One of the most debilitating and intolerable effects of Failed
Back Surgery Syndrome (FBSS) is the chronic pain in the low back and leg,
lasting long after surgery.
Additionally, any conventional spinal cord stimulation treatment
(SCS) used to relieve this pain very often leaves the patient with the
undesirable side effects of paresthesia (i.e., numbness, tingling, buzzing and
shock-like sensations).
Conventional SCS devices are commonly used to alleviate
chronic pain. However, they have
been only moderately effective in alleviating leg pain (i.e., sciatica, nerve
root compression symptoms) and even less effective in relieving associated low
back pain. Moreover, conventional
SCS treatment produces a variety of uncomfortable tingling, buzzing and
shock-like side effects (paresthesia).
The bioengineers at the Nevro Corp have high
expectations. They’ve developed a
medical device designed to alleviate the chronic, debilitating pain in patients
suffering from Failed Back Surgery Syndrome, with the added benefit of
eliminating the paresthesia effects.
The Nevro device (Senza – RCT) is a high-frequency spinal
cord stimulation (SCS) system implanted near the pain-generating site. Small electrodes with batteries,
implanted alongside the spinal cord, emit high-frequency electromagnetic pulses
to the spinal cord to mask the transmission of pain signals to the brain.
The Nevro System operates like conventional devices but
delivers electromagnetic pulses at a much higher, more effective frequency. The
Senza-RCT claims a two-fold advantage over conventional systems: 1. It provides prolonged pain relief in
the low back and legs, and 2. It has none of the undesirable paresthesia side
effects (I.E., numbness, tingling, buzzing sensations).
The FDA has approved the Nevro System for investigational
use only. Controlled studies are
now being done to evaluate its safety and efficacy.
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