Data Published in Journal of Neurosurgery:
Spine Highlight Lasting Pain Relief, Enhanced Function, Quality of
Life, and Reduced Opioid Dependency with High-Frequency SCS
Therapy
REDWOOD
CITY, Calif., Nov. 20,
2023 /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 24-month data from the SENZA
Nonsurgical Refractory Back Pain (NSRBP) multicenter randomized
controlled trial (RCT) in the Journal of Neurosurgery:
Spine.
Acute back pain causes more disability around the world than any
other condition1 and a quarter of adults in
the U.S. report they have experienced back pain within the past
three months2 More than 500,000
Americans3 are living with back pain and
either aren't good candidates for it or don't want to have spine
surgery4 to treat it, leaving them with
few treatment options.
The published 24-month data evaluated outcomes for NSRBP
patients treated with Nevro's high-frequency (10 kHz) spinal cord
stimulation (SCS) system plus conventional medical management (CMM)
versus CMM alone. The data show that patients in the high-frequency
SCS arm experienced profound improvements in pain, function, and
quality of life, plus reduced opioid use compared to the CMM arm at
24 months. The long-term data provides further evidence of the
benefits of high-frequency SCS in managing patients with NSRBP.
"People with NSRBP live with pain that can be both physically
and emotionally debilitating, affecting their ability to manage
their everyday lives," said principal investigator Dr. Leonardo
Kapural, physician and researcher at the Carolinas Pain Institute
and Center for Clinical Research. "Patients often turn to unproven
treatments – some with potentially significant harms, like
opioids – when they feel they've run out of options to reduce
their pain. We can see through these data that high-frequency SCS
is capable of giving patients the relief, function, and quality of
life improvements that many are desperate to find."
The 24-month data demonstrated the following benefits for the
125 patients who received 10 kHz Therapy™ within the RCT:
Pain Relief
- 81.6% of all patients who received a permanent implant were
classified as pain responders (achieved ≥50% pain relief) at 24
months, with 58.4% of patients classified as profound responders
who achieved ≥80% pain relief.
- The mean back pain (as measured by the visual analog scale VAS)
significantly decreased from 7.4 at baseline to 1.9, representing a
5.5-point (74%) decrease from baseline.
Function
- Patients reporting a severe level of disability (based on the
Oswestry Disability Index, ODI) decreased from 73% at baseline to
26% of patients at 24 months.
- 75.2% of patients were classified as ODI responders, achieving
a ≥10-point improvement in ODI score. This signals improvements in
the ability to perform daily living activities.
Quality of Life
- Mean EuroQoL-5 Dimension-5 Level (EQ-5D-5L) instrument index
score was significantly increased from 0.570 at baseline to 0.766
at three months after implantation. This 0.19-point improvement was
maintained at 6, 12, 18, and 24 months after implantation. This
score represents ≥2.5 times the minimal clinically important
improvement.
- High levels of patient satisfaction were recorded at 24 months,
with 76% of patients reporting their condition was "better" or "a
great deal better" on Patient-Reported Global Impression of Change
(PGIC).
- Opioid usage was decreased or stopped in 62% percent of
patients who were using opioids at baseline, with the mean dose
decreasing from 35±39 morphine milligram equivalent (MME) at
baseline to 15±35 MME at 24 months.
Safety
- No new safety signals were identified during the 24-month
follow-up, with most study-related adverse events occurring in the
first six months after permanent implantation and no additional
serious adverse events beyond the six reported at 12
months.5,6
- The observed safety profile is consistent with types and rates
of real-world adverse events reported for high-frequency SCS, as
well as safety outcomes generally associated with
SCS.7
"When patients with chronic low back pain don't improve with
conventional therapies and aren't good candidates for spine
surgery, it can leave both the patient and their care team feeling
frustrated by the lack of options," said study investigator Dr.
Naresh P. Patel, associate professor
of Neurosurgery and vice chair of the Department of Neurological
Surgery at Mayo Clinic in Arizona.
"This research demonstrates that high-frequency SCS can address an
unmet need to treat the challenging NSRBP patient population, and
to see results sustained at 24 months is very encouraging."
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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 100,000 patients globally. Nevro's comprehensive
HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS
system and support services for the treatment of chronic pain of
the trunk and limb and painful diabetic neuropathy.
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 HFX
Cloud™ 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, HFX CLOUD, the HFX Cloud logo,
RELIEF MULTIPLIED, 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.
To learn more about Nevro, connect with us
on LinkedIn, Twitter, Facebook and Instagram.
*Senza HFX iQ™ uses a fixed set of instructions to provide
optimized treatment recommendations that utilize direct patient
input from assessments on pain and quality of life measures.
Investors and Media:
Nevro Corp.
ir@nevro.com
1 Hoy D, March L, Brooks P et al. The
Global Burden of Low Back Pain: Estimates from the Global Burden of
Disease 2010 Study. Ann Rheum Dis. 2014; 73(6): 968–74.
2 Deyo R A, Mirza S K, Martin B I. Back
Pain Prevalence and Visit Rates: Estimates from U.S. National
Surveys, 2002. Spine (Phila Pa
1976). 2006; 31(23): 2724–7.
3 Sources: US Census Bureau; CLBP Market
Research; CMS OP Hospital SAF Data 2012–2018.
www.neuromodulation.com/failed-back-surgery-syndrome-definition.
4 Chronic back pain patients who are
refractory to conventional medical management, have no history of
and are not candidates for surgery based on individual preference
or surgeon consult
5 Kapural L, Jameson J, Johnson C, et
al. Treatment of nonsurgical refractory back pain with
high-frequency spinal cord stimulation at 10 kHz: 12-month results
of a pragmatic, multicenter, randomized controlled trial. J
Neurosurg Spine. Feb 11 2022:1-12.
doi:10.3171/2021.12.SPINE211301
6 Eldabe S, Buchser E, Duarte RV.
Complications of Spinal Cord Stimulation and Peripheral Nerve
Stimulation Techniques: A Review of the Literature. Pain Med.
Feb 2016;17(2):325-36.
doi:10.1093/pm/pnv025
7 D'Souza RS, Olatoye OO, Butler CS,
Barman RA, Ashmore ZM, Hagedorn JM. Adverse Events Associated With
10-kHz Dorsal Column Spinal Cord Stimulation: A 5-Year Analysis
of the Manufacturer and User Facility Device Experience
(MAUDE) Database. Clin J Pain. Feb 8
2022;38(5):320-327. doi:10.1097/AJP.0000000000001026
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SOURCE Nevro Corp.