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Nevro HF10 Therapy: Labeled as Superior to Traditional SCS for Back Pain and Leg Pain

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HF10TM THERAPY: DEVELOPED THROUGH BEST-IN-CLASS CLINICAL EVIDENCE

Neuromodulation has been used for decades to treat chronic pain. Yet despite its widespread adoption, limited published, prospective, long-term evidence about the efficacy of traditional spinal cord stimulation (SCS) existed. Nevro understands the critical importance of clinical evidence in today’s environment and has produced world class evidence to advance SCS therapy. No other company has committed so fully to establishing clinical evidence of the safety and efficacy of SCS treatment and no other SCS technology has the wealth of clinical study data to back its technology.

SENZA-RCT: A first-of-its-kind study

THE FIRST MULTICENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED PIVOTAL STUDY OF AN SCS SYSTEM.

First randomized, pivotal study of an SCS system

  • Largest RCT study for back pain and leg pain: 241 participants enrolled, 198 randomized, 171 implanted

First study to directly compare SCS technologies

  • HF10™ therapy compared to traditional SCS

First RCT study to enroll patients with BOTH back pain and leg pain

  • Inclusion criteria required VAS of ≥5 for BOTH back pain and leg pain

First SCS study to report on 100% of patients to 12 months

  • 171 implanted patients followed to 12 months

HF10TM Therapy: Labeled as Superior to Traditional SCS for Back Pain and Leg Pain

HF10 therapy was labeled superior to traditional SCS due to the rigor and outcomes of the SENZA-RCT. The study demonstrated superiority at all primary and secondary endpoints vs traditional SCS.

MORE PATIENTS

HF10™ therapy delivered superior back pain and leg pain response.

MORE PAIN RELIEF

HF10 therapy delivered superior reduction in both back pain and leg pain at all measured time points.

WITH NO PARESTHESIA

HF10 therapy is the only SCS therapy indicated as paresthesia-free.

  • Eliminates restrictions on driving and sleeping
  • Improves patient satisfaction

The Senza® system: Superior outcomes delivered through best-in-class technology

  • The only IPG indicated to deliver paresthesia-free therapy
  • The only SCS system that is 1.5 and 3 Tesla MRI compatible for head and extremity scans
  • The only IPG with 10-year-plus battery life at 10 kHz
  • The only IPG that can provide HF10 therapy
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