Furthering Nevro's body of evidence as an
innovation leader in pain management, data highlights
the company's posterior integrated transfixation cage
system
REDWOOD
CITY, Calif., Nov. 18,
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 Medical Devices:
Evidence and Research, which demonstrate the superiority of the
Nevro1™ SI Joint Fusion System ("Nevro1"), a posterior integrated
transfixation cage system offering enhanced stability, minimized
bone removal and increased fusion potential compared to a
posterolateral cylindrical threaded single-implant system. Nevro1's
performance also showed that it is equivalent in osteopenic bone
when compared to a lateral triangular rod system in healthy
bone.
The sacroiliac (SI) joints constitute two out of five joints
within the spine-pelvic-hip complex and are responsible for
facilitating load transfer to the torso and lower
extremities.1-3 Joint dysfunction can arise from
conditions such as degeneration, instability, infection or adjacent
segment disease, causing significant pain and impacting daily
activities like walking, sitting and lifting.4-6 Women,
in particular, may experience pronounced discomfort and reduced
quality of life due to SI joint pain.7-8
The study concurrently assessed and compared the fixation
efficacy, invasiveness and fusion potential of a posterior
integrated transfixation cage system (Nevro1) to the posterolateral
threaded implant and lateral triangular rod systems.
Results concluded:
- Nevro1 and the lateral triangular rods produced equivalent
motion reduction in all motion planes.
- Posterolateral cylindrical threaded implant produced less
motion reduction than Nevro1 and lateral implants in
flexion-extension.
- Using Nevro1 for the treatment of SI joint-related pain allows
for the most surface area for fusion, which provides a
significantly better opportunity for robust SI joint
arthrodesis.
"The SI joint is a recognized contributor to low back pain,
significantly affecting daily life for those impacted," said
Douglas Beall, MD, FIPP, FSIR, Chief
of Services, Comprehensive Specialty Care, Clinical Radiology of
Oklahoma. "This study demonstrates
the advantages of the posterior integrated cage system that spans
the SI joint to stabilize it and to address pain associated with SI
joint dysfunction. The Nevro1 device represents a significant
advancement in SI joint fusion, offering greater fixation with
increased fusion potential, and minimal bone removal compared to
other options I have for my patients."
"These findings illustrate the potential benefits of the Nevro1
sacroiliac joint transfixing device, especially in terms of the
post-surgical experience for the patient and opportunity for
long-term fusion and improved patient outcomes," said David Caraway MD, PhD, Nevro's chief medical
officer. "This latest study further establishes this technology as
a promising treatment for patients suffering from SI joint
pain."
About the Nevro1™ SI Joint Fusion System
The Nevro1 System is an FDA 510k-cleared device intended to transfix the SI
joint for immediate stability and long-term fusion. The mechanism
of stabilization consists of integrated transfixing titanium
anchors, which are deployed bilaterally and pierce through the
cortices of the ilium and sacrum to provide immediate axial and
rotational stability of the joint. This device has been proven to
substantially reduce SI joint motion through comprehensive
biomechanics testing performed in collaboration with the FDA. The
proprietary implant design allows for a reduction in motion and
abnormal stress on the SI joint without open surgery. Through a
minimally invasive approach, the implant can be securely placed and
may relieve pain and restore functionality to individuals suffering
from chronic SI joint pain.
To learn more about Nevro's Nevro1 Sacroiliac Transfixing and
Fusion System, visit
https://nevro.com/English/us/safety/sij/default.aspx.
References
- Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK.
Biomechanics of the sacroiliac joint: anatomy, function,
biomechanics, sexual dimorphism, and causes of pain. Int J Spine
Surg. 2020;14(Suppl 1):S3–S13. doi:10.14444/6077
- Newman DP, Soto AT. Sacroiliac joint dysfunction: diagnosis and
treatment. AFP. 2022;105(3):239–245.
- Vleeming A, Schuenke MD, Masi AT, Carreiro JE, Danneels L,
Willard FH. The sacroiliac joint: an overview of its anatomy,
function and potential clinical implications. J Anat.
2012;221(6):537–567. doi:10.1111/j.1469-7580.2012.01564.x
- Lindsey DP, Parrish R, Gundanna M, Leasure J, Yerby SA,
Kondrashov D. Biomechanics of unilateral and bilateral sacroiliac
joint stabilization: laboratory investigation. J Neurosurg Spine.
2018;28(3):326–332. doi:10.3171/2017.7.SPINE17499
- Buchanan P, Vodapally S, Lee DW, et al. Successful diagnosis of
sacroiliac joint dysfunction. J Pain Res. 2021;14:3135–3143.
doi:10.2147/JPR. S327351
- Ha KY, Lee JS, Kim KW. Degeneration of sacroiliac joint after
instrumented lumbar or lumbosacral fusion: a prospective cohort
study over five-year follow-up. Spine. 2008;33(11):1192–1198.
doi:10.1097/BRS.0b013e318170fd35
- Zusman N, Woelber E, McKibben N, et al. Acetabular fracture
pattern is altered by pre-injury sacroiliac joint autofusion. Eurn
J of Orthop Surg and Traumatol. 2023:1–8.
doi:10.1007/s00590-023-03588-w.
- Fassihi SC, Lee D, Tran AA, et al. Total Hip arthroplasty in an
adult patient with pelvic dysmorphism, unilateral sacroiliac joint
autofusion, and developmental hip dysplasia. Arthroplasty Today.
2020;6(1):41–47. doi:10.1016/j.artd.2019.10.006.
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.