The Journal of mHealth Vol 2 Issue 4 (August) | Page 10

INDUSTRY
NEWS
News and Information for
Digital Health Professionals

FDA Approves iOS-based Spinal
Cord Stimulation Trial System
the treatment will work for them
with no invasive surgery.
“By providing a more patientfriendly option, we think we can
shorten the learning curve related
to trial programming devices and
allow patients to better
assess the potential pain
relief they’re receiving from
spinal cord stimulation.”

St. Jude medical has announced that its
new wireless spinal cord stimulation trial
system has been approved by the FDA.
The system, which received a CE Mark
in June 2015, is a fully wireless system
designed to provide patients a more
improved and discreet spinal cord stimulation (SCS) trial experience.

8

The device allows patients to test out
spinal cord stimulation treatment before
having a permanent device implanted in
their back. This helps determine if

August 2015

For many patients, SCS
therapy can be an effective
option for managing
chronic
pain. The therapy
relies on a small
implanted device
and thin wires
(known as leads)
to deliver low levels of electrical
energy to mask
or interrupt pain
signals as they travel along nerve fibres
to the brain, which reduces the sensation
of pain. Prior to receiving a permanently
implanted SCS device, patients undergo a
minimally in vasive “trial” period to evaluate the therapy. Yet for some patients,
complex controllers and bulky programming cables can disrupt the trial experience and act as barrier to SCS therapy.
With the Invisible Trial System, St. Jude
Medical has removed these barriers,
allowing patients to more effectively eval-

uate their SCS therapy. The system relies
on Bluetooth® wireless technology to
provide patients a safe, secure and entirely
wireless SCS trial experience. Rather than
a complex controller, the St. Jude Medical
Invisible Trial System provides patients
with a more intuitive iPod touch digital
device as a controller, while physicians will
utilise an iPad mini digital device to program and evaluate their patient’s therapy.
“Patients undergoing SCS trials consistently tell us about challenges they find
in navigating the SCS trial system, from
programming the device, to discomfort from the programming cables, to
management of both issues. These hindrances may impede the integration of
the technology into their daily activities,
which shifts their focus away from evaluating the effectiveness of SCS therapy,”
said pain specialist Dr. Jason E. Pope,
president of Summit Pain Alliance in
Santa Rosa, Calif. “By providing a discreet trial system, St. Jude Medical will
help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems.”
One of the key system features of the
St. Jude Medical Invisible Trial System is the use of a small external pulse
generator (EPG) as the system’s power
source. Because the EPG uses Bluetooth
wireless technology to communicate
between the patient’s iPod touch controller and the stimulation system, the over-