SAN JOSE, Calif., Sept. 10, 2013 /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 to fuse the sacroiliac (SI) joint, announced today that over 8,500 patients have been treated with the iFuse resulting in over 25,000 iFuse implants placed in patients worldwide. The iFuse implant has a unique triangular-shaped profile and is coated with a titanium plasma spray (TPS) porous coating. The TPS coating allows for biological fixation and the implant is designed to stabilize and fuse the SI joint. Since the company was founded in 2009, acceptance and adoption of the iFuse Implant System as a surgical solution for patients suffering from SI joint pain has grown dramatically.
It is estimated that minimally invasive SI joint fusion accounts for nearly 90% of all SI joint fusions currently performed in the U.S.1 and the iFuse Implant System accounts for over 90% of all of these minimally invasive procedures. Over 600 surgeons have performed iFuse procedures in 16 countries around the world and marketing approval is expected in over a dozen additional countries within the next nine months. Published data from a database of 5,319 patients indicates that the rate of serious complications, including revisions, is less than 3.8%.2 In addition, two separate surgeon case series report patients benefit from early clinically significant pain reduction that is sustained out to 12 and 24 months with 82% and 100% surgical outcome satisfaction.3,4 In fact, the iFuse Implant System is the only device used in minimally invasive SI joint fusion for which there is published peer-reviewed clinical safety and effectiveness data.
"Twenty-five thousand implants in just over four years is a significant achievement and it is very gratifying to know that our efforts have helped so many patients. Surgeons, as well as other health care professionals, now have an attractive surgical option to treat SI joint disruptions and degenerative sacroiliitis in patients with a diagnosis of sacroiliac joint pain," said Jeffrey Dunn, President and CEO of SI-BONE.
Dr. Peter Whang, Associate Professor in the Department of Orthopaedics and Rehabilitation at the Yale University School of Medicine, said, "the sacroiliac joint has become an increasingly recognized source of low back pain and should always be considered in the differential diagnosis. With these patients, it is absolutely critical to accurately identify the pain generator and by establishing a correct diagnosis of SI joint-mediated pain, it may be possible to avoid unnecessary procedures and ultimately improve our surgical outcomes. In this selected population, there is a growing body of clinical experience and published literature showing that minimally invasive SI joint fusion is safe and effective for relieving symptoms of axial low back pain."
Dr. Gunnar Andersson, a member of the Board of Directors of the International Society for the Advancement of Spine Surgery (ISASS) also opined by saying, "ISASS recently issued a consensus statement concluding that minimally invasive SI joint fusion should be covered by payors – its time has come and studies are showing that it's safe and effective as well as so much better for the patient. For example, recent data show that blood loss is a tenth of what it used to be with open procedures and the patients do really well."
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant 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.5 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 43%, and may be as high as 61% of post-lumbar fusion, so-called "failed back surgery," patients.6 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. ©2013 SI-BONE, Inc. All Rights Reserved. 8471.060413
1International Society for the Advancement of Spine Surgery (ISASS) Consensus Statement, July 2013.
2Miller LE, Reckling WC, Block JE. Analysis of the postmarket complaints database for the iFuse SI Joint Fusion System: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption. Medical Devices: Evidence and Research. 2013;6:77-84.*
3Rudolf L. Sacroiliac Joint Arthrodesis – MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. The Open Orthopaedics Journal. 2012;6:495-502.*
4Sachs D, Capobianco R. Minimally Invasive Sacroiliac Joint Fusion: One-Year Outcomes in 40 patients. Advances in Orthopedics. 2013;2013:536128. Epub 2013 Aug 13.*
5Bernard TN Jr, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
6DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.
* SI-BONE provided support for this study.
|SOURCE SI-BONE, Inc.|
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