21 Jul, 2020, 09:00 ET
TAMPA, Fla., July 21, 2020 /PRNewswire/ -- Advancing a new era of treating sacroiliac (SI) joint pain with minimally invasive treatment, PainTEQ, in partnership with Evolve Restorative Center in Santa Rosa, Calif. and Celeri Health in Wilmington, Del., is leading a single-arm multicenter, prospective study exploring sacroiliac joint fusion using a posterior approach.
The study is actively enrolling patients who have been treated using the LinQ™ Sacroiliac Joint Fusion System, a possible new standard of care for people with chronic SI joint pain where appropriate non-surgical treatment has failed. LinQ is a treatment option that is less invasive than traditional sacroiliac fusion procedures.
Nine centers are actively enrolling in the Single-arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device (SECURE) Study. Prior research suggests the SI joint represents the source of pain for up to 30 percent of people with chronic lower back pain.
"This landmark study represents the first prospective data acquired, in a multicenter fashion, on a posterior fusion approach for the treatment of sacroiliac joint dysfunction," said Co-Primary Investigator on the SECURE Study, Jason E. Pope, MD, Chairman of the Pacific Spine and Pain Society and President of Evolve Restorative Center in Santa Rosa, California.
"I'm hopeful, once completed, our data will help support the millions of people living with the burden of SI joint pain with a patient centric, minimally invasive treatment grounded in evidence and driven by endpoints of best in class safety and efficacy," said Dawood Sayed, MD, Co-Primary Investigator, President of The American Society of Pain and Neuroscience, and Associate Professor of Anesthesiology and Pain Medicine at The University of Kansas Health System in Kansas City, Kan.
Patrick Buchanan, MD, of Spanish Hills Interventional Pain Management in Camarillo, Calif, enrolled the first patient into this pivotal study in June 2020. Study participants will be tracked over the course of a year to determine the long-term benefits of the LinQ system.
"It's a safer procedure by going posteriorly, which has led to quicker post-op recovery times and better patient outcomes," said Buchanan. "My first patient reports 80 percent pain relief. Prior to the SI joint fusion, he was only able to walk 10 minutes at a time. Now he is walking one-and-a-half to two miles a day."
"I'm excited to see that the study results are commensurate with what I'm seeing in my practice," said Jeff Henn, MD, Neurosurgeon from Joint Implant Surgeons of Fort Myers, Fla. and a Member of the PainTEQ Scientific Advisory Board. "I think it's a great procedure for the interventional pain physician as they typically treat many patients suffering from SI joint dysfunction. The percutaneous nature of the procedure fits the expertise and risk profile of the specialty."
About PainTEQ: Built to bring interventional procedures to market, PainTEQ is a medical device innovator headquartered in Tampa, Florida. Working with pain management specialists to safely reduce and eliminate sacroiliac (SI) joint dysfunction, PainTEQ's LinQ therapy is immediately providing clinical benefits to individuals living with incapacitating lower back pain, through a minimally invasive, outpatient procedure.
About LinQ: The LinQ SI Joint Stabilization System provides SI joint dysfunction patients with a safe, minimally invasive solution to combat pain. After a thorough diagnostic process, physicians can help alleviate, and in many cases eliminate, chronic pain by placing a single LinQ allograft into the SI Joint. This single implant helps patients immediately regain joint stability – and with its large graft window, the LinQ SI Joint Stabilization System helps create an ideal environment for long-term fusion. Learn more at PainTEQ.com.
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