Si-Bone Reaches Adoption Milestone

Officials with Si-Bone Inc., the San Jose, Calif.-based makers of iFuse implant system for minimally invasive surgical (MIS) fusion for certain disorders of the sacroiliac (SI) joint, reported that more than15,000 iFuse procedures have been performed worldwide using more than 44,000 implants. 

According to the company, more than 900 surgeons having performed the procedure in the United States and 17 European countries.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long-term fusion. The system is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis.

Si-Bone officials noted that a few recent events have “helped contribute” to iFuse procedure adoption:
• In 2014, two of the eight Medicare Administrative Contractors (MACs), Novitas and Palmetto, began covering MIS SI joint fusion procedures;
• On Jan. 1, 2015 a third MAC, Noridian, began covering the procedure resulting in coverage for over 24 million Medicare beneficiaries in 28 states and the District of Columbia;
• On Jan. 1, 2015 a category I CPT Code 27279 was assigned to MIS SI joint fusion; and
• In 2015, seven states (Minnesota, New York, Utah, Michigan, Indiana, Nebraska and Georgia) and the District of Columbia have established positive coverage for almost 6 million Medicaid patients.

“We hear success stories all the time from surgeons and their patients who’ve benefited from iFuse, and it is very gratifying to see the results of our efforts lead to coverage and professional society support for MIS SI joint fusion,” said Jeffrey Dunn, president and CEO of SI-Bone. Dunn called 15,000 surgeries “a significant milestone.”

Clinical publications have identified the SI joint as a pain generator in 15-30 percent of low back pain patients and the prevalence of SI joint pain in post-lumbar fusion, so called “failed back surgery” patients, has been shown to be up to 43 percent, according to company-cited figures. Of these patients, some may have degenerative sacroiliitis or SI joint disruptions. Initial treatment options for patients with SI joint disorders typically involve nonsurgical management and, when non-surgical management of the SI joint fails, surgical options such as the iFuse procedure may be considered.

SI-Bone received original 510(k) clearance in November 2008 from the U.S. Food and Drug Administration for the iFuse implant system. CE mark was obtained in November 2010.