Medacta USA Reports First Use of its MySpine Patient-Matched Technology

Medacta USA, the U.S. subsidiary of Medacta International, a privately held, family-owned maker of joint replacement and spine surgery products, reported the first successful surgeries in the United States using the MySpine Patient-Matched Technology.

MySpine uses Medacta’s 3-D reconstruction and rapid 3-D-printing technologies to produce customized patient-specific surgical guides designed to better help surgeons identify pedicle entry points, screw trajectories, and implant specifications.

MySpine received 510(k) clearance by the U.S. Food & Drug Administration in May, and, according to the company, is the first product available in the United States to produce tailor-made patient-specific guides for the spine vertebrae using proprietary computed tomography (CT) scan algorithms and sophisticated 3-D 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. Medacta’s patient-matched technology also is the basis for Medacta’s MyKnee product line, which has been used in more than 15,000 procedures worldwide, according to the company.

The first two surgeries with MySpine were completed by Samuel S. Jorgenson, M.D. and Richard Manos, M.D., of the Spine Institute of Idaho.

“The MySpine customized placement guides offer a welcome new approach to dealing with the nuances and complexities of a patient’s spinal anatomy,” said Jorgenson.

Manos added: “The customized 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 3-D models. Of 76 implanted pedicle screws, 84 percent of the pedicle screws were completely intrapedicular, 96.1 percent within less than 2-millimeter cortical breech. No screw-related clinical complaints were reported postoperatively, the company reported.

“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 utilizes Medacta’s innovative 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.”

MySpine is indicated as a thoracic and lumbar posterior pedicle-targeting guide for patients requiring spinal fusion between the levels of T1 to L5.

Medacta USA is headquartered in Chicago, Ill. Medacta International is based in Switzerland.