IRVINE, Calif.--(BUSINESS WIRE)--Ellipse Technologies, Inc., a global medical device company, reports that its MAGEC (MAGnetic Expansion Control) system has received strong recommendations from the National Institute for Health and Care Excellence (NICE) and the British National Health Service (NHS). The recommendations were triggered by recently published medical technology guidance from NICE, encouraging the NHS to use the MAGEC system in children aged two years and over who suffer from early onset scoliosis. This was then followed by a published draft policy by NHS with a similar endorsement. Using the MAGEC system means the young early onset scoliosis patient can avoid the alternative - a series of multiple lengthening surgeries and the associated discomfort, effects, and risks that come with them.
NICE, the British independent body responsible for driving improvement and excellence in the health and social care system, provided the following comments in its recommendation: “The case for adopting the MAGEC system for spinal lengthening in children with scoliosis is supported by the evidence. Using the MAGEC system would avoid repeated surgical procedures for growth rod lengthening. This could reduce complications and have other physical and psychological benefits for affected children and their families.”
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said: “We are delighted to publish this guidance, which can help make a real difference to children who need surgery for a curved spine. The NICE guidance advises that the MAGEC system can benefit these children with scoliosis, and save the NHS money. Where standard treatment for scoliosis such as a back brace hasn't worked…the MAGEC system offers a real improvement over the current surgical option involving conventional growth rods.”
News of the NICE and NHS recommendations follows on the heels of MAGEC’s FDA 510(k) clearance and first cases in the United States earlier this year. The MAGEC system was cleared by the FDA 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 distraction procedure eliminates the need for repeated lengthening surgeries resulting in significant health, psychological and socioeconomic benefits for the patients and their families.
To date, the MAGEC system has been used by more than 200 surgeons in 24 countries in the surgical treatment of more than 1,000 children.
Ellipse Technologies is currently displaying its MAGEC system at the Scoliosis Research Society’s IMAST: the 21st International Meeting on Advanced Spine Techniques in Valencia, Spain, July 16th – 19th.
The full NICE medical technologies guidance, “The MAGEC System for Spinal Lengthening in Children with Scoliosis,” is available at http://guidance.nice.org.uk/MTG18.
The NHS’ draft policy regarding MAGEC can be found at: http://www.england.nhs.uk/ourwork/commissioning/spec-services/consultations/.
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.