Medacta USA has completed the first successful surgeries in the USA utilising MySpine patient-matched technology. MySpine uses Medacta’s 3D-reconstruction and 3D-printing technologies to produce customised patient-specific surgical guides intended to support spinal surgeons during the most complex deformity cases.
Designed to help surgeons identify pedicle entry points, screw trajectories, and implant specifications, MySpine is intended to increase the accuracy, efficiency, and outcomes of spinal procedures.
MySpine received 510(k) clearance from the US Food and Drug Administration (FDA) in May 2014, and is the first product available in the USA that produces patient-specific guides for the spine vertebrae utilising proprietary CT scan algorithms and sophisticated 3D medical printing technology.
Paired with Medacta’s M.U.S.T. pedicle screw system, MySpine supports spine surgeons during the critical steps of pedicle screw placement by offering the potential for improved accuracy, as well as reduced surgical time and radiation exposure.
The first two surgeries with MySpine were completed by Samuel S Jorgenson and Richard Manos of the Spine Institute of Idaho. Manos observes: “The customised pre-operative process provides a high level of precision and accuracy. This cuts down on the overall time of the procedure, and will help us deliver more efficient care to the multiple patients we see each day with challenging spinal cases.”
The MySpine clinical experience was most recently detailed in a study published in the Journal of Spinal Disorders and Techniques, which tracked results from four patients with severe scoliosis whose navigational templates and placement guides were manufactured using MySpine’s CT-based 3D models. Of 76 implanted pedicle screws, 84% of the pedicle screws were completely intrapedicular, with 96% within less than 2mm cortical breech. No screw-related clinical complaints were reported postoperatively.
“The pedicle screw is one of the spine surgeon’s most commonly used tools, but its widespread prevalence doesn’t make its proper placement any less challenging. The practice remains technically demanding, with a very small margin of error,” said Francesco Siccardi, executive vice president, Medacta International. “MySpine utilises Medacta’s patient-matched technology to create pedicle screw placement guides unique to the patient, giving surgeons added confidence and support that can increase procedural efficiencies, improve outcomes, and contribute to healthcare sustainability.”