SI-Bone Celebrates Milestone for Sacroiliac Fusion Device

San Jose, Calif.-based SI Bone Inc. is celebrating the 10,000th procedure performed with its iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint. In these 10,000 procedures worldwide, approximately 29,000 implants have been used.

According to the medical device company, adoption of the MIS procedure continues to expand and now over 700 surgeons have performed the iFuse procedure in the United States and Canada as well as 13 European countries with 4 additional European countries expected to begin performing cases soon.

Minimally invasive SI joint fusion is now considered the standard of care for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy.

The iFuse received original 510(k) clearance from the U.S. Food and Drug Administration in November 2008, when it was known as the SI Joint Fusion System. The clearance was for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, but an additional clearance in April 2011 expanded the device’s indication for SI joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.

“10,000 procedures is truly a significant milestone for us to achieve and it is very gratifying to know that our technology has helped so many people,” said Jeffrey Dunn, President and CEO of SI-Bone. “However, in spite of this significant achievement, we believe there are many more patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who have failed conservative therapy and we will continue to accelerate our leadership efforts to educate patients, health care professionals and insurers on the benefits of iFuse as a treatment option for these patients.”

“A little over four years ago, when I first learned about SI-Bone and the iFuse procedure, I was intrigued and thought this would potentially be something useful but only for a very limited number of patients,” said Steven Garfin, M.D., distinguished professor and chairman of the department of orthopedic surgery at the University of California San Diego. “However, after a little over four years now and over 10,000 procedures, it is obvious that the SI joint disorders that are treatable with the iFuse are much more prevalent than previously recognized. SI-Bone has pioneered this new approach to treating the SI joint and the iFuse is the only MIS device that has published clinical safety and effectiveness evidence to support its use.”