REDWOOD
CITY, Calif., Aug. 10,
2023 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO) has
announced today the launch of HFX Connect in Europe and CE marking of expanded labelling
(Painful Diabetic Neuropathy, PDN and Non-Surgical Back Pain, NSBP)
for the HFX SCS system. The latest development from the global
medical device company delivering comprehensive, life-changing
solutions for the treatment of chronic pain, enables increased
healthcare system efficiencies, patient access to remote
optimisation, and unique labelling for outcomes beyond pain
relief.
"This development marks a significant milestone for Nevro's
commitment to improving patients' access to HFX Therapy and
delivers on the promise of upgradability we made when we launched
the Omnia platform" said Dr. Caraway, CMO of Nevro. "For over a
decade, Nevro has collected unparalleled outcomes data from over
100,000 implanted patients in the HFX Cloud™ and analysed how
multiple programmes improve patient outcomes in different chronic
pain types. All of this has been in preparation for the development
of our data-driven HFX Algorithm™ and our
innovative product pipeline, from which HFX Connect is a great
example."
HFX Connect will be available to both new
Omnia™ patients and those already
implanted, allowing healthcare teams to remotely optimize patients
with 35 pre-programmed customisable treatment plans, and seven
times the amount originally available.
Dr. Ganesan Baranidharan, pain specialist at Leeds University
Hospital said, "HFX Connect will not only deliver the most
versatile SCS therapy for my patients, but its enhanced remote
optimisation capabilities have the potential to optimize healthcare
resources through a reduction of programming time and unnecessary
hospital visits, translating into time and money saving
efficiencies for strained healthcare systems."
In addition, the latest regulatory approval includes expanded
labelling for HFX. HFX is now the world's first and only SCS
therapy with approved CE mark for pain relief and sensory
improvement in PDN patients. The latest specific labelling is for
all major SCS indications, including Back &Leg pain,
Non-Surgical Back Pain, Painful Diabetic Neuropathy and Upper
Limb and Neck pain*.
Furthermore, the labelling now includes expected clinical
benefits beyond pain relief.
Dr. Baranidharan continues, "Outcomes beyond pain relief play
a significant role in judging the success of the therapy for
patients. That's why Nevro has invested heavily over the past ten
years in gathering level 1 and real-world evidence across multiple
patient populations. It's great to see that the
expanded labelling for HFX now also highlights expected
clinical benefits such as profound improvements in function,
quality of life, awareness of positive change as well as a
reduction in opioid use."
The market release of HFX Connect in Europe follows
commercial launch in the USA and
Australia.
*For a complete set of indications refer to EU Manuals.
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content:https://www.prnewswire.co.uk/news-releases/nevro-announces-launch-of-hfx-connect-in-europe-and-ce-marking-of-expanded-labelling-for-the-hfx-scs-system-301897735.html