July 14, 2022 – Medtronic announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UNiD™ Spine Analyzer v4.0 planning platform, which includes a new Degen Algorithm for degenerative spine procedures. The algorithm leverages machine learning to help surgeons plan and personalize procedures for patients undergoing lower lumbar spine surgery and predicts spinal compensation mechanisms six months after the operation.
This new update also includes enhancements to the pediatric and adult deformity algorithms predicting compensatory changes to the spine. Medtronic is the first and only company to have FDA cleared predictive models for spine surgery.
The release comes with a new UNiD™ Hub patient-centric platform that enables surgeons to track patients throughout the perioperative care pathway and assess surgical results through long-term radiographic and patient-reported outcomes data collection.
Degenerative spine disease is a common health condition and significant cause of disability for many patients worldwide. The UNiD™ ASI Degen Algorithm helps surgeons achieve spinal alignment by more accurately planning procedures and predicting spinal alignment after six months.
Surgical planning, using the UNiD Spine Analyzer, is especially important for degenerative spine procedures, as studies suggest nearly a third of these degenerative patients have a hidden deformity2. A study suggests that when sagittal alignment is not achieved during these procedures, patients are at 10 times greater risk of experiencing degeneration of discs above or below the level where the operation was performed Moreover a study shows that 62% of patients remained sagittally malaligned after their procedure, which may lead to revision surgery.
This new technology further demonstrates Medtronic’s commitment to offering solutions for all spinal pathologies, including deformity and degenerative conditions. Over time, UNiD ASI technology will continue to evolve as more case data is added and predictive algorithms are further refined to help make spine surgery more predictable for surgeons and patients alike.