RTI Surgical showcase clinical data at NASS 2019

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tetrafuse
Series of Fortilink interbody fusion devices featuring TETRAfuse 3D Technology (From top, clockwise: Fortilink-C IBF System, Fortilink-TS IBF System, Fortilink-L IBF System).

RTI Surgical will showcase its body of clinical data at the 34th Annual Meeting of the North American Spine Society Annual Meeting (NASS 2019; 25–28 September, Chicago, USA).

“RTI is proud to not only be a partner of choice for surgeons with our comprehensive line of spine products and differentiated specialty therapies backed by clinical data, but to also be able to showcase our key platforms and growth drivers at NASS 2019,” said Camille Farhat, president and CEO, RTI Surgical. “Over the last five years, we have tripled the size of our spine business as we bolstered our R&D pipeline and accelerated growth across our Existing and Novel Therapies to treat more patients. We are building an exciting future in the spine business.”

Interim clinical outcomes of the EVoluSIon clinical trial for RTI’s SImmetry Sacroiliac Joint Fusion System
RTI has completed enrolment for the EVoluSIon clinical trial evaluating the impact of the SImmetry System on SI joint pain reduction on 250 patients. The company will release interim clinical outcomes in a whitepaper at NASS on 150 patients who have reached their 6-month follow-up. The EVoluSIon study evaluates pain and disability at 12- and 24-month follow-up visits, as well as joint fusion rates. The interim results of 150 patients at 6 months show:

  • Mean Visual Analogue 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 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 Farhat.

Evaluation of the Fortilink IBF Systems with TETRAfuse 3D Technology (ENTRUST) clinical study podium presentation
Joseph O’Brien, medical director of Minimally Invasive Orthopaedic Spine Surgery at the Washington Spine and Scoliosis Institute at OrthoBethesda in Bethesda, USA, will present outcomes from the ENTRUST clinical study on Wednesday, September 25, from 1:06-1:12pm. ENTRUST was a multicentre, postmarket, retrospective study which collected safety and performance data for patients implanted with the Fortilink-C, -TS, and -L Interbody Fusion (IBF) Systems with TETRAfuse 3D Technology. Among the key findings, the analysis of patients treated with the Fortilink IBF Systems demonstrated the device is safe and results in improvements in pain.


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