By: 3 February 2014

shutterstock_16283035SI-BONE, Inc, a medical device company that pioneered the use of the iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced that the iFuse Implant System has been used in over 10,000 procedures worldwide, utilising over 29,000 iFuse implants.

Adoption of the MIS procedure continues to expand and now over 700 surgeons have performed the iFuse procedure in the US and Canada, as well as 13 European countries, with four additional European countries expected to begin performing cases soon. Minimally invasive SI joint fusion is now considered the standard of care1 for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy. The iFuse Implant System is the only MIS treatment option for which there are published peer-reviewed clinical data that support safety and effectiveness.2

“Ten thousand 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. 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, healthcare professionals and insurers on the benefits of iFuse as a treatment option for these patients,” said Jeffrey Dunn, President and CEO of SI-BONE.

Steven Garfin, MD, Distinguished Professor and Chairman at the Department of Orthopaedic Surgery, UC San Diego, US, said: “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. 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 recognised. 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. I am impressed with the company’s focus on patients.”

The iFuse Implant System is a commercially available device in the US and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.

References:

1International Society for the Advancement of Spine Surgery (ISASS) Consensus Statement, July 2013.

2Graham Smith A, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, Kleiner J, Milan M, Shamie AN.  Open versus Minimally Invasive Sacroiliac Joint Fusion: a Multi-Center Comparison of Perioperative Measures and Clinical Outcomes. Annals of Surgical Innovation and Research. 2013, 7:14

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