FDA Clears Shorter Magec Spinal Rod

Thanks to the 510(k) clearance by the Food and Drug Administration, Ellipse Technologies Inc. will be able to market a second, shorter (70mm) actuator as part of its Magec Spinal Bracing and Distraction System. According to company officials, the Magec system provides an alternative to the traditional treatment regimen for early onset scoliosis care which uses growing rods which require repetitive invasive lengthening surgeries. They note that the Magec system is the only non-invasive, distraction-based system available worldwide for young patients.

The benefit of the shorter actuator implant, say company officials, is that it enables broader application of the Magec system for patients with limited spinal space that is attributed to severe spinal deformities. The device features a 20% reduction in the length of the existing Magec 90 mm actuator, providing surgeons better rod contouring capabilities during surgical procedures. Company officials estimate that the shorter rod may enable a 15-20% increase in the number of patients that may benefit from the Magec system.

“Pediatric spinal deformity surgeons fully recognize the game-changing benefits of the Magec system in eliminating the emotional and painful treatment associated with traditional growing rods, ” said Behrooz Akbarnia, M.D., clinical professor of Orthopedic Surgery at the University of California, San Diego. “As shown by several multicenter studies, distraction-based systems have the advantage of providing superior growth potential over growth-guided options.”

The week that Ellipse received the FDA clearance, the company also marked its 100th Magec surgery since its market introduction in the United States in April 2014.