SAN JOSE, Calif., July 18, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of the 40th peer-reviewed paper on SI joint fusion with iFuse. The paper, titled Durable intermediate to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants, shows mean 3.7-year follow-up for minimally invasive SI joint fusion was associated with improved pain, low disability scores, improved ability to perform activities of daily living and low revision rates.
The study was a multicenter retrospective cohort study with a prospective evaluation component that included 107 patients at 7 centers in the United States, each with a single surgeon. SI joint diagnosis was determined at all sites on the basis of typical history, physical examination findings and a confirmatory diagnostic anesthetic block of the SI joint producing acute pain relief of ≥50%. Mean SI joint pain at baseline was 7.5. At mean follow-up of 3.7 years (range 3.0 – 4.7 yrs.), the mean SI joint pain score was 2.6, a 4.8-point improvement. Mean ODI at follow-up was 28.2, a value strikingly similar to that reported at 2 years in prospective clinical trials of SI joint fusion1. SI joint revision surgery was uncommon, occurring in 5 patients (4.7%), which is identical to previously reported 2-year results from a prospective multicenter clinical trial of SI joint fusion with iFuse – SIFI (Sacroiliac Joint Fusion with iFuse Implant System)1.
“Results from this study with 3.7 years follow-up are consistent with previously reported prospective trials and demonstrate that iFuse provides a durable surgical solution for appropriately selected patients suffering from SI joint dysfunction due to SI joint disruption or degenerative sacroiliitis in real world practice settings,” said Donald Sachs, M.D., lead author on the paper.
“NASS has always been a champion of evidence-based medicine,” said Eric J. Muehlbauer, MJ, CAE, Executive Director of the North American Spine Society (NASS). “To best help patients who are coping with debilitating spine pain, including certain SI joint disorders, it is critical that we all continue to contribute to the growing body of scientific literature on diagnosis, treatment and prevention strategies. We commend SI-BONE for its data driven approach.”
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for the SI joint. 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 with a porous surface that acts as an interference surface, designed to help decrease implant motion, and allow for biological fixation to support long term fusion. iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 40 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse. It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9574.071816
1 Duhon BS, Bitan F, Lockstadt H, Kovalsky DA, Cher DJ, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-year Follow-up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13.
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SOURCE SI-BONE, Inc.
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