ALISO VIEJO, Calif.--(BUSINESS WIRE)--Ellipse Technologies, Inc., a global medical device company, announced today that it has received FDA 510(k) clearance to market its next generation external remote controller (“ERC 2”) for use with the MAGEC (MAGnetic Expansion Control) Spinal Bracing and Distraction System. The ERC 2 provides improved ergonomic handling and greatly enhanced user interfaces over the first generation ERC.
The MAGEC system consists of magnetic spinal rods and the ERC 2. It is the only non-invasive distraction technology available for the treatment of early onset scoliosis (EOS). The game-changing MAGEC system eliminates painful repeated surgeries for distractions, typically performed every six months, which are required by other EOS treatment options.
Through remote control, the MAGEC device can be non-invasively distracted in seconds in a precise, controlled manner after the initial implantation. This system enables a superior surgical technique advancement that is being widely adopted by surgeons who treat children with EOS.
The elimination of repeated surgical distractions drastically reduces hospitalization, neuro-monitoring, anesthesia exposure, and the incidence of infection, enabling better outcomes for these children and providing overall cost savings in their treatment.
The MAGEC system is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities associated with or at risk of Thoracic Insufficiency Syndrome. To date, the MAGEC system has been used in approximately 300 procedures in the United States and 1500 procedures worldwide.
The MAGEC system is on display this week at the Ellipse Technologies booth at the 2015 Pediatric Orthopaedic Society of North America Annual Meeting in Atlanta, Georgia.
About Ellipse Technologies
Ellipse Technologies, Inc. is a privately held medical device company located in Irvine, California. The company is dedicated to the design, development, and commercialization of its evolving proprietary technology platform for orthopedic and spinal applications. This technology enables precisely controlled, non-invasive post-operative adjustment of implants allowing surgeons to better address a range of clinical needs. In addition to the MAGEC® system, Ellipse markets the PRECICE® limb lengthening system. Ellipse is developing additional products to significantly improve clinical outcomes in a variety of applications through its collaboration with surgeon thought leaders. For more information, visit www.ellipse-tech.com.