ABBOTT PARK, Ill., Nov. 15, 2018
/PRNewswire/ -- Abbott (NYSE: ABT) today announced the launch
of the new DRG Invisible Trial System, which is approved by the
U.S. Food and Drug Administration (FDA) and received CE Mark in
Europe. People battling complex
chronic pain conditions can now use the DRG Invisible Trial System
to try Abbott's dorsal root ganglion (DRG) stimulation—a clinically
proven, non-opioid treatment option for targeted chronic pain
management. Patients who find adequate pain relief with DRG therapy
can then have Abbott's Proclaim™ DRG system implanted, empowering
them to manage their pain with familiar Apple consumer
technology.
A form of neurostimulation, Abbott's DRG therapy specifically
targets the dorsal root ganglion—a structure adjacent to the spinal
cord densely populated with sensory nerves that transmit chronic
pain to the central nervous system. The therapy helps people living
with neuropathic pain conditions by blocking pain signals with
electrical pulses transmitted over the DRG. Clinical research, such
as the ACCURATE study, has demonstrated that DRG therapy can
provide superior pain relief when compared to traditional spinal
cord stimulation (SCS) therapy for patients with persistent
neuropathic focal pain conditions. Focal chronic pain conditions,
including complex regional pain syndrome (CRPS), are some of the
most prevalent and under-treated forms of chronic pain around the
world.
How Abbott's DRG Invisible Trial Works
Abbott's DRG
Invisible Trial System allows for a minimally invasive evaluation
period. During an outpatient procedure, thin wires are placed in
the spinal column near the DRG and a small, external battery is
hidden discreetly under clothes "invisible" to the public. For
about a week, the patient uses an Apple iPod touch to manage their
pain relief—changing the stimulation settings within prescribed
limits to evaluate how DRG therapy targets their body's chronic
pain symptoms. Earlier generation trial systems involved complex
controllers connected to bulky programming cables, which were known
to disrupt the trial experience and act as a barrier to effective
therapy.
Abbott's new DRG Invisible Trial System follows the company's
Invisible Trial System for BurstDR stimulation, which launched in
2015 to allow a discreet and effective way to evaluate SCS.
"With Abbott's pioneering work to provide new options to treat
different types of chronic pain, the intuitive DRG Invisible Trial
System gives pain sufferers new hope," said Allen Burton, M.D., medical director of
neuromodulation at Abbott. "By enabling a temporary trial, people
can test the treatment before receiving a permanent implant. If
they experience meaningful pain relief, they can choose to move
forward with our DRG therapy and find long-term pain relief—helping
them live a fuller, healthier life again without relying on
opioids."
Abbott is the first and only company in the world with FDA
approval and CE Mark to offer DRG therapy through an evaluation
period and implantable neurostimulation device. Since it's
commercialization, adoption of the therapy has accelerated quickly:
procedures have been performed by hundreds of physicians across
three continents, with new physicians being trained continually on
the procedure.
"Internationally, governments and health agencies are
prioritizing new therapies that can combat chronic pain patients'
exposure to addictive pain medication," Burton said.
A Non-Opioid Treatment for Chronic Pain
An alarming
1.5 billion people around the world are affected by chronic pain.
While opioids are a prescribed therapy, an estimated 15.5 million
people worldwide are considered opioid dependent. Prescription
opioid medication can have an important role in helping patients
manage acute (short-term) or cancer pain; however, these drugs lack
evidence as an effective treatment to treat chronic (long-term)
pain.
Compounding the challenge, neuropathic conditions like CRPS have
been difficult for physicians to treat because the pain stems from
damage to the body resulting in a disruption of how the peripheral
and central nervous systems process or transmit pain signals.
Examples of these conditions may include chronic pain following
hernia repair, total joint replacements or amputation. Worse,
neuropathic pain conditions are often characterized by intense
shooting pain or a burning sensation. In their search for pain
relief, many people try medications including opioids and undergo
surgery without success. DRG stimulation therapy is proven to
provide superior relief for people suffering from CRPS and other
intense, lower-limb pain when compared to SCS.
Highlighting neurostimulation's role in combatting opioid
reliance in chronic pain patients, Timothy
Lubenow, M.D., one of the leading international pain experts
and medical director of The Rush
University Medical Center Pain Clinic in Chicago, said: "Considering the societal costs
and negative long-term impact on people, the full cost of opioid
medication cannot be measured by their price alone. Alternative
interventional therapies that might be more expensive initially can
be exponentially less expensive in the long run."
Combating the Chronic Pain Crisis with Innovation
From circuit board to effective hand-held management of chronic
pain, Abbott's DRG therapy is an innovative technology for pain
management. Learn more about why physicians and patients are using
this non-opioid treatment and watch Abbott's Everyday Innovators
video.
About Abbott's Chronic Pain Portfolio:
Chronic pain affects approximately 1.5 billion people worldwide,
more than heart disease, cancer and diabetes combined. The
condition can negatively impact personal relationships, work
productivity and a person's daily routine. Abbott is a global
leader in the development of chronic pain therapy solutions,
offering radiofrequency therapy and spinal cord stimulation therapy
solutions, including BurstDR™ stimulation, and stimulation of the
dorsal root ganglion for the treatment of chronic pain.
Read U.S. important safety information on DRG therapy. Read
international important safety information on DRG therapy.
Note: Apple and iPod touch are trademarks of Apple, Inc.
Bluetooth is a registered trademark of Bluetooth SIG, Inc.
About Abbott
At Abbott, we're committed to helping
people live their best possible life through the power of health.
For more than 125 years, we've brought new products and
technologies to the world — in nutrition, diagnostics, medical
devices and branded generic pharmaceuticals — that create more
possibilities for more people at all stages of life. Today, 99,000
of us are working to help people live not just longer, but better,
in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook
at www.facebook.com/Abbott and
www.facebook.com/AbbottChronicPain on Twitter @AbbottNews and
@AbbottGlobal.
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