San Jose, California, January 6, 2014 / PRNewswire / --
SI-BONE, Inc. (San Jose, California), 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 today that the iFuse Implant System has been used in over 10,000 procedures worldwide utilizing 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 U.S. 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 care1 for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy, and the iFuse, with its unique triangular-shape and porous titanium plasma spray (TPS) coating, is the clear market leader. In addition, the iFuse Implant System is the only MIS treatment option for which there are published peer-reviewed clinical data that support safety and effectiveness.
“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. 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,” said Jeffrey Dunn, President and CEO of SI-BONE.
Steven Garfin, MD, Distinguished Professor and Chairman, Department of Orthopedic Surgery, UC San Diego, 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 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. I am impressed with the company’s focus on patients.”
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the “SI Joint Fusion System”) for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients.3 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator from 43% to 61% of post-lumbar fusion, so-called “failed back surgery,” patients.4 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
The iFuse Implant System is a commercially available device in the U.S. 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.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved.
1 International Society for the Advancement of Spine Surgery (ISASS) Consensus Statement, July 2013.
2 Graham 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
2 Duhon BS, Cher DJ, Wine KD, Lockstadt H, Kovalsky D, Soo CL. Safety and Six-Month Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Medical Devices: Evidence and Research. 2013;6:219-29
3 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
4 DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.
Dr. Garfin, Dr. Graham Smith, Dr. Rudolf, Dr. Sachs, Dr. Gundanna, Dr. Shamie and Dr. Duhon are paid consultants for SI-BONE. Dr. Rudolf, Dr. Sachs, Dr. Gundanna, Dr. Duhon, Dr. Lockstadt, Dr. Kovalsky and Dr. Soo are paid clinical research investigators for SI-BONE. Dr. Garfin, Dr. Rudolf and Dr. Shamie have an ownership interest in SI-BONE. R. Capobianco, Dr. Cher, and K. Wine are employees of SI-BONE.