joint dysfunction can be effectively treated with a minimally invasive surgical procedure using the triangular iFuse Implant, which we brought to market in 2009.  That said, the SI joint has been under-diagnosed and under-treated for decades and our philosophy has been to take a high level scientific approach, including well-designed and well-executed clinical studies so that the data from these studies could stand on their own for educational, clinical and patient purposes,” clinical affairs VP Dr. Daniel Cher said in a press release.

Last June, Si-Bone said it won FDA 510(k) clearance for its 3D-printed titanium iFuse-3D implant designed for fusion procedures to treat certain disorders of the sacroiliac joint.

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