RTI Surgical® Releases Data on the SImmetry® System Showing 98% of Treated SI Joints Demonstrate Evidence of Fusion
Interim results in the EVoluSIon Study on the SImmetry® System further show 78 percent of patients are opioid-free at 24 months
DEERFIELD, Ill., Feb. 26, 2020 (GLOBE NEWSWIRE) -- RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical implant company, will showcase its expanding body of clinical data on the SImmetry® Sacroiliac Joint Fusion System at the 2020 International Society for the Advancement of Spine Surgery (ISASS) meeting in San Juan, Puerto Rico, from February 26-28. The interim results on 50 patients at 24 months in the EVoluSIon study indicate 98 percent of treated joints show evidence of fusion and 78 percent of patients are opioid-free, reinforcing the importance of decortication as part of the SImmetry System procedure to drive fusion and pain relief for patients with SI joint dysfunction.
“In my experience using the SImmetry System, I have observed it follows true orthopedic principles for fusion with decortication, bone grafting and fixation,” said Dr. Donald Kucharzyk of DK Orthopedics in Crown Point, Indiana. “It is reproducible and consistent in its technique case after case, even with anatomic variations. Patients feel the difference immediately. These interim EVoluSIon study results reveal a significant reduction in opioid use from baseline, significant improvements in activity levels, and compared to the previous literature published, compelling evidence of fusion.”
Latest Interim Clinical Outcomes in the EVoluSIon Study
RTI will release interim clinical outcomes on 50 patients who have reached their 24-month follow-up in the EVoluSIon study through a podium presentation, “Clinical and Radiographic Outcomes Following Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication,” on February 26 from 2:20 - 2:25 p.m. in Room 208 by Dr. Donald Kucharzyk.
The interim results of 50 patients at 24 monthsi show:
- 98% of treated joints with evidence of fusion, with 84% showing solid fusion and 14% showing possible fusion. Solid fusion was defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.
- A statistically significant decline in opioid use of 65% from baseline, with 78% of patients opioid-free at 24 months.
- Mean Visual Analog Scale (VAS) SI joint pain decreasing from 75.2 at baseline to 30.1, a statistically significant reduction in pain of 60%.
- Mean Oswestry Disability Index (ODI) scores improving from 55.2 at baseline to 26.9, a statistically significant reduction of 51% and clinically meaningful improvement in disability related to SI joint pain.
“Interim EVoluSIon study data continue to show that joint decortication as part of the SImmetry System helps to achieve real fusion, which supports reduced opioid use and significant pain relief,” said Camille Farhat, President and CEO, RTI Surgical. “As we progress toward our future as a more focused spine company, RTI is committed to offering surgeons a growing portfolio of differentiated clinical solutions and therapies backed by data to deliver better outcomes for patients.”
The EVoluSIon study will continue to evaluate pain and disability at 12- and 24-month follow-up visits, as well as joint fusion rates, which is expected to define similarities or further distinctions between different types of implants for the SI joint.
RTI will also feature its Established Therapies spine products and differentiated Novel Therapies at booth #400, including portfolio growth-drivers TETRAfuse® 3D Technology, ViBone® Viable Bone Matrix, coflex® Interlaminar Stabilization® and the SImmetry System. The Company will also host a Lunch Workshop with Dr. Scott Blumenthal, Texas Back Institute, Dallas, Texas, Dr. Celeste Abjornson, Hospital for Special Surgery, New York, New York, and Dr. Donald Kucharzyk. Titled “The Role of Differentiated Technologies in the Spine Surgeon's Practice,” the workshop will take place Thursday, February 27, from noon to 1:30 p.m. in Room 209B.
References
i Data on file with RTI Surgical
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About RTI Surgical Holdings, Inc.
RTI Surgical Holdings is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, plastic surgery, spine, orthopedic and trauma procedures and are distributed in over 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit . Connect with us on and .
Forward-Looking Statements
Portions of this document may constitute “forward-looking statements” as defined by federal law. Although the company believes any such statements are based on reasonable assumptions, there is no assurance that actual outcomes will not be materially different. Any such statements are made in reliance on the “safe harbor” protections provided under the Private Securities Reform Act of 1995. Additional information about issues that could lead to material changes in performance is contained in the company’s annual and quarterly reports filed with the Securities and Exchange Commission.
