Ellipse Technologies had completed the initial clinical study enrollment for its MAGnetic Expansion Control (MAGEC) Technology in 'At Risk Early Onset Scoliosis Patients.' The company has developed the MAGEC Technology for minimally invasive and non-invasive, orthopedic deformity prevention and management.
MAGEC Technology is a medical device technology capable of non-invasively adjusting (expandable and reversible) implants within the human body from outside the body via remote control. The first application for this technology is for the treatment of spinal scoliosis in children.
The study has enrolled a total of 25 patients in six hospital centers located in three countries. Each of the patients has received either one or two of the MAGEC implants as prescribed by the participating clinical investigator. The majority of patient procedures have been conducted using a minimally invasive surgical procedure.
During the ensuing months following the implant procedure, a series of non-invasive dynamic expansion procedures of the MAGEC distracting rod are completed to lengthen the implant to help straighten the spines of the growing children.
In the patients, dynamic expansion of the implant has been completed with the MAGEC External Remote Controller (ERC) in a totally non-invasive, outpatient procedure. Ellipse will continue to follow the patients in this study as these non-invasive adjustments continue over the next several months and years.
With the MAGEC Technology, a single minimally invasive surgical procedure is completed. Then, during a series of routine outpatient visits, the physician will adjust the MAGEC Technology from outside the body via the MAGEC ERC System, thus eliminating the need for multiple highly invasive surgical procedures.
Michael Henson, chairman of Ellipse, said: “The possibility of having only a single minimally invasive procedure to be followed up by a series of five-minute non-invasive adjustments is quite compelling to both these young patients and their parents.
“The initial procedures to position the MAGEC implants, as well as the non-invasive adjustments, have been completed very smoothly and without complications. We look forward to the formal presentation of the results of this study later this year.”