Medical device company Nevro has received the US Food and Drug Administration (FDA) approval for its Senza spinal cord stimulation (SCS) system.
The Senza SCS system delivers the firm’s proprietary HF10 therapy and can manage chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
HF10 therapy provides pain relief without paresthesia and is the only SCS therapy approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy.
It is labeled as superior to traditional SCS therapy for chronic back and leg pain.
The Senza system is the only implantable SCS system approved by FDA with labeling for 3T conditional MRI compatibility.
Wake Forest University Baptist Medical Center SENZA-RCT pivotal study lead investigator Dr Leonardo Kapural said: "The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional SCS, representing a tangible advance in chronic pain management.
"HF10 therapy will allow me to help more patients in my practice by addressing back pain in addition to leg pain. And, with HF10 therapy I can for the first time focus on providing pain relief to my patients instead of managing paresthesia, which is a paradigm shift for my pain practice."
Image: The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to directly compare SCS therapies. Photo: courtesy of Nevro Corp.