Nevro Corp., a medical device company focused on achieving improved pain
relief for patients suffering from debilitating chronic pain, today
announced that the U.S. Food and Drug Administration (FDA) has granted
approval for initiation of its SENZA-RCT study, a U.S. prospective,
randomized, controlled pivotal clinical trial evaluating the safety and
efficacy of Nevro's high-frequency spinal cord stimulation system for
the treatment of chronic pain.
Spinal cord stimulation is an established pain treatment that delivers
electrical pulses to the spinal cord to mask the transmission of pain
signals to the brain. The electrical pulses are delivered by small
electrodes that are placed near the spinal cord and are connected to a
compact battery powered generator implanted under the skin. While these
electrical pulses can reduce pain, they are often associated with
unpleasant tingling and buzzing sensations known as paresthesia.
Nevro's Senza™ High-Frequency Spinal Cord Stimulation (HF-SCS) System
delivers similar electrical pulses but at a higher rate than currently
available devices. Data from previous European clinical studies suggest
that Nevro's proprietary high-frequency waveform may be effective in
treating low back pain and other challenging types of chronic pain that
often do not respond to conventional spinal cord stimulation. Data also
show that Nevro's technology can deliver pain relief without
paresthesia, which has allowed many patients in countries where the
system is available to experience, for the first time, true relief from
chronic pain without unpleasant side effects.
"There is a real, unmet need for additional treatment options for
chronic pain patients," said Leonardo Kapural, M.D., Ph.D, medical
director of Wake Forest University Health Sciences, Chronic Pain Center
in Winston-Salem, N.C., who serves as the principal investigator for the
SENZA-RCT trial. "Early studies suggest that high-frequency spinal cord
stimulation may expand the group of patients treatable with spinal cord
stimulation therapy while eliminating paresthesia, a highly unpleasant
side effect of current systems. If these benefits are confirmed in the
SENZA-RCT study, Nevro's high-frequency spinal cord stimulation system
could represent an important breakthrough in the management of chronic
The SENZA-RCT study is a prospective, randomized, controlled pivotal
trial that will enroll approximately 300 patients across up to 15 U.S.
centers. The study is the first to include active spinal cord
stimulation systems in both arms of the trial. Patients will be
randomized to receive either Nevro's high-frequency or conventional
low-frequency spinal cord stimulation.
Early Studies Show Promising Results
Clinical research from an earlier, prospective, European study found
that high-frequency spinal cord stimulation offered significant and
sustained pain reduction in patients with chronic back and leg pain.
Of the 83 patients enrolled in the study, 87 percent presented with
predominant back pain and 81 percent had failed prior back surgery.
Patients reported pain using the Visual Analog Scale (VAS), a widely
accepted pain measurement scale. Results of the study showed that
following treatment with Nevro's Senza System, average back pain scores
dropped from 8.4 at baseline to 2.7 at six-month follow-up, with a
median reduction in pain score of 78%. Average leg pain scores were
reduced from 5.4 at baseline to 1.4 at six months, with a median
reduction of 83%. Pain reduction was sustained out to one year. These
results were achieved without patients experiencing paresthesia.
"Results from this initial clinical study suggest high-frequency spinal
cord stimulation may be effective in patients who have debilitating back
pain, a group that is typically very difficult to treat," said
Jean-Pierre Van Buyten, M.D., chairman of the Multidisciplinary Pain
Center AZ Nikolaas Sint-Niklaas, Belgium. "Nevro's treatment has allowed
many of my patients to go from bed rest to a more active life."