HF10 THERAPY proven to provide patients superior relief from back pain and leg pain.
The only spinal cord stimulation therapy APPROVED to deliver pain relief without paresthesia.
8 OUT OF 10 people who try HF10 therapy have significant
relief of back pain and leg pain.
   

Clinical Evidence

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. In fact, HF10 therapy is now backed by the two most recent prospective trials to 24 months, SENZA- EU and SENZA-RCT, representing the most robust body of clinical evidence for any one SCS therapy.

COMPARATIVE, FEASIBILITY

  • 5 centers, 24 patients trialed with both traditional SCS and HF10 therapy
  • Demonstrated safety and efficacy in humans (acute follow-up)
  • 88% of patients preferred HF10 therapy
  • Published in Neuromodulation
    (Click for abstract.)

2009

U.S. FEASIBILITY STUDY1

PROSPECTIVE, LONG-TERM

  • 2 centers, 72 patients implanted
  • Demonstrated long-term safety and efficacy for both back pain and leg pain
    (24-month follow-up)
  • Published in Pain Medicine
    (Click for full text.)

2013

EUROPEAN MULTICENTER,
24-MONTH STUDY (SENZA-EU)2

RANDOMIZED, CONTROLLED

  • 10 U.S. centers, 241 enrolled,
    198 randomized, 171 implanted
  • Randomized, controlled trial compared HF10 therapy with traditional SCS
  • Demonstrated superiority at all primary and secondary endpoints vs traditional SCS
  • 12 month data published in Anesthesiology
    (click for full text)
  • 24 month data published in Neurosurgery
    (click for full text)

2015

U.S. PIVOTAL STUDY TO 24-MONTHS (SENZA-RCT)3