IRVINE, CA--(Marketwired - March 06, 2014) - Ellipse Technologies, Inc., a global medical device company, announced today that it has received FDA 510(k) clearance to market the MAGEC® (MAGnetic Expansion Control) Spinal Bracing and Distraction System. The MAGEC system is now available for use in skeletally immature patients less than 10 years of age with severe progressive spinal deformities associated with, or at risk of, Thoracic Insufficiency Syndrome.
Traditional growing rods provide a growth-friendly solution to treat these spinal deformities, but require repeated lengthening surgeries, typically every six months, throughout the child's growing years. The MAGEC system provides a revolutionary alternative to this emotionally and physically painful treatment regimen. Its non-invasive lengthening technology eliminates the need for repeat lengthening surgeries, resulting in significant socioeconomic benefits to the patients and their families.
To date, the MAGEC system has been used by more than 150 surgeons in 24 countries in the surgical treatment of more than 750 children. Ellipse has been working collaboratively with the FDA to make this device available for use in the United States. Ed Roschak, President and CEO of Ellipse Technologies, stated, "FDA clearance of the MAGEC system is a significant milestone, and we are excited about the opportunity to make this preferred surgical option available to children in the United States."
Behrooz Akbarnia, M.D., Past President of the Scoliosis Research Society and a world-renowned pioneer in advanced treatments for scoliosis in young children said, "The early performance of the MAGEC system has been studied and presented in numerous peer-reviewed publications. The benefits of non-invasive, distractions compared to repeated open lengthening surgeries are clearly compelling." Dr. Akbarnia added "Now, we have the opportunity to offer this surgical treatment option to patients and families in the United States."
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.
The following files are available for download: