- The new indication for Abbott's Proclaim™ XR SCS system
provides a non-medication option for people with painful diabetic
peripheral neuropathy
- Spinal cord stimulation is proven to be more effective than
conventional medical management in the treatment of chronic
pain1,2
ABBOTT
PARK, Ill., Jan. 26,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced
today that the U.S. Food and Drug Administration (FDA) has approved
its Proclaim™ XR spinal cord stimulation (SCS) system to treat
painful diabetic peripheral neuropathy (DPN), a debilitating
complication of diabetes. The Proclaim XR SCS system can provide
relief to DPN patients in need of alternatives to traditional
treatment approaches, such as oral medication. People who
receive therapy from the Proclaim XR SCS system will also be able
to use Abbott's NeuroSphere™ Virtual Clinic, a connected care
app that allows people to communicate with a physician and receive
treatment adjustments remotely.
Roughly 34.2 million Americans, or 10.5% of the U.S. population,
have diabetes.3 Diabetic neuropathy, one of the
complications of diabetes, is a type of damage seen predominately
in nerves running to the feet.4 During their lifetime,
approximately 50% of adults with diabetes will develop peripheral
neuropathy, which may include symptoms such as pain and numbness in
the legs, feet and hands.5
Currently, there are no disease modifying treatments for DPN,
only symptom management and behavioral modifications to mitigate
further nerve damage that can result from high blood sugar
(glucose) levels.6 Spinal cord stimulation is a
non-opioid approach that has been used for more than 50 years to
help manage chronic pain and is proven to be more effective than
conventional medical management in the treatment of this type of
chronic pain.1,2 As a global leader in diabetes care,
Abbott is committed to bringing life-changing solutions, including
diagnostics, nutritionals, medicines and medical devices such as
spinal cord stimulation to help better the lives of people living
with diabetes.
Approved for the treatment of chronic pain in 2019, the Proclaim
XR SCS system now offers DPN patients relief from chronic pain by
delivering low amounts, or doses, of stimulation. Unlike other SCS
systems that require frequent charging sessions to maintain
therapy, the Proclaim XR SCS system provides hassle-free
pain relief with a battery that lasts up to 10 years at low-dose
settings.§ People experiencing DPN can engage with
their healthcare provider to be referred to a pain management
specialist or spine surgeon to discuss the details of this
treatment to determine the best course of care.
"Diabetic peripheral neuropathy has long plagued
people affected by type 1 and type 2
diabetes, often adding another area of disease
management on top of their ongoing monitoring
of their glucose levels to manage this
challenging disease," said Jason E. Pope, MD, DABPM,
FIPP, president of Evolve Restorative Center in Santa Rosa,
Calif. "Abbott's Proclaim XR spinal cord stimulation
system provides patients with painful diabetic
peripheral neuropathy the opportunity to obtain a better
quality of life while more seamlessly fitting into their current
lifestyles."
Following a successful minimally invasive trial and undergoing
an implant with the Proclaim XR SCS device, patients will have the
ability to control their therapy through an
Apple device. The device can also be programmed using the
company's proprietary NeuroSphere Virtual Clinic technology, a
first-of-its-kind remote patient care technology in U.S. that
allows users to communicate with physicians, ensure proper settings
and functionality, and receive new treatment settings/adjustments
remotely, as needed.*
"As a leader in diabetes care, Abbott is intimately familiar
with the challenges people with diabetes encounter daily. This new
indication for Proclaim XR will drive meaningful change in the
treatment of pain associated with diabetic peripheral neuropathy
and will be an important tool for physicians and patients in
managing this debilitating condition," said Pedro Malha, vice
president, neuromodulation, Abbott.
*Anywhere with a cellular or Wi-Fi connection and sufficiently
charged patient controller.
§Up to 10 years of 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.
For U.S. important safety information on the Abbott Proclaim™ XR
SCS system, visit:
https://www.neuromodulation.abbott/us/en/important-safety-info/ht-tab/proclaim™-xr-and-prodigy™-scs-systems.html.
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 115,000
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 Slangen, R., et al. (2014). "Spinal cord
stimulation and pain relief in painful diabetic peripheral
neuropathy: a prospective two-center randomized controlled trial."
Diabetes Care 37(11): 3016-3024.
2 de Vos, C. C., et al. (2014). "Spinal cord stimulation
in patients with painful diabetic neuropathy: a multicentre
randomized clinical trial." Pain 155(11): 2426-2431.
3 Center for Disease Control & Prevention. National
Diabetes Statistics Report 2022 - Estimates of Diabetes and Its
Burden in the United States.
https://diabetesresearch.org/wp-content/uploads/2022/05/national-diabetes-statistics-report-2020.pdf.
Accessed November 9, 2022.
4 Schreiber, A., Nones, C., Reis, R., Chichorro, J.,
& Cunha, J. (2015). Diabetic neuropathic pain: Physiopathology
and treatment. World Journal of Diabetes, 6(3), 432–444.
5 Hicks, C. W., & Selvin, E. (2019). Epidemiology of
Peripheral Neuropathy and Lower Extremity Disease in Diabetes.
Current Diabetes Reports, 19(10), 86.
https://doi.org/10.1007/s11892-019-1212-8.
6 Petersen, E., Stauss, T., Scowcroft, J., Brooks, E.,
White, J., Sills, S., et. al (2022). Durability of High-Frequency
10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic
Neuropathy Refractory to Conventional Treatments: 12-Month Results
From a Randomized Controlled Trial. Diabetes Care, 45 (1):
e3–e6. https://doi.org/10.2337/dc21-1813.
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SOURCE Abbott