SI-BONE Continues Leadership In Clinical Evidence Transparency Initiative Adding INSITE 2-Year RCT Results To Yale Open Data Access Program
SAN JOSE, Calif., Oct. 5, 2016 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® ("iFuse"), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced it has submitted INSITE (Investigation of Sacroiliac Fusion Treatment - NCT01681004) 2-year randomized controlled trial (RCT) data to Yale University's Open Data Access (YODA) program as part of its ongoing effort to promote data transparency regarding its clinical trials. INSITE is a RCT of MIS SI joint fusion with iFuse compared to non-surgical management. The trial enrolled 148 subjects at 19 centers in the U.S. Earlier this year, SI-BONE initiated a partnership with YODA and released 2 year results from a sister study, SIFI (Sacroiliac Joint Fusion With iFuse Implant System), a prospective multicenter clinical trial of SI joint fusion that included 172 subjects treated at 26 U.S. centers. The goal of the partnership between SI-BONE and YODA is to make data from key clinical trials of sacroiliac joint fusion available to approved researchers to allow secondary analyses of clinical trial data and set a new standard for transparency of clinical evidence in medical devices.
SI-BONE's iFuse is the only SI joint fusion device with a patented triangular profile that resists joint motion and is supported by more than 45 peer-reviewed publications. No other SI joint fusion device has peer-reviewed published evidence supporting safety and effectiveness, and iFuse is the only such device commercially available in the United States with an indication statement that includes claims regarding improved pain, patient function and quality of life.
"Interest in clinical trial data-sharing has increased markedly, with several recent editorials in the New England Journal of Medicine on the topic. SI-BONE welcomes independent analysis of its clinical trial data, as it may shed new light on aspects of the treatment procedure. SI-BONE encourages its colleagues in both industry and academia to share their clinical trial data," said Daniel Cher, MD, Vice President of Clinical Affairs, SI-BONE.
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 creating an interference fit designed to help decrease joint 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 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results). 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. 9734.100516
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SOURCE SI-BONE, Inc.