SI-BONE Inc, a San Jose, Calif-based medical device company that offers the iFuse Implant System designed for fusion of the sacrolliac (SI) joint, reports that it has been provided positive coverage for its MIS SI joint fusion procedure, thanks to a policy update published by Priority Health (Michigan) in its Lumbar Fusion Medical Policy No. 91590-R4.
A news release from SI-BONE notes the policy states that the fusion procedure, which uses the iFuse Implant System, may now be considered medically necessary for members with SI joint disruptions and degenerative sacroiliitis.
According to the release, Priority Health is the third largest commercial insurer in Michigan.
Michael Mydra, vice president of Health Outcomes and Reimbursement for SI-BONE, designates the positive coverage decision from Priority Health as a “welcome validation of the clinical benefits of the iFuse Implant System for treating patients with SI joint dysfunction directly resulting from SI joint disruptions and degenerative sacroiliitis…”
“…We are pleased that a growing number of U.S. patients seeking a minimally invasive surgical approach to pain relief from certain SI Joint disorders will now have access to this unique treatment option,” Mydra adds.
The release states that SI-BONE INC received original 510(k) clearance in November 2008 from the US Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November of 2010.
The iFuse procedure uses a small incision to allow for the delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that serves as an interface surface, the release says, intended to decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. The system is designed to accommodate sacroiliac joint fusion for conditions including SI joint dysfunction resulting from SI joint disruptions and degenerative sacroiliitis.
Source: SI-BONE Inc