SAN JOSE, Calif., Nov. 5, 2014 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System®, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint will host a symposium during the North American Spine Society (NASS) annual meeting. The symposium on Thursday night, November 13th, from 5:30 to 7:30 pm at the W Hotel, will feature a panel of distinguished speakers who will cover a broad range of topics on the diagnosis and treatment of SI joint disorders. Scott Kitchel, MD,ab of the Neurospine Institute in Eugene, OR will present the underlying anatomic and biomechanical rationale for why the SI joint can be a source of lower back pain. Also, Joseph Fortin, DO,a from the Spine Technology and Rehabilitation Center in Fort Wayne, IN, will discuss his approach on how to properly diagnose the SI joint as a source of low back pain. Peter Whang, MD,ab from the Yale University School of Medicine, will present the existing published clinical evidence supporting MIS SI joint fusion surgery using the iFuse Implant System including the recently published five year results. The symposium is open to all health care professionals attending NASS who have an interest in learning more about the diagnosis and treatment of patients suffering from certain causes of SI joint low back pain.
In addition to the symposium, there will be a number of presentations on MIS SI joint fusion and the iFuse Implant System during the NASS meeting. On Wednesday, November 12th, Leonard Rudolf, MD,abd author of a recently published paper titled “Five-Year Clinical and Radiographic Outcomes after Minimally Invasive Sacroiliac Joint Fusion using Triangular Implants” will present his five year results in the Solution Showcase Theater on the NASS exhibit floor from 12:30 1:00 pm. On Thursday, November 13, Peter Whang, MD, will present a summary of all of the iFuse clinical evidence published to date in the Solution Showcase Theater from 12:00 to 12:30 pm. Also on Thursday, David Polly, MD,c from the University of Minnesota, will present a paper on SI joint burden of disease from 2:22 to 2:28 pm in room 302 and Charles Ledonio, MD,c from the University of Minnesota, will present a paper on comparative effectiveness of open vs MIS SI joint fusion from 2:22 to 2:28 in room 303.
There will also be four ePosters available for viewing during the NASS meeting:
- Safety and Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study
- Minimally Invasive Fusion of the SI joint: A Multi-center Outcomes Study
- Biomechanical Evaluation of a Minimally Invasive Procedure for Sacroiliac Fusion
- How Often is Lumbar Spinal Fusion Performed Prior to Diagnosis of Sacroiliac Joint Disruptions
“The annual NASS meeting brings together spine care professionals from all around the world and provides a great venue to discuss the role of the SI joint as a source of low back pain,” said Jeffrey Dunn, President and CEO of SI-BONE. “The SI joint is now seen by many as the most underserved area of the spine and one that is positioned for significant growth now that there is substantial published clinical evidence. The data is also showing that there are a large number of patients suffering from low back pain who are under-diagnosed or misdiagnosed.”
Clinical publications have identified the SI joint as a pain generator in up to 30% of low back pain patients.1,2,3,4 In addition, the prevalence of SI joint pain in post-lumbar fusion, so called “failed back surgery” patients, has been shown to be 43%.5 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 procedure may provide an option for some 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. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI 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. Physicians should refer to the product labeling for a discussion of these risks and patients should talk with their doctors about these risks before deciding if the iFuse Implant is right for them.
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. 8947.110414
1 Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clinical Orthopedics and Related Research. 1987;217:26680.
2 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:317.
3 Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:188992.
4 Sembrano JN, Polly DW.c How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E2732.
5 DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine. 2011;12:732-9.
Disclosures
aPaid consultant for SI-BONE, Inc.
bConducts clinical research for SI-BONE, Inc.
cConducts clinical research for SI-BONE. No financial interest in SI-BONE, Inc.
dOwnership interst in SI-BONE, Inc.
SOURCE SI-BONE, Inc.
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