Less than a week ago Si-Bone told us it had gained endorsement from the UK’s NICE agency. Now Zyga Technology, Inc., another player in the Sacroiliac Joint Fusion surgery space has announced that it will release 24-month results from a study into its own solution.
The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adults with approximately 20 percent of all chronic low back pain deriving from the sacroiliac joint.
Si-Bone and Zyga have their own answers, Si-bone’s approach being the iFuse Implant System, a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. Si-Bone says its iFuse Implant is the only commercially available SI joint fusion device in the United States to have significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits. In fact such is the weight of its clinical evidence base that the UK’s National Institute for Health and Care Excellence (NICE) last week issued its recommendation for MIS SI Joint Fusion Surgery using a Lateral Transarticular Approach. NICE, incidentally, develops guidance and quality standards in health and social care and is a worldwide leader in technology evaluations.
Zyga’s SImmetry system achieves SI joint fusion based on adherence to the priniciple that to achieve long term, solid, bony fusion, the joint must first be decorticated using the company’s proprietary system. This week, Zyga tells us its study, Evaluation of Fusion after Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication, will be presented at the 2017 Annual Meeting of the International Society for Minimally Invasive Spine Surgery (ISASS) in Boca Raton, Fla. This prospective, multi-site study evaluated long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.
The study evaluated 18 patients for radiographic evidence of fusion at 12 and 24 months following SI joint fusion with decortication and bone grafting. A systematic Computed Tomography (CT) review was predefined and performed by independent radiologists blinded to each other’s assessments. Previously-reported results demonstrated a 72 percent reduction in average pain and evidence of bridging bone in 79 percent of patients at 12 months. The evidence will be presented by Dr. William W. Cross III, an orthopedic surgeon at Mayo Clinic in Rochester, Minn.
The Company will also release results of another study: Biomechanical Evaluation of Trans-ilium Sacroiliac Joint Decortication and Fixation with Threaded Implants. This study analyzed the contribution of threaded implants to stability of the SI joint following SI joint fixation and quantified resulting rigidity in the presence of joint decortication. The study was led by Dr. Jonathan Sembrano, an orthopedic surgeon at the University of Minnesota Fairview in Minneapolis, Minn.
W. Carlton Reckling, MD, MBA, Chief Medical Officer and Vice President Medical Affairs at SI-BONE stated; “Use with standard arrangements is the most positive recommendation that NICE can make for an interventional procedure such as MIS SI joint fusion. Standard arrangements means that there is enough high-quality clinical evidence to show that the procedure is effective and safe enough for doctors to consider as a treatment option for appropriate patients.”
Jim Bullock, president and CEO of Zyga Technology commented; “Clinical evidence is the bedrock of market development for innovative surgical technology. While studies have shown that fixation of the SI joint can provide relief for SI joint disorders, there is little data today showing the ability of many SI joint fusion technologies to achieve long-term, solid bony fusion across the joint. Zyga is committed to building the evidence needed to expand access for patients to a minimally invasive procedure built on proven orthopedic principles of fusion. Our 250 patient, prospective, multi-center EVoluSIon study will build on the findings in this study to demonstrate the benefit of a true fusion for long-term relief for patients.”
Source: PR Newswire, Si-bone Inc.