Si-Bone Reaches Treatment Milestone

San Jose, Calif.-based SI-Bone Inc. has reached a milestone of 4,000 patients implanted with the iFuse Implant System, a minimally invasive surgical device to fuse the sacroiliac (SI) joint. The SI joint is the joint in the bony pelvis between the sacrum and the ilium of the pelvis, which are joined by ligaments. The sacrum supports the spine, and the sacrum is supported by an ilium on each side. In 2013, Bi-Bone officials expect to treat more than 5,000 additional patients.

SI-Bone shared the experience of several patients in recognition of this milestone. The company received some moving feedback from people including veterans of the Afghan war, U.S. Navy doctors, farmers, firefighters, writers, and professional soccer players.

“This soldier was deployed to Afghanistan 2009 and involved in an IED [improvised explosive device] blast Oct. 2009—conservative treatment then … had multilevel lumbar fusion but continued with SI pain,” read one email from a U.S. Army case manager. “[In May 2012] right SI joint fusion with iFuse implants—he is very pleased with the results. I can tell just over the phone (I do long distance case management) his voice now has a lift to it and is looking forward to physical therapy He returns today to light duty—desk job for four hours per day.”

The iFuse implant is made of titanium, coated with a porous plasma spray which acts as an interference surface fit designed to decrease implant motion. In order to remain a minimally invasive treatment to maintain the structural integrity of the surrounding sacroiliac bones, iFuse fusion provides initial post-operative stabilization and occurs over the period of months. According to the company, the implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional pins or screws used to surgically fix bony structures.

SI-Bone received original 510(k) clearance in 2008 from the U.S. Food and Drug Administration for the iFuse Implant System, and an updated clearance in April 2011 for sacroiliac joint fusion for conditions including SI joint disruptions and degenerative sacroiliitis. The CE Mark for European commercialization was obtained in November 2010.

Company officials report that clinical publications identify the SI joint as a pain generator for up to 22 percent of low back pain patients. In addition, a 2011 article in Pain Medicine identified the SI joint as a pain generator in lower back pain in 40 to 61 percent of post-lumbar fusion patients, so-called ‘failed back surgery’ patients. Effective treatment of the SI joint has been classified as a significant unmet clinical need and. Si-Bone hopes to make iFuse an option when non-surgical care fails.

SI-Bone develops tools and products for diagnosing and treating patients with low back issues related to SI joint disorders.