- The U.S. Food and Drug Administration (FDA) approved Abbott's
Eterna™ spinal cord stimulation (SCS) system for the treatment of
chronic pain
- This neuromodulation device provides an optimized experience
with the ability to wirelessly charge as few as five times per
year, the lowest recharge burden compared to other rechargeable SCS
systems §1,2,3
ABBOTT
PARK, Ill., Dec. 19,
2022 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced the U.S. Food and Drug Administration (FDA) approval of
the company's Eterna™ spinal cord stimulation (SCS) system – the
smallest implantable, rechargeable spinal cord stimulator currently
available on the market for the treatment of chronic
pain.*4 Eterna SCS utilizes Abbott's proprietary
low-dose BurstDR™ stimulation, the only SCS waveform
technology with the highest level of clinical evidence (1A
evidence), proven to reduce pain 23% more than traditional waveform
technology approaches.5
Abbott developed Eterna based on extensive studies with
patients, physicians and caregivers to understand the unmet needs
of people living with chronic pain. The studies found that people
wanted a smaller implant for comfort while reducing the need to
charge the device daily or weekly. With patient needs front of
mind, Abbott created Eterna to be recharged less than five times a
year under normal use, making it the lowest recharge burden
platform on the market.§1,2,3
Key features include:
- Smallest device: Designed with daily comfort in
mind6 the Eterna SCS system is the smallest implantable,
rechargeable spinal cord stimulator*4 on the
market.
- Clinically proven therapy: The Eterna SCS system
features Abbott's proprietary BurstDR stimulation, which mimics
natural firing patterns found in the brain7 to deliver
superior**8 pain relief. BurstDR stimulation is
preferred to traditional "tingling" tonic stimulation by 87% of
patients.9
- Lowest recharging requirements: Paired with Abbott's new
Xtend™ energy technology, Eterna optimizes the patient charging
experience, requiring as few as five recharges per year under
standard use from a wireless
charger.§1,2,3
- MRI capabilities: Eterna uses Abbott's TotalScan™ MRI
technology, which allows for full-body MRI scans – a critical need
of chronic pain patients who require accessibility to improved
diagnostics and healthcare.
- Upgradable platform: As Abbott continues to make
advancements in SCS therapy, the Eterna SCS system can adapt to
future innovations without replacing the implant.
- iPhone integration: Abbott's patient-focused mobile app
supports real-time battery life and charging status updates of the
Eterna SCS system on a personal or Abbott-provided Apple
device.
"Abbott's low-dose BurstDR stimulation is clinically proven to
reduce pain, improve people's ability to perform everyday
activities, and reduce emotional suffering associated with
pain,"^8 said Timothy
Deer, M.D., DABPM, president and chief executive officer of
the Spine and Nerve Centers of the Virginias in Charleston,
W.Va. "Until now, it wasn't available on a rechargeable device that
was this small, and that only needs to be charged a few times a
year. This makes a big difference in comfort for many patients who
now can have access to the best of both worlds – a small,
best-in-class rechargeable device with superior stimulation
therapy."
More than 50 million people in the U.S. suffer from chronic
pain.10 According to the U.S. Pain Foundation, chronic
pain is the leading cause of people going to the doctor and costs
the nation approximately $635 billion
each year in healthcare, disability and lost productivity
costs.11 SCS, also known as neurostimulation, has been
recommended by doctors for more than 50 years to help people manage
chronic pain and improve their quality of life. Devices used for
SCS consist of thin wires placed between the spinal cord and the
vertebrae and a small implant placed under the skin in the lower
back that helps disrupt pain signals before they can reach the
brain.
"At Abbott, we deliver products and solutions with the goal of
simplifying healthcare, improving clinical outcomes and providing
people suffering from chronic pain with the best experience
possible. As we progress on this commitment, Eterna is the next
major leap forward," said Pedro Malha, vice president,
neuromodulation, Abbott. "Eterna is the smallest rechargeable
spinal cord stimulator on the market, provides the longest therapy
between charges and offers an optimized recharging experience – all
key features when selecting the best overall
system."*§3,4
Abbott's portfolio of neuromodulation devices also includes
Proclaim™ XR, the recharge-free SCS system, and Proclaim Plus
featuring FlexBurst360™, the SCS system that offers pain coverage
across up to six areas of the trunk and/or limbs and enables
programming that can be adjusted as a person's therapeutic needs
evolve. All use the clinically proven low-dose BurstDR stimulation
therapy.
* Smallest size determined by volume in cubic
centimeters.
** BurstDR stimulation superiority when compared to traditional
tonic stimulation as studied in SUBNURST.
^ Pain and suffering as measured by visual analog scale.
§ Approximately one hour per month or three hours
five times per year at standard (nominal) settings for BurstDR™
programs: 30/90 dosing when programmed with amplitude of 0.6mA and
all other BurstDR™ settings are left at default compared to
recommended charging frequency and duration of competitors.
Recommended recharge frequency and duration for competitor product
described in their respective IFU.
For U.S. important safety information on the Abbott Eterna
spinal cord stimulation system, visit: https://bit.ly/3Wgpude.
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 113,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
1 Abbott. Eterna IPG Battery Recharge
Characterization Report (90903492); 2022.
2 Abbott. Eterna IPG Elect Design Verification Report:
Current Draw (90860050). 2022
3 Abbott. Eterna Lowest Recharge Burden Comparison Memo
(MAT-2210739); 2022.
4 Abbott. Eterna SCS IPG Size Comparison Memo
(MAT-2210151); 2022.
5 Karri J, Orhurhu V, Wahezi S, Tang
T, Deer T, Abd-Elsayed A. Comparison of Spinal Cord
Stimulation Waveforms for Treating Chronic Low Back Pain:
Systematic Review and Meta-Analysis. Pain Physician. 2020
Sep;23(5):451-460. PMID: 32967388.
6 Baranidharan G, Bretherton B, Richert G, et al. Pocket
pain, does location matter: a single-centre retrospective study of
patients implanted with a spinal cord stimulator. Reg Anesth Pain
Med. 2020.; 0:1-7. doi:10.1136/rapm-2020-101752
7 De Ridder D., Vanneste, S., Plazier, M., &
Vancamp, T., (2015). Mimicking the Brain: Evaluation of St. Jude
Medical's Prodigy Chronic Pain System with Burst Technology. Expert
Review of Medical Devices, 12(2), 143-150.
8 Deer T, Slavin KV, Amirdelfan K, et al. Success Using
Neuromodulation With BURST (SUNBURST) Study: Results From a
Prospective, Randomized Controlled Trial Using a Novel Burst
Waveform. Neuromodulation. 2017;20(6):543-552.
9 Deer, T. Randomized, Controlled Trial Assessing Burst
Stimulation for Chronic Pain: 2-Year Outcomes from the SUNBURST
Study. Presented at NANS 2018.
10 Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of
chronic pain among adults in the United
States. Pain. 2022 Feb
1;163(2):e328-e332.
11 U.S. Pain Foundation. Chronic Pain Facts.
https://uspainfoundation.org/pain/. Accessed June 27, 2022.
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SOURCE Abbott