SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint reported today that it had significant follow up from spine surgeons attending presentations by thought leading spine surgeons on the SI joint as a pain generator in low back pain (LBP) at both the EuroSpine the North American Spine Society (NASS) annual fall meetings.
Of considerable significance for SI-BONE, was the November 3, debate in the Current Controversies in Spine Surgery symposium in front of 2,500 spine surgeons. This was an important spotlight on the SI joint. The debate featured surgical treatment of the SI joint with Michael Janssen, D.O., Denver, arguing that SI joint pain plays a significant role in the pathology of LBP and that SI joint surgery may sometimes be required. “The percent of patients with LBP with SI joint symptoms is probably much more than most of us think … somewhere around 20% of patients who have LBP symptoms have pain that originated from the SI joint,” according to Dr. Janssen. He reviewed a variety of studies that demonstrated the benefits of appropriate diagnosis and interventions targeting the SI joint. He also cited 90% patient satisfaction in an early study with twelve-month iFuse surgery follow-up. “In some ways, the SI joint is an undertreated anatomical joint that patients have substantial symptoms on, and I think we should focus on the SI joint so we do not miss the subset of patients who tend not to improve,” he said.
The counter opinion was presented by Jens Chapman, MD, Seattle. Dr. Chapman said, “I’ll be the first to say that we cannot ignore the SI joint in cases of tumor, trauma or infection…in post-partum instability, tumor, sacral insufficiency fractures and degenerative joint disease, the SIJ is often overlooked, and in these circumstances intervention is warranted.” However, Dr. Chapman said there are no clearly definitive clinical tests for identifying and evaluating SI joint pain. Bone and CT scans can visualize the SI joint, but imaging remains difficult, and the SI joint remains the “hidden joint” and more effort on understanding SI joint diagnosis is required.
This debate reinforces SI-BONE’s key messaging regarding proper diagnosis of SI joint dysfunction and further demonstrates the need for an MIS solution. Increasingly, there is growing acceptance by surgeons that the SI joint is a significant source of unresolved LBP pain that requires an accurate diagnosis. During NASS, SI-BONE sponsored a SI joint dysfunction diagnostic booth that was well attended. This allowed surgeons an opportunity to interface with experienced clinicians and obtain hands on experience in performing various SI joint provocative testing.
Jeff Dunn, CEO of SI-BONE, said, “We are pleased that such notable thought leaders with significant clinical experience are recognizing our clinical and commercial efforts. It is a major advantage to have access to their expertise to strengthen the position of iFuse as the definitive MIS therapy for LBP patients with SI joint dysfunction unresponsive to conservative therapy. By educating the spine surgery community, we will accomplish our mission of helping SI joint patients worldwide.”
The Company further noted that its EuroSpine Luncheon and NASS Satellite Symposium were exceptionally well attended, with over 250 attendees in Milan and in Chicago. The SI-BONE Satellite Symposium at NASS held on Nov. 2, featured five noted spine surgeons who spoke on SI joint diagnosis and iFuse MIS treatment: Steve Garfin, M.D., University of California, San Diego, David Polly, M.D., University of Minnesota, Bengt Sturesson, M.D., Ängelholm Hospital, Sweden, Frank Phillips, M.D., Midwest Orthopedics at Rush, Chicago, and Ralph Rashbaum, M.D., Texas Back Institute, Plano, TX. The EuroSpine Luncheon, held on Oct. 19, featured William Smith, UNLV, Las Vegas, Frank Phillips, Bengt Sturesson, Mark Reiley and other noted European spine surgeons speaking on SI joint diagnosis and iFuse MIS treatment. There was significant exhibit presence at both meetings, with over 200 spine surgeons visiting its exhibition booth and requesting training or additional information.
Mark Reiley, M.D., founder and Chief Medical Officer of SI-BONE, reported, “many surgeons heard through ‘word of mouth’ about iFuse and the opportunity it represents for their practices. Several noted surgical colleagues spent considerable time at our booth detailing other colleagues on SI joint diagnosis as a significant component of LBP and on the iFuse procedure. We also had an interventional pain physician and physical therapist educating surgeons and their personnel on SI joint provocative testing and injections to clinically identify SI joint patients. Both EuroSpine and NASS will provide SI-BONE with a significant boost to our educational efforts going forward.”
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 have identified the SI joint as a pain generator for up to 22 percent of low back pain patients. In addition, DePalma, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 40 to 61% of post-lumbar fusion patients, so-called ‘failed back surgery’ patients.1 Effective treatment of the SI joint is a significant unmet clinical need and, when conservative therapy fails, iFuse may provide an option.
In response to increasing awareness of SI joint disruption and dysfunction as debilitating symptom generators, SI-BONE, Inc. developed an innovative, patented implant to treat the SI joint. The company is also embarking on a prospective multicenter study to document acute and long-term clinical outcomes in patients who are proven to be refractory to prior therapies.
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 pins or screws used to surgically fix boney structures. This implant technology from SI-BONE has been previously used successfully in well over 1,500 cases of dysfunctional foot joints.
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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 DePalma, M. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine, 2011;12:732-39.