The United States Food and Drug Administration (FDA) has approved Nevro's Senza spinal cord stimulation (SCS) system.
The Senza SCS system, which delivers Nevro's proprietary HF10 therapy, can aid in the management of chronic intractable pain of the trunk and limbs. The chronic intractable pain includes unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
The Senza system has experienced strong adoption in Europe and Australia over the past 5 years. With the approval, patients in the US suffering from chronic pain will have the opportunity to experience the significant benefits of HF10 therapy.
The Senza system was the subject of the SENZA-RCT pivotal study. The ground-breaking study was the first to directly compare SCS therapies. The multicenter compared the safety and effectiveness of HF10 therapy to traditional SCS therapy.
"My fellow investigators and I have eagerly awaited the approval of the Senza SCS system. 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," said Dr. Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center.