Press Release Source: SI-BONE, inc. on Monday December 6, 2010, 4:05 pm EST
SAN JOSE, Calif., Dec. 6, 2010 /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 Ralph F. Rashbaum, MD, Texas Back Institute, has joined its Medical Advisory Board (MAB). Dr. Rashbaum joins noted spine surgeons Steve Garfin, Frank Phillips, Paul Anderson and Nick Shamie, along with SI-BONE founder, mark Reiley, on the SI-BONE MAB.
“The SI joint is a significant cause of low back complaints, including pain and disability,” said Ralph Rashbaum, M.D. “My experience and published clinical research strongly suggest that the SI joint is a significant contributor to low back problems. All spine surgeons should include the SI joint as part of their patient work-up and differential diagnosis of low back complaints. the SI joint should perhaps be one of the first things that surgeons evaluate in patients presenting with low back complaints, and I hope that my work with SI-BONE will help teach and convince many other surgeons the importance of this diagnostic thinking.”
Dr. Rashbaum is a board-certified orthopaedic surgeon with a specialization in spine surgery and co-founder of the Texas Back Institute in Plano, Texas, which is one of the largest spine specialty clinics and spine surgical training schools in the United States. He has significant expertise in diagnosing and treating challenging chronic low back pain patients, many of whom were failed surgery patients, as well as pain mechanisms and the physiological effect of various treatments. Dr. Rashbaum has published numerous articles and book chapters on these topics and devotes time to training others in the evaluation of chronic low back pain patients. After earning his Doctor of Medicine from Chicago Medical School, Dr. Rashbaum completed a spine fellowship with Drs. Richard Rothman and Frederick Simone at Pennsylvania Hospital in Philadelphia. He later co-founded Texas Back Institute in 1977.
Commenting on Dr. Rashbaum’s appointment, Jeff Dunn, President and CEO, said, “Having Dr. Rashbaum as a member of our Medical Advisory Board significantly boosts SI-BONE’s capability in getting the word out on appropriate diagnosis of low back complaints that include the SI joint. In addition, his work with minimally invasive surgical technologies provides us with a unique opportunity to teach many new spine surgeons about the iFuse Implant System™ for SI joint fixation/fusion.”
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 percent of low back pain patients and that up to 75 percent 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 post-market multicenter study to determine its effect over time on SI joint pathology and on symptoms associated with SI joint problems.
The iFuse Implant system is a commercially available device in the United States intended for fracture fixation of large bones and large bone fragments of the pelvis for 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 1,000 cases of dysfunctional foot joints.
About SI-BONE, inc.
SI-BONE, inc. (San Jose, California) is a leading spinal 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.
About Texas Back Institute
Texas Back Institute, one of the largest freestanding multispecialty spine clinics in the United States, was established in 1977 and provides comprehensive medical care for back and neck pain. Texas Back Institute is a back care leader specializing in spinal arthroplasty, minimally invasive spine surgery, degenerative disc disease and spinal deformation. as an academic health care organization, Texas Back Institute has trained hundreds of physicians, scientists and allied health professionals. Its research institution employs state-of-the-art technology and is involved in many clinical trials, including artificial discs. Texas Back Institute’s professional staff includes board-certified spine surgeons, general surgeons, internists, physiatrists, pain specialists, exercise physiologists, and a team of physical and occupational therapists. Texas Back Institute has locations in Denton, Fort Worth, Mansfield, McKinney, Plano, Rockwall, Trophy Club, Wichita Falls, Tyler and Odessa, Texas, and Phoenix and Gilbert, Arizona. For more information, visit texasback.com.