FDA Approves Spinal Cord System from Nevro

Menlo Park, Calif.-based Nevro Corp., a medical device company that makes solutions for the treatment of chronic pain, has received approval from the U.S. Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS) system.

The Senza SCS 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 been on the market in Europe and Australia over the past five years. HF10 is designed to deliver pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS) and can be used without patient restrictions on motor vehicle operation. The Senza system, which is implantable, is permitted by the FDA for use in an MRI (magnetic resonance imaging) scan at 3 Tesla strength.

The Senza system was the subject of the Senza-RCT pivotal study, the first to directly compare SCS therapies. The multicenter study was conducted across 11 U.S. clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients.

“My fellow investigators and I have eagerly awaited the approval of the Senza SCS system,” said Dr. Leonardo Kapural, M.D., Ph.D., lead investigator for the Senza-RCT pivotal study from Wake Forest University Baptist Medical Center, Winston-Salem, N.C. “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.”

“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 CEO of Nevro. “The Nevro organization is prepared to initiate a responsible rollout of HF10 therapy to the U.S. pain management community and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company.”