Analysis Marks the First Study of Spinal Cord
Stimulation to Demonstrate Long-term, Significant, and
Clinically Meaningful Reductions in HbA1c and Weight in Study
Participants with Painful Diabetic Neuropathy and Type 2
Diabetes
REDWOOD
CITY, Calif., Oct. 29,
2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a
global medical device company that is delivering comprehensive,
life-changing solutions for the treatment of chronic pain, today
announced the publication of new data in the Journal of Pain
Research demonstrating significant, durable pain relief
and long-term and clinically meaningful reductions in hemoglobin
A1c (HbA1c) and weight in study participants with painful diabetic
neuropathy (PDN) and Type 2 diabetes who received 10 kHz
high-frequency spinal cord stimulation (SCS)
therapy.1
Globally, the number of people with diabetes has quadrupled in
the last two decades2, and PDN impacts up to 25% of all
people with diabetes.3 PDN can have significant impacts
on the quality of life for people living with this condition, with
symptoms like numbness, tingling/paresthesia, loss of protective
sensation, impaired balance, and reduced response to sensory
stimuli.4 Patients typically manage PDN with oral pain
medications, but the efficacy of these medications is relatively
low and can result in intolerable side effects.5 As a
result, people with PDN suffer from significantly reduced
health-related quality of life (HRQoL), impaired functionality and
other comorbidities like sleep disorders, depression, and
anxiety.6
The analysis evaluated 144 patients with Type 2 diabetes and
refractory PDN who received 10 kHz SCS therapy during the SENZA-PDN
randomized controlled trial (RCT), the largest RCT to evaluate SCS
to treat PDN. Changes in pain intensity, HbA1c, weight, and sleep
were evaluated over 24 months, with participants stratified
according to preimplantation HbA1c.
At 24 months, the following benefits were noted1:
- Significant, durable pain relief: Study participants had
a mean pain reduction of 79.8% and the mean visual analog scale
(VAS) score for lower limb pain decreased from 7.5 ± 0.1 cm at
preimplantation to 1.5 ± 0.2 cm (p < 0.001).
- Clinically meaningful, statistically significant mean
reductions in HbA1c: Participants with preimplantation HbA1c
>7% and >8% achieved mean reductions of 0.5% (p = 0.031) and
1.1% (p = 0.004), respectively.
- Significant mean weight loss: Across all study
participants, patients achieved a significant mean weight loss of
3.1 kg (p = 0.003). In participant subgroups with body mass indices
(BMI) of ≥ 30 and ≥ 35 kg/m2, mean weight reductions were 4.1 kg (p
= 0.001) and 5.4 kg (p = 0.005), respectively.
- Significant, durable reductions in pain interference with
sleep: Study participants experienced a highly significant
improvement in sleep quality, with pain and sleep questionnaire
three-item (PSQ-3) scores decreasing by a mean of 65.2%,
corresponding to a mean value of 1.9 ± 0.2 cm (p < 0.001).
"People with PDN know that this condition can extend well
beyond pain – impacting sleep, sensory functions, and overall
quality of life," said Dr. David
Klonoff, Medical Director, Diabetes Research Institute at
Mills-Peninsula Medical Center. "This is the first study of SCS to
demonstrate long-term, significant and clinically meaningful
reductions in HbA1c and weight in people with PDN and Type 2
diabetes – suggesting possible metabolic benefits with 10 kHz SCS
for these patients."
"The SENZA-PDN RCT has already demonstrated the significant pain
relief benefit when using Nevro's HFX device for the millions of
people suffering from PDN around the world," said Dr. David Caraway, Nevro's Chief Medical Officer.
"Now, for the first time, we've observed secondary benefits like
improved HbA1c and weight loss, which exhibit potentially
disease-modifying effects for people with Type 2 diabetes. I'm
grateful for the dedication of the clinical investigators who
supported this latest analysis and the broader SENZA-PDN RCT as we
continue gathering data to support market access for more
patients."
The 24-month data from the SENZA-PDN RCT were originally
published in Diabetes Research and Clinical Practice in
2023. These data showed that patients who received a high-frequency
10 kHz SCS implant and conventional medical management (CMM),
compared to CMM alone, experienced durable pain relief and
improvements in HRQoL, neurological function, and sleep at 24
months post-implantation.
To learn more about Nevro's 10 kHz Therapy™ for PDN, visit
www.nevro.com.
References
- Nevro's high-frequency, 10 kHz spinal cord stimulation (SCS)
device has not been approved or evaluated by the U.S. Food and Drug
Administration (FDA) for the treatment of HbA1c and/or weight
loss.
- World Health Organization. (2016). Global report on diabetes.
World Health
Organization. https://apps.who.int/iris/handle/10665/204871
- Shillo P, et al. Painful and Painless Diabetic Neuropathies:
What Is the Difference? Curr Diab Rep. 2019 May 7;19(6):32. doi: 10.1007/s11892-019-1150-5.
PMID: 31065863; PMCID: PMC6505492.
- Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL,
Mizokami-Stout K, et al. Diagnosis and Treatment of Painful
Diabetic Peripheral Neuropathy. Arlington (VA): American Diabetes Association;
2022.
- Yang, M., Qian, C., & Liu, Y. (2015). Suboptimal
Treatment of Diabetic Peripheral Neuropathic Pain in the United States. Pain medicine (Malden, Mass.), 16(11), 2075–2083.
- Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C.,
Stoker, M., Long, S., & van Nooten, F. E. (2015). Humanistic
and economic burden of painful diabetic peripheral neuropathy in
Europe: A review of the
literature. Diabetes research and clinical practice, 109(2),
215–225.
Internet Posting of Information
Nevro routinely posts
information that may be important to investors in the "Investors"
section of its website at www.nevro.com. The company encourages
investors and potential investors to consult the Nevro website
regularly for important information about Nevro.
About Nevro
Headquartered in Redwood City, California, Nevro is a global
medical device company focused on delivering comprehensive,
life-changing solutions that continue to set the standard for
enduring patient outcomes in chronic pain treatment. The company
started with a simple mission to help more patients suffering from
debilitating pain and developed its proprietary 10 kHz Therapy™, an
evidence-based, non-pharmacologic innovation that has impacted the
lives of more than 115,000 patients globally. Nevro's comprehensive
HFX™ spinal cord stimulation (SCS) platform includes the
Senza® SCS system and support services for the treatment
of chronic pain of the trunk and limb and painful diabetic
neuropathy.
Nevro recently added a minimally invasive treatment option for
patients suffering from chronic sacroiliac joint ("SI joint") pain
and now provides the most comprehensive portfolio of products in
the SI joint fusion space, designed to meet the preferences of
physicians and varying patient needs in order to improve outcomes
and quality of life for patients.
Senza®, Senza II®, Senza Omnia™, and HFX iQ are the
only SCS systems that deliver Nevro's proprietary 10 kHz Therapy.
Nevro's unique support services provide every patient with an HFX
Coach™ throughout their pain relief journey and every physician
with Nevrocloud™ insights for enhanced patient and practice
management.
SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz
Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm,
HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo,
HFX COACH, the HFX Coach logo, Nevrocloud, RELIEF MULTIPLIED, HFX
AdaptivAI, the X logo, NEVRO, and the NEVRO logo are trademarks or
registered trademarks of Nevro Corp. Patents covering Senza HFX iQ
and other Nevro products are listed at Nevro.com/patents.
Bluetooth® and the Bluetooth symbol are registered
trademarks of their respective owners.
To learn more about Nevro, connect with us on LinkedIn, X,
Facebook, and Instagram.
Investors and Media:
Angie
McCabe
Vice President, Investor Relations & Corporate
Communications
angeline.mccabe@nevro.com
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SOURCE Nevro Corp.