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.
   

HF10TM Therapy: Sustained Superiority to Traditional SCS at 24 Months1

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.

SENZA-RCT: Responder Rates1

Superior Long-Term Back and Leg Pain Response with HF10 Therapy

n = 156

p-value back < 0.001

p-value leg = 0.003

SENZA-RCT: Pain Reduction1

SUPERIOR BACK PAIN RELIEF WITH HF10 THERAPY

SUPERIOR LEG PAIN RELIEF WITH HF10 THERAPY

12 months: n = 171, p-value back < 0.001, p-value leg < 0.001
24 months: n = 156, p-value back < 0.001, p-value leg = 0.027

SENZA-RCT: Functional Outcomes1

Superior ODI improvement with HF10 therapy

SENZA-RCT: Patients reporting uncomfortable stimulation2

HF10 therapy is the only paresthesia-free SCS therapy



MONTH 3
MONTH 12
HF10 THERAPY
CONTROL (TRADITIONAL)
n=90 n=81
0 (0%) 33 (46.5%)
0 (0%) 28 (44.4%)

SENZA-RCT: Equivalent Safety Profile to Traditional SCS2



Study related serious adverse events (SAEs)
Study related SAEs (including neurological deficit)
SAEs by outcome
Unanticipated device related SAEs
Deaths
HF10 THERAPY
CONTROL (TRADITIONAL)
Number of SAEs # (%) Subjects with SAEs (n=101) Number of SAEs # (%) Subjects with SAEs (n=97)
5 4 (4.0%) 8 7 (7.2%)
0 0 (0.0%) 0 0 (0.0%)


0 0 (0.0%) 0 0 (0.0%)
1 1 (1.0%) 1 1 (1.0%)

HF10 therapy subject death due to hepatocellular carcinoma at month 13; traditional SCS subject death due to myocardial infarction during IPG implant procedure.

Uncomfortable Paresthesias
Implant site pain
Lead migration
HF10 THERAPY
CONTROL (TRADITIONAL)
Number of AEs # (%) Subjects with AEs (n=101) Number of AEs # (%) Subjects with AEs (n=97)
0 0 (0.0%) 11 11 (11.3%)
12 10 (9.9%) 11 10 (10.3%)
3 3 (3.0%) 5 5 (5.2%)

SENZA-RCT & SENZA-EU Studies: Demonstrated Reproducibility1,3