ABBOTT PARK, Ill., Sept. 26, 2019
/PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S.
Food and Drug Administration (FDA) has approved the company's
Proclaim XR™ recharge-free neurostimulation system for people
living with chronic pain. The Proclaim XR platform offers a low
dose of Abbott's proprietary BurstDR™ stimulation
waveform, which was created based on scientific insights from
doctors and research to mimic natural patterns found in the brain.
It works by using low doses of mild electrical pulses to change
pain signals as they travel from the spinal cord to the brain. The
delivery of lower doses of spinal cord stimulation (SCS) helps
extend the system's battery life, allowing people to experience
pain relief, without the hassle of recharging, for up to 10
years*.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8608451-abbott-proclaim-xr-spinal-cord-stimulation-system/
Abbott's low-energy stimulation is based on finding the lowest
effective dose as determined by the treating clinician for select
patients. It delivers BurstDR stimulation intermittently, at low
energy levels, while allowing people to experience the same level
of superior pain relief. Proclaim XR also uses familiar Apple
mobile digital devices and Bluetooth® wireless
technology to help discreetly manage pain and fit seamlessly into a
patient's lifestyle.
The system was developed based on positive results from Abbott's
BurstDR micrOdosing stimuLation in
De-novo patients (BOLD) study, which showed 100% of
24 enrolled patients on a low-energy BurstDR dosing program
experienced pain relief with less than six hours of battery use per
day, while approximately 50% of those patients achieved pain relief
with the lowest effective dose (less than two hours of battery use
per day). Even at the highest settings, the systems were still in
use only 25% of the time. Data from this trial was presented at
multiple society meetings including the North American
Neuromodulation Society (NANS) and the International
Neuromodulation Society (INS) earlier this year.
"For the 50 million people living with chronic pain in
the United States this is a new
and exciting treatment that is supported with evidence validated by
the BOLD study, an established protocol for titrated intermittent
dosing to give patients individualized pain relief while
using therapy for 6 hours or less per day," said Timothy Deer, M.D., DABPM, president and chief
executive officer of The Spine and Nerve Center of the Virginias in
Charleston, W.Va. "Proclaim XR is
a major advancement in spinal cord stimulation, and is an
evidence-based therapy that is mobile app-based and features
upgradeable software. This means patients won't need surgery to
benefit from future advances in this technology."
Alternative stimulation systems may use higher frequencies or
multiple waveforms that use more energy, requiring them to be
recharged daily – taking time from a person's day. Abbott's
Proclaim XR system allows physicians to identify the lowest
effective dose of BurstDR stimulation customized to each patient,
optimizing system longevity while maintaining effective pain
relief, and eliminating the need for recharging (for up to 10 years
at low-dose settings*). This patient-centric
innovation is possible because of Abbott's proprietary waveform and
advanced battery technology that is integrated into Proclaim
XR.
"Proclaim XR is a new and differentiated advancement in how we
approach chronic pain management, offering a safe and effective
non-opioid technology for up to a decade of pain relief," said
Jacqueline Weisbein, D.O., Napa
Valley Orthopaedic Medical Group in Napa,
Calif. "Having access to reliable pain relief – from a
system that doesn't have the hassle of needing to be recharged –is
a gamechanger in helping people live their best lives, free from
pain."
Living With Chronic Pain On Her Terms
Sara Smith, 33, is a trained medical technician
and loves the outdoors. As a young girl, she was diagnosed
with scoliosis and, in 2006, she had spinal fusion surgery.
Not deterred, she remained active and continued to hike, camp, and
even ran a few marathons. Unfortunately, while riding a dirt
bike in 2012, she had a serious accident that broke one of her
spinal fusion bolts, which was the start of her debilitating
chronic pain. Sara tried physical therapy, injection therapy
and pain medications before being introduced to spinal cord
stimulation therapy. In her clinical trial experience, she
reported a reduction in pain by 75%, and was eager to receive her
permanent implant as one of the first patients receiving Proclaim
XR.
"I didn't realize how much pain I was really in until the
Proclaim XR system trial," Smith said. "I was able to reclaim
my life and can be the involved mom and wife I was before my
accident. My Proclaim XR device's long battery life will
allow me to be an active participant in my own life, without having
to worry about finding someplace where I can charge my
device. While I may never be completely pain free, my pain
level is significantly reduced, allowing me to focus on the things
that matter the most to me and my family."
Similar to Sara, approximately 50 million people in the US are
affected by chronic pain, many of whom could benefit from spinal
cord stimulation.
"Proclaim XR is the latest advancement in patient-centric pain
therapy -- opening the doors for people who don't want to be
burdened with the hassles of recharging. Recharge-free means
patients can live their lives without the constant reminder of
being in treatment," said Keith
Boettiger, vice president of Abbott's neuromodulation
business. "This is a meaningful advancement for the millions of
people who need new options when it comes to managing the effects
of their chronic pain. Abbott is committed to developing
life-changing solutions and putting the patient at the center of
everything we do."
Proclaim XR is currently under review for CE Mark.
Learn more about Proclaim XR and further clinical evidence to
support Abbott's BurstDR stimulation. For important safety
information, visit: abbott.com/isi.
About Abbott's Chronic Pain Portfolio
Chronic pain
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 in the portfolio of devices for the treatment
of chronic pain.
The Proclaim XR system is the latest advancement from Abbott,
featuring upgradeable software and consumer-friendly technology
that is compatible with Apple devices such as the
iPhone® or iPad® or iPod
Touch®.
About Abbott
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
103,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on Facebook
at www.facebook.com/Abbott and
www.facebook.com/AbbottChronicPain on Twitter
@AbbottNews and @AbbottGlobal.
* Up to 10 years of projected battery longevity at the
lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off.
NOTE: In neurostimulation therapy, 'dose' refers to the
delivery of a quantity of energy to tissue. Safety comparisons and
specific dose-response curves for each dosage have not been
clinically established. Refer to the IFU for additional
information. Hassle-free means recharge-free. The BoldXR Dosing
Protocol is only a guide and each patient should be programmed as
needed to ensure the best outcome. It should not replace the IFU or
recommendations and advisement of the treating health care
practitioner.
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SOURCE Abbott