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CHATTANOOGA, Tenn. , June 29, 2022 /PRNewswire/ — 3Spine, Inc. , a medical device company approaching general lumbar spine joint replacement, today announced the final touch of the first series of surgical procedures in the United States with balancedBack’s total joint replacement experimental clinical trial (IDE). All patients enrolled in the IDE will obtain the MOTUS device and their propensity will be compared to patients prospectively enrolled in 3Spine’s Real World Evidence Fusion (RWE) adaptive statistical design. RWE examine has been enrolling in the U. S. from May 2021.
Benjamin Geddes, MD performed the surgeries at the Center for Sports Medicine and Orthopedic Surgery in Chattanooga, TN, with the assistance of Alex Sielatycki, MD of the Steamboat Orthopaedic and Spine Institute and UC Health Yampa Valley Medical Center in Steamboat Springs, CO. “Alex and I am revered to have the honor of performing the first total lumbar arthroplasty in the United States,” said Dr. Geddes. “The procedures were very bien. se had undergone a hip and knee replacement. This is an encouraging start and we look towards additional recruitment. “
Jeff Goldstein, MD, National Principal Investigator (PI) at THE IDE, said, “On behalf of our principal investigators across the country, I would like to congratulate Dr. Geddes for being the first site to complete RWE exam recruitment, making it historic work. Dom Coric, MD, national principal investigator for the RWE exam, continued, “Our strategy of first collecting real-world evidence on a variety of posterior lumbar fusions works well, offering a vital baseline on site and allowing for a staggered start of the IDE across all centers. I echo Jeff to congratulate Alex and Ben on their success. »
3Spine’s MOTUS device, the implant used in the BalancedBack general joint replacement procedure, is a “first-of-its-kind” generation that replaces the disc portion and lateral joints with a posterior approach. The goal of the procedure is to treat leg pain, back pain, and spinal instability in general, while correcting posture and restoring freedom of movement through reconstruction of the serv asal vertebral unit. 3 The spine is looking for single-point indications of L1-S1 in patients with lumbar degeneration with or without recessive spinal stenosis with no more than grade 1 spondylolisthesis at the applicable point. Additional main points can be found in ClinicalTrials. gov.
About 3Spine
3Spine is a new healthcare company founded to integrate progression, clinical studies, and the source of lumbar joint prostheses in general. 3Spine is headquartered in Chattanooga, TN, with studies and progression services in the Greater Boston domain and clinical operations in the Cayman Islands. www. 3spine. com
Media ContactChristopher Chafin, SweeneyVesty New Yorkchris. chafin@sweeneyvesty. comTel 718 530 4135
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SOURCE 3Brain column