SAN JOSE, Calif., June 13, 2011 /PRNewswire/ -- 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, announced today that it has reached a surgeon training milestone for its iFuse Implant System® with over 400 surgeons trained in the US and in eight countries in Europe. As a result, the medical community's awareness of SI joint dysfunction and optimal surgical treatment options is growing.
From its inception, SI-BONE has been committed to innovation and education in SI joint diagnosis and treatment - of physicians as well as patients. In keeping with that goal, SI-BONE announced that over 400 spine surgeons have been trained to date in the use of the iFuse for MIS SI joint fusion and the Company expects to train an additional 400 surgeons in the next twelve (12) months. The Company is currently conducting an average of one surgeon-training lab per week with over ten faculty members, including members of the SI-BONE Medical Advisory Board, leading these specialized sessions. Training includes a half-day of didactic lecture followed by hands on cadaveric procedures.
The MIS iFuse Implant System is comprised of titanium implants coated with a porous plasma spray acting as an interference surface fit, to decrease implant motion. By providing immediate post-operative fixation, iFuse accomplishes the goal of traditional open SI joint fusion through an MIS approach. The iFuse system does not require joint preparation, which can be very difficult for surgeons to perform on this multi-planar, irregular shaped joint. The iFuse requires no bone harvesting from the iliac crest, like virtually all other systems, which often causes long-term pain and complications. Nor does iFuse require the use of BMP, which is expensive and off-label for the SI joint. Recent clinical publications, including Liliang and DePalma, Pain Medicine 2011, have identified the SI joint as a pain generator in up to 30% of low back pain and in 40 to 61% of post-lumbar fusion patients, so-called 'failed back surgery' patients. Effective treatment of the SI joint is a significant unmet clinical need and, when conservative therapy fails, iFuse may provide an MIS option.
Jeffrey Dunn, President and CEO of SI-BONE, commented, "We are pleased with the significant surgeon adoption of the iFuse Implant System across the US and the EU. Surgeons who are using the iFuse benefit from the potential to improve patient outcomes by providing an enhanced ability for immediate stabilization of the SI joint with a unique MIS approach to SI joint fusion. Early retrospective data indicate patients may be experiencing significant quality of life improvements as a result of treatment with iFuse."
John Glaser, M.D. professor of orthopedic and spine surgery at MUSC in Charleston, SC, responded, "In my experience, the iFuse represents an MIS alternative to traditional open SI joint fusion for patients not responding to conservative therapy. The iFuse procedure may also help treat post-lumbar fusion surgery patients who experience significant SI joint complaints following lumbar surgery. By providing stability, after healing, with minimal dissection, iFuse allows my patients the opportunity to resume normal daily activities."
Mark Reiley, M.D. Chief Medical Officer and Founder of SI-BONE, indicated, "The iFuse provides referring healthcare providers an MIS opportunity to treat a significant percentage of SI joint patients that are unresponsive to non-operative therapies. Through our training programs, we are making a significant contribution to spine surgery by providing new treatment options for SI joint patients and providing surgeons with new practice opportunities."
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 fixation, accomplishing the goal of traditional open SI joint fusion through an MIS approach. Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients and that up to 75% of post-lumbar fusion patients develop SI joint degeneration within five years of surgery. These represent significant unmet clinical needs where iFuse may provide an MIS option.
In response to increasing awareness of SI joint disruption and dysfunction as debilitating symptom generators, SI-BONE, Inc. developed an innovative, patented, intramedullary 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.
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.
|SOURCE SI-BONE, Inc.|
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