IRVINE, Calif.–(BUSINESS WIRE)–Ellipse Technologies, Inc., a global medical device company, announced today that for the first time since gaining FDA 510(k) Clearance, the MAGEC (MAGnetic Expansion Control) Spinal Bracing and Distraction System was successfully implanted in a young patient with progressive spinal deformity by Drs. Patrick J. Cahill and Harold van Bosse at Shriners Hospitals for Children® — Philadelphia last week.
“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.”
The MAGEC system was cleared by the FDA on February 27th 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.
Used as an alternative to traditional growing rods which require repeated lengthening surgeries throughout the child’s growing years, the MAGEC system provides a revolutionary alternative to this emotionally and physically painful treatment regimen. The non-invasive lengthening procedure eliminates the need for repeated lengthening surgeries resulting in significant health, psychological and socioeconomic benefits for the patients and their families.
“The MAGEC system is a game changer in early onset scoliosis care,” said Dr, Cahill, regarding the historic 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.”
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. In addition, the first two cases in the United States prior to the FDA clearance were performed, under the FDA’s compassionate use provision, in May of 2013 by pediatric deformity surgeon, Dr. Behrooz A. Akbarnia.
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.
About Shriners Hospitals for Children
Shriners Hospitals for Children is changing lives every day through innovative pediatric specialty care, world-class research and outstanding medical education. Our 22 facilities, located in the United States, Canada and Mexico, provide advanced care for children with orthopaedic conditions, burns, spinal cord injuries, and cleft lip and palate. Shriners Hospitals for Children is a 501(c)(3) nonprofit organization and relies on the generosity of donors. All donations are tax deductible to the fullest extent permitted by law.
Paul Williams, 310-569-0023