Nevro has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation system. Nevro also announced that it will now be releasing financial results for the first quarter of 2015 before market open on Monday, 11 May, 2015. The company will be hosting a conference call beginning at 8:30 a.m. Eastern Time to discuss both the FDA approval and first quarter operating results in place of the conference call previously scheduled in the afternoon of the same day.
The Senza spinal cord stimulation system, which delivers Nevro’s proprietary HF10 therapy, is indicated as an aid in the management of 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.
The Senza system delivering HF10 therapy has experienced strong adoption in Europe and Australia over the past five years. With this FDA approval, patients in the US suffering from chronic pain will have the opportunity to experience the significant benefits of HF10 therapy. FDA approval of Nevro’s Senza system highlights the unique nature of the technological innovation:
- HF10 therapy is the only SCS therapy approved by FDA with superiority labeling;
- HF10 therapy is the only SCS therapy indicated by FDA to deliver pain relief without paraesthesia (a constant tingling sensation that is the basis of traditional spinal cord stimulation);
- HF10 therapy is the only spinal cord stimulation therapy approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy;
- The Senza system is the only implantable spinal cord stimulation system approved by FDA with labelling for 3T conditional MRI compatibility.
The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to directly compare spinal cord stimulation therapies. The multicentre study was conducted across 11 US clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients, making it the largest prospective randomised spinal cord stimulation study ever conducted to assess the treatment of chronic back and leg pain.
“My fellow investigators and I have eagerly awaited the approval of the Senza spinal cord stimulation system,” said Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center, USA. “The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional spinal cord stimulation, 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 paraesthesia, which is a paradigm shift for my pain practice.”
The labelling for the Senza system and HF10 therapy was based on the SENZA-RCT clinical trial, where HF10 therapy was meaningfully superior to traditional spinal cord stimulation therapy for back and leg pain, including superior response rates, pain relief, and functional outcomes. Superiority was demonstrated in the primary and all secondary endpoints including at every measurement time point throughout the 12-month follow up.
“We are grateful to the inspiring dedication of the clinical investigators, their study coordinators, and patients involved in the SENZA-RCT study, as they collectively have paved the way for this therapy to help those suffering from debilitating chronic pain,” said Michael DeMane, chairman and chief executive officer of Nevro. “The Nevro organisation is prepared to initiate a responsible rollout of HF10 therapy to the US pain management community and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company.”