FDA Clears Ellipse Technologies’ Spinal Deformity Treatment

Ellipse Technologies, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its MAGEC (MAGnetic Expansion Control) Spinal Bracing and Distraction System.

The MAGEC system now is 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 an alternative to this emotionally and physically painful treatment regimen. Its non-invasive lengthening technology eliminates the need for repeat lengthening surgeries, resulting in significant socio-economic benefits to the patients and their families.

“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,” said
Ed Roschak, President/CEO of Ellipse Technologies.

To date, the MAGEC system has been used by more than 150 surgeons in 24 countries to treat more than 750 children. Ellipse has worked collaboratively with the FDA to make this device available for use in the United States.

“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.” said Behrooz Akbarnia, M.D., past president of the Scoliosis Research Society and a world renowned pioneer in advanced treatments for scoliosis in young children. “Now, we have the opportunity to offer this surgical treatment option to patients and families in the United States.”

Ellipse Technologies Inc. is a privately held othopedic and spinal device developer in Irvine, Calif.In addition to the MAGEC system, Ellipse markets the PRECICE limb lengthening system.

A paper (#161) by Akbarnia et al, “Traditional Growing Rods Versus Magnetically Controlled Growing Rods for the Surgical Treatment of Early Onset Scoliosis: A Case-Matched Two-Year Study,” will be presented on March 12 in Room 265 at the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS). This paper will highlight the following:

• 24 patient retrospective look comparing surgical outcomes of TGR versus MCGR
• No statistical difference comparing the two groups in major curve correction or gain in spinal or thoracic curve height after two year treatment.
• Both groups experienced similar rates of implant related complications.
• MCGR patients were subjected to significantly less open surgical procedures than TGR-16 open surgeries and 137 non-invasive lengthenings versus 12 index procedures and 56 surgical lengthenings, or 73 open surgeries.
• Four of the 12 (33 percent) MCGR patients had at least one complication while 11 of 12 (92 percent) of the TGR patients had at least one complication.