SAN JOSE, Calif., Aug. 9, 2011 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company with a surgical solution for treating the sacroiliac (SI) joint, announced today that it has initiated a retrospective clinical study at high volume clinical sites in the U.S. as part of its key corporate initiative to achieve a robust body of clinical and economic evidence for its iFuse Implant System®. The retrospective clinical study is designed to assist in the validation of results received from MISSION (Minimally Invasive Surgical iFuse Implant System in SI Joint FusiON), the Investigational Device Exemption (IDE) study recently filed with the FDA.
This clinical study will be conducted according to a prospective research protocol following approval of a central and local Institutional Review Board (IRB), as required. Data collected will examine clinical and economic outcomes in patients who have been followed up to two years post surgery and who were treated with iFuse for SI joint fusion, along with outcomes reported in patients who received alternative methods of surgical fusion. The data collected on alternative surgical treatments will be used as a comparator for analysis. The first analysis and report of this data is expected to be completed in December 2011. Retrospective studies in conjunction with other clinical research projects will serve to validate the fusion properties of iFuse and the subsequent impact on patient clinical outcomes and quality of life.
Jeffrey Dunn, President and CEO, stated, "Our multi-focal clinical strategy aims to increase awareness of appropriate SI joint diagnosis and surgical options for patients with SI joint dysfunction. SI-BONE is launching post-market retrospective clinical studies that will collect clinical and economic outcomes in patients who have previously been treated with iFuse. Early clinical evidence confirms existing published clinical data indicating that the SI joint is a significant pain generator in patients living with chronic low back pain (LBP). Based on our early experience, it appears iFuse will have a role in helping to address and improve the lives of patients suffering from chronic LBP due to SI joint dysfunction."
Fred Geisler, M.D., noted neurosurgeon specializing in spine surgery at Swedish Hospital in Chicago, IL, reported, "in my experience, the iFuse represents an alternative to traditional SI joint fusion for patients not responding to conservative therapy. The iFuse procedure may also help stabilize an incompetent SI joint, which SI joint injections and other non-surgical treatments do not do. The iFuse allows my patients to have improved function and decreased pain, with some resuming normal daily activities. These good clinical results are provided by the immediate stability obtained in a true minimally invasive surgery."
SI-BONE is focused on innovation and education in SI joint diagnosis and treatment. In support of this, SI-BONE is embarking on a series of major clinical research and development initiatives on the iFuse for SI joint fusion. As part of its clinical strategy, the Company is currently conducting other research initiatives, including MISSION, SI joint diagnosis programs, and preclinical examination of animal healing models with emphasis on imaging and histology.
SI-BONE received 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 provides immediate post-operative stabilization and accomplishes the goal of traditional SI joint fusion through an MIS approach. Clinical publications(1), (2) have identified the SI joint as a pain generator in up to 22 percent of low back pain patients and in 43-61% of post-lumbar fusion patients. Effective treatment of the SI joint is a significant unmet clinical need and, when conservative therapy fails, iFuse may provide an option.
The iFuse Implant System is a commercially available device in the U.S. intended for treatment of conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The iFuse procedure uses a minimal incision for delivery and implantation of small, titanium implants. The implants are coated with a porous plasma spray that acts as an interference surface, designed to help decrease implant motion. 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 boney structures.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint spine medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to sacroiliac (SI) joint pathology. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of SI Joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices.
(1)Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics 1987;217:266–80.
(2)DePalma, M. Etiology chronic LBP patients having undergone lumbar fusion. Pain Medicine, 2011; 12:732-39.
SOURCE SI-BONE, Inc.