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.
   

SENZA-RCT: A first-of-its-kind study1

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

The most rigorous study in SCS history1,2

Rigorous design

  • Designed in consultation with and monitored by the FDA
  • Study design provided an independent control (traditional SCS)
  • Pain relief, responder rates, and functional outcomes tracked and reported at 3, 6, 12, 18 and 24 months.

Rigorous execution

  • Each company had full access to patients and supported programming of their respective SCS system
  • 100% of subjects accounted for through 12 months

SENZA-RCT study design2

Key patient eligibility criteria1

Key inclusion criteria Key exclusion criteria
Chronic, intractable pain of the trunk and/or limbs, refractory to conservative therapy for >3 months Active disruptive psychological or psychiatric disorder
Average back pain intensity ≥5 out of 10 cm on the VAS Mechanical spine instability
Average leg pain intensity ≥5 out of 10 cm on the VAS Prior experience with SCS
Severely disabled or crippled as described by an Oswestry Disability Index score of 41-80 out of 100 Involvement in an injury claim
Appropriate candidate for the required surgical procedures Medical condition or pain that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints
Key exclusion criteria
Active disruptive psychological or psychiatric disorder
Mechanical spine instability
Prior experience with SCS
Involvement in an injury claim
Medical condition or pain that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints

Demographics and characteristics1

BOTH CONTROL AND TEST GROUPS ARE WELL MATCHED DUE TO RANDOMIZATION

Characteristics
Gender - n (%)
Female
Male
Age (years) at enrollment
Mean ± SD
Range
Year Since Diagnosis
Mean ± SD
Range
Previous Back Surgery - n (%)
Baseline of Opioids - n (%)
HF10 THERAPY TRADITIONAL SCS


57 (62.0%) 51 (58.6%)
35 (38.0%) 36 (41.4%)


54.6 ± 12.4 55.2 ± 13.4
32.8 to 82.2 19.2 to 82.3


13.0 ± 10.4 14.2 ± 12.2
1.0 to 52.0 10.2 to 62.0
80 (87%) 75 (86.2%)
83 (90.2%) 75 (86.2%)