Ellipse Technologies, Inc.’s Magnetic Expansion Control Spinal Bracing and Distraction System (MAGEC) received FDA 510(k) clearance in February and now, for the first time since being cleared for commercial sale has been used to treat a young patient with progressive spinal deformity. Patrick J. Cahill, M.D., and Harold van Bosse, M.D. performed the surgery at Shriners Hospitals for Children, Philadelphia.
The MAGEC system, which won the Orthopedics This Week Spine Technology Award for 1 of the 10 best new spine technologies in 2011, is for use in skeletally immature patients less than 10 years of age with severe spinal deformities associated with, or at risk of thoracic insufficiency syndrome. According to the manufacturer, the system provides an alternative to traditional growing rods which require repeated lengthening surgeries throughout a child’s years of growing. MAGEC’s non-invasive lengthening procedure eliminates the need for repeated lengthening surgeries.
“The MAGEC system is a game changer in early onset scoliosis care, ” said Cahill, regarding the case. “I expect that it will decrease the number of surgeries these young patients have to undergo. The decrease in surgeries will translate into decreased complication rates and cost.”
Ellipse Technologies is a privately-held medical device company located in Irvine, California. Company officials report that the MAGEC system has been used by more than 150 surgeons in 24 countries in the surgical treatment of more than 750 children. Pediatric deformity surgeon, Behrooz A. Akbarnia, M.D., performed the first two cases in the United States, prior to the FDA clearance, under the FDA’s compassionate use provision in May of 2013.
