by Elizabeth Hofheinz, M.P.H., M.Ed., October 7, 2019
It was with great fanfare that RTI Surgical rolled out new clinical data at NASS last week. A major announcement was the interim clinical outcomes of the EVoluSIon Clinical Trial for the SImmetrySacroiliac Joint Fusion System. The prospective, multicenter single-arm study is examining SI joint pain reduction in 250 patients; data on 150 patients at 6 months follow-up were released at the meeting.
The four steps of implantation for the SImmetry System are: 1) MI lateral access 2) joint preparation via decortication 3) bone graft placement 4) implant delivery.
The promising results include:
- Mean Visual Analog Scale (VAS) SI joint pain decreasing from 77.2 at baseline to 33.3, a statistically significant reduction in pain of 56%.
- Mean Oswestry Disability Index (ODI) scores improving from 54.1 at baseline to 32.8, a statistically significant and clinically meaningful improvement in disability related to SI joint pain.
- A statistically significant decline in opioid use with 62% of patients reporting taking opioids prior to surgery, and 34% reporting taking opioids post-surgery – a decrease of 45%.
- A decrease in the use of non-opioid pain medications such as NSAIDs, analgesics and steroids.
“The interim EVoluSIon data for 150 patients at six months suggest pain reduction continues to be promising and, most notably, the decrease in opioids and other pain medications points to an emerging differentiator for the SImmetry System,” said Camille Farhat, President and CEO, RTI Surgical.
Another NASS data highlight for RTI was when Dr. Joseph O’Brien, Medical Director of Minimally Invasive Orthopaedic Spine Surgery at the Washington Spine and Scoliosis Institute at OrthoBesthesda in Bethesda, Maryland, presented outcomes from the ENRTUST clinical study. This was a multicenter, post market, retrospective study where researchers collected safety and performance data for patients implanted with the Fortilink-C, -TS, and -L Interbody Fusion (IBF) Systems with TETRAfuse3D Technology. The results indicate that those treated with the Fortilink IBF Systems demonstrated the device is safe and results in improvements in pain.
Farhat told OSN, “Over the last five years, we have tripled the size of our spine business and are continuing to expand via differentiation and scale via avenues such as product development, mergers and acquisitions and clinical data. We are building an exciting future in the spine business.”
While at the meeting, OSN sat down with Steven Cohen, a Communications Business Partner with RTI, to talk about the future of spine for the company. “RTI is increasingly becoming an important player in the spine space. We are strengthening our portfolio with differentiated therapies, including the recent addition of coflex through our acquisition of Paradigm Spine. We are heavily focused on building a strong commercial operating system that incorporates surgeon training, patient education and reimbursement efforts to support the needs of a burgeoning treatment like coflex. In addition, we’re also incredibly proud of our renewed R&D efforts and the recent launch of the CervAlign Anterior Cervical Plate System, an internally developed device with a cover-style locking mechanism and streamlined instrumentation. CEO Camille Farhat has built a transformational strategy based on reducing complexity, driving operational excellence and accelerating the growth of RTI to nearly double the size of our business by 2022.”