Medical device company Ellipse Technologies has obtained 510(k) approval from the US Food and Drug administration for its shorter 70mm actuator, which is part of the MAGEC (MAGnetic Expansion Control) Spinal Bracing and Distraction System.
The addition of the 70 mm actuator implant extends the application of MAGEC system for patients with limited spinal space attributed to severe spinal deformities.
The system is an alternative to the traditional treatment regimen using growing rods that require repetitive invasive lengthening surgeries for early onset scoliosis care.
With a reduction of 20% in the length against the existing MAGEC 90mm actuator, the new retractor offers surgeons better rod contouring capabilities during surgical procedures.
University of California orthopedic surgery clinical professor Behrooz Akbarnia said the pediatric spinal deformity surgeons fully recognize the benefits of the MAGEC system in eliminating the emotional and painful treatment associated with traditional growing rods.
"Furthermore, as shown by several multicenter studies, distraction-based systems have the advantage of providing superior growth potential over growth-guided options," Akbarnia added.
The company also produces PRECICE limb lengthening system, in addition to the MAGEC system.