EU approval and first European implant for ANS neurostimulation system
19 May 2006
Plano Texas, USA.
Advanced Neuromodulation Systems (ANS), the neuromodulation business of St.
Jude Medical, Inc. (NYSE:STJ), has received European CE Mark clearance for
its Eon rechargeable neurostimulation system, and announced the first
European patient implant.
Eon Neurostimulation System helps patients manage chronic, intractable pain
of the trunk and limbs, including pain associated with failed back-surgery
syndrome, by using low-intensity electrical impulses to selectively trigger
nerve fibres along the spinal cord. It is though that stimulating these
nerve fibres diminishes or blocks the intensity of the pain message being
transmitted to the brain, replacing feelings of pain with tingling
Neurosurgeon Athanasios Koulousakis, M.D., performed the first
European implant at University Hospital in Cologne, Germany. “The Eon was
easy to implant and the patient has responded well to the targeted pain
relief this neurostimulation therapy offers,” said Dr. Koulousakis. “Eon is
a good option for patients who need high power stimulation settings and want
the convenience of a rechargeable device.”
The Eon implantable pulse
generator (IPG) is designed to last a minimum of seven years at high power
settings. This allows patients to go longer between battery replacement
surgeries. Eon can power up to 16 independent electrodes, which allows
clinicians more programming options to better manage the patient’s pain.
“Physicians throughout the European Union will now have a broader choice
among neurostimulation systems to treat their patients,” said Chris Chavez,
president of ANS. “We believe that patients will appreciate how easy the
system is to use. They simply recharge the device periodically, just as they
would their cell phone.”
Spinal cord stimulators like Eon are implanted devices that are similar
in function and appearance to cardiac pacemakers. To have a spinal cord
stimulator or “pain pacemaker” implanted, a patient must undergo a minor
surgical procedure in which a lead or leads are placed in the epidural space
and connected to a generator, which serves as the power source and
programming “brain.” Once activated, the system’s programs are adjusted and
fine tuned to best control the patient’s pain. Patients use a controller
(similar to a remote control) that allows them to check the system’s
battery, adjust the power level, select from pre-set programs and turn the
system power on and off.
Chronic pain is a largely under treated and misunderstood disease that
affects millions of patients worldwide. It is defined as pain that persists
for more than six months after an injury, reoccurs periodically over six
months, and continues for an indefinite period of time. As many as one in
five people suffers from moderate to severe chronic pain, and one in three
people is unable or less able to maintain an independent lifestyle due to
pain (according to the World Health Organization in conjunction with The
European Federation of the International Association for the Study of Pain).
The Eon System was approved by the U.S. Food and Drug Administration (FDA)
in 2005. More than 25,000 patients in more than 25 countries around the
world use ANS neurostimulation therapies to manage chronic pain.