Ellipse Technology receives FDA 510(k) clearance for MAGEC spine system

Ellipse Technologies Inc. recently announced in a press release that it received FDA 510(k) clearance to market its MAGnetic Expansion Control Spinal Bracing and Distraction System.

According to the release, the MAGEC system is now available for use in skeletally immature patients aged less than 10 years who have severe progressive spinal deformities that are associated with or are at risk of thoracic insufficiency syndrome.

“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,” Ed Roschak, President and CEO of Ellipse Technologies, stated in the release.

Traditional growing rods, according to the release, provide a growth-friendly way these spinal deformities can be treated, but require repeated and regular lengthening surgeries throughout the child’s growing years. The MAGEC system provides an alternative to the treatment that is a non-invasive way to perform the needed lengthening, eliminate the repeated surgeries and it may yield significant socioeconomic benefits to patients and their families, company officials noted in the press release.

To date, the MAGEC system has been used by more than 150 surgeons in 24 countries, according to information in the release.