3Spine announced today that it received FDA investigational device exemption (IDE) for its Motus spinal implant device.
Chattanooga, Tennessee-based 3Spine designed the Motus device for use in the BalancedBack total joint replacement procedure.
3Spine’s BalancedBack procedure is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1 for skeletally mature patients due to symptomatic lumbar degeneration with or without foraminal or recess spinal stenosis confirmed by radiographic imaging (CT, MRI, X-rays), with no more than a Grade 1 spondylolisthesis at the involved level.
The first-of-its-kind Motus technology replaces the function of the disc and facet joints through a posterior approach, broadly addressing leg pain, back pain and spinal instability while correcting posture and restoring freedom of movement through the reconstruction of the functional spinal unit.
Motus received FDA breakthrough device designation in 2020, according to a news release.
“Breakthrough device designation was critical to our success in the IDE approval process,” 3Spine CEO Ron Yarbrough said in the release. “This project is the culmination of decades of technical and clinical research in the lumbar spine, and while the courage of pioneering patients and surgeons brought us to this point, today it is all about the tenacity and expertise of the FDA review team.
“Our interactive review with FDA over the past two years has resulted in comprehensive coverage of an unparalleled number of technical disciplines, reflecting the potentially transformational nature of this spine technology. We are very excited to begin IDE enrollment.”
3Spine will conduct a U.S. pivotal clinical trial for Motus, having previously completed contracting and site initiation at 16 U.S. centers for a prospective real-world evidence fusion study that has been enrolling patients since May 2021.
As sites complete the enrollment for their real-world evidence cohort, each center becomes eligible to participate in the IDE study, which will enroll approximately 150 real-world patients to propensity match with approximately 150 IDE patients in an adaptive statistical design.
MCRA has supported 3Spine through the study design and IDE approval processes, the company said.
“This is important, breakthrough technology for an underserved patient population,” said Justin Eggleton, Vice President of Spine Regulatory Affairs at MCRA. “The considerations for such a novel treatment required significant resources at FDA, and we appreciate the agency’s dedication to the review. The FDA review team carefully and thoughtfully challenged over 10,000 pages of biomechanical data, clinical history, and an exhaustive battery of non-clinical testing. FDA’s review establishes an important foundation for our project. MCRA is excited to partner with 3Spine as CRO for the IDE to strengthen the safety and effectiveness profile for our future pre-market approval application.”