Nevro has announced 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.
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The latest development from the enables increased healthcare system efficiencies, patient access to remote optimisation, and unique labelling for outcomes beyond pain relief.
Dr. Caraway, CMO of Nevro, said: "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. 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 optimise 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 optimise healthcare resources through a reduction of programming time and unnecessary hospital visits, translating into time and money saving efficiencies for strained healthcare systems."
The latest regulatory approval includes expanded labelling for HFX 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.
The labelling now includes expected clinical benefits beyond pain relief.
Dr. Baranidharan added: "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.
