IRVINE, Calif.–(BUSINESS WIRE)–Ellipse Technologies, Inc. (“Ellipse”) announced today it has received CE Mark (Conformité Européenne) for its MAGECTM Technology for the treatment of spinal deformity. The first application for this technology is for the treatment of spinal scoliosis in young children and teenagers. The CE Mark allows the Company to market the MAGEC System in the European Union and other countries that recognize the CE Mark for commercial distribution purposes.
Ellipse has developed the MAGEC (MAGnetic Expansion Control) Technology for minimally invasive, and ultimately, non-invasive, orthopedic deformity prevention and management. Ellipse has filed numerous patent applications for the use of the MAGEC Technology for a broad range of clinical applications. The Company is currently concentrating on spinal and orthopedic trauma applications. MAGEC Technology is a breakthrough medical device technology capable of non-invasively adjusting implants within the human body from outside the body via remote control.
Currently, young children, pre-teenagers and teenagers with spinal scoliosis have few medical options. The standard treatment requires a series of five to ten highly invasive surgical operations with large surgical incisions and long recovery times performed over a number of years – a process so undesirable that 67% of the diagnosed patients refuse the surgical option.
With the MAGEC Technology, a single minimally invasive surgical procedure is completed. Then, during a series of simple outpatient visits, the physician will dynamically adjust the MAGEC Technology from outside the body via the MAGEC System’s control unit, thus eliminating the need for multiple highly invasive surgical procedures. The MAGEC System is designed to provide for spinal motion preservation, no long term permanent implant, and minimal trauma and scarring.
Commenting on the European regulatory approval, Ellipse Chairman, Michael Henson said, “Ellipse hopes to revolutionize the treatment of scoliosis and offer corrective therapy to a broader population in need, consisting of both young and older scoliosis patients. We plan a worldwide study in the top clinical centers to progress simultaneously with a limited market launch in Europe.”