HFX iQ is the first and only spinal cord
stimulation (SCS) system integrating high-frequency SCS
landmark evidence with cloud data insights, leading the way
for personalized, data-driven patient care*
REDWOOD
CITY, Calif., Nov. 12,
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 that it has received CE Mark Certification in
Europe for its HFX iQ™ spinal cord
stimulation (SCS) system. The CE marking allows Nevro to market HFX
iQ in all countries that recognize this certification.
HFX iQ is the first and only SCS system with artificial
intelligence (AI) technology that combines high-frequency (10 kHz)
therapy built on landmark evidence that uses ongoing cloud data
insights to deliver personalized pain relief.*
"We are thrilled to receive the CE Mark Certification for HFX iQ
as it marks an important milestone in our strategic path to drive
market penetration through our data-backed, AI-powered SCS
therapy," said Kevin Thornal,
Nevro's CEO and president. "Patients in Europe suffering from chronic pain will now
have access to personalized pain relief – and will be able to
maintain that pain relief over time."
"HFX iQ represents a transformative advancement in how we
approach chronic pain management," said Dr. Ganesan Baranidharan,
anesthesia and pain management consultant at Leeds Teaching
Hospital NHS Trust. "By leveraging AI technology and data-driven
programming – developed using over 10 years of outcomes and
real-world patient data – HFX iQ has the potential to not only help
optimize healthcare resources through reduced in-person programming
and unnecessary hospital visits, but it also sets new
standards for earlier and effective pain management along with
patient engagement in spinal cord stimulation."
HFX iQ is digitally enabled and designed to optimize care by
collecting patient data and guiding the patient through a
personalized treatment pathway. It provides several key advantages
over other SCS systems, including:
- Indication-specific HFX Algorithms™ for back and leg pain,
non-surgical refractory back pain, painful diabetic neuropathy,
chronic upper limb and neck pain.
- Customized therapy adjustment recommendations informed by
patient inputs on the HFX App.
- The only 10 kHz Therapy™ that has CE-marked labeling for all
major SCS indications and outcomes beyond pain relief.
"With HFX iQ, we are entering a new era of patient-centered pain
management," said Prof. Faycal El
Majdoub, head of Stereotaxy and Functional Neurosurgery at
Cologne-Merheim Medical Center. "The technology's responsiveness to
individual pain levels and real-time adaptation to patient needs
means empowering patients in their pain relief journey. Patients
experience an enhanced quality of life with few interruptions,
allowing them to reclaim their lives with confidence and with less
dependence on clinical interventions. HFX iQ is truly redefining
what is possible for long-term pain relief."
HFX iQ starts patients on the program most likely to provide
pain relief, based on the HFX Algorithm™, which was built from more
than 20 million data points and 80,000 implanted
patients.1 HFX iQ combines clinical inputs, such as pain
relief and pain score, along with Quality of Life (QoL) inputs,
such as pain medication and activity level changes, to provide an
individualized program setting for each patient.2 HFX iQ
has the ability to program both low frequency and Nevro's
proprietary 10 kHz Therapy, which represents the widest range of
frequencies of any SCS system on the market.
The Senza HFX iQ system is comprised of the HFX iQ Implantable
Pulse Generator (IPG), HFX Trial Stimulator and HFX App. With a new
Bluetooth®-enabled IPG that is upgradeable and connects directly to
the HFX App, each patient can input assessments into their
smartphone and then receive programming adjustments in
real-time.
In addition to receiving CE marking, HFX iQ received U.S. Food
and Drug Administration (FDA) approval in 2022.
Nevro will offer the HFX iQ system in select European countries
starting in the first quarter of 2025.
To learn more about HFX iQ in the U.K., visit
http://nevro.com/English/en/providers/Product-HFX-iQ.
References
* The HFX iQ algorithm is an expert programming system designed
to provide therapy recommendations with the intention to complement
the role of a physician.
- Patients used a Senza, Senza II, or Omnia device offering
10 kHz Therapy.
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 in the U.S. 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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