According to the National Institute of Health (NIH), of every 1,000 children, three to five develop spinal
curves that need treatment. Adolescent idiopathic scoliosis, the most common
type of scoliosis among children, generally occurs after the age of 10 years.
According to the NIH, doctors advise patients to undergo surgery in order to
correct or stop scoliosis that is more than 45º and is showing no signs of
improvement.
Ellipse Technologies Inc. recently developed Magnetic Expansion Control
(MAGEC) technology for improved deformity prevention and management in children
with early onset scoliosis. According to Ed Roschak, chief executive officer,
Ellipse Technologies Inc., the MAGEC technology is capable of adjusting
implants within the human body from outside the body from an external remote
control.
The patient would undergo a surgical procedure in which the surgeon
places the adjustment implant at the appropriate location. The implant has an
internal magnet and a gearing mechanism that allows the surgeon to use an
external remote control. The remote control is a computer controlled motor that
communicates with the implant. The surgeon will adjust the MAGEC technology
during a series of outpatient visits. The adjustment procedure lasts
approximately 5 minutes.
“There is no anesthesia,” Roschak told O&P Business
News. “The patient lies on a normal doctor’s table and the
device is actuated. The surgeon identifies the location of the magnet, which is
similar to a dual-rod construct. The doctor would then identify the location of
the external magnets that are placed in a plastic cover. The doctor would then
feel the magnet within the implant and mark the locations. He or she would then
place our external remote control over that location and adjust the
device.”
The patient can undergo an adjustment and go back to school that same
day.
“We are able to adjust the length, width or angular rotation of the
implant based on communication between the external and internal magnets,”
Roschak said. “We have created an implant that is much like a traditional
growing rod for early onset scoliosis patients. The traditional approach
requires surgery every 6 months to adjust the length of these growing rods as
the child grows.”
The MAGEC device allows the physician to adjust the device without
surgery. The device can be lengthened or shortened in either direction as the
child grows.
“Beyond just replacing multiple surgical procedures; we are able to
do this procedure more frequently,” he said. “Typically, the surgical
adjustments are every 6 months because that is just about as much as the
patient could tolerate in terms of invasive procedures. We have had our
physicians lengthen as much as once a month with a 5 minute office visit. It is
much better way to replicate the true growth experience of the child.”
In terms of working the device, there is a forward and back button that
rotates the magnets to either lengthen or shorten the rod. Physicians would
determine the target length based on the more traditional surgical approach and
depending on the frequency in which the child will visit the physician. The
surgeon dials in the length using the computer software and the machine will do
what the physician asks of it.
“Early onset scoliosis is debilitating and life limiting if not
corrected,” he said. “The patient will need some intervention. But
the intervention may be as bad or worse as the disease. Every 6 months the
patient has surgery which then requires two months of recovery time and just a
few months in between.”
Ellipse is confident their technology can help early onset scoliosis
patients as well as other spinal concerns. The company will address that group
first, and then move beyond early onset scoliosis, focusing on other spine
applications. They are currently working with the Food and Drug Administration
to gain approval for distribution in the United States.
“We have what we consider to be a game-changing platform technology
focusing on spinal applications,” Roschak said. “We see ourselves
going beyond spinal applications to any situation where adjusting an implant
after a surgery provides a benefit to the patient.” — by Anthony
Calabro
Disclosure:Roschak is the chief
executive officer of Ellipse Technologies.