FDA Approval for Nevro’s Surgical Leads for the Senza Spinal Cord Stimulation System

Nevro Corp., a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, has received U.S. Food and Drug Administration (FDA) approval for its surgical leads, which are specifically designed for use with the Senza Spinal Cord Stimulation (SCS) System delivering HF10 Therapy.
 
“Placement of surgical SCS leads is an important clinical option for many surgeons and their patients,” said Michael DeMane, chairman and CEO of Nevro. “With the approval of Nevro surgical leads, we can now enable more surgeons to deliver on the promise of HF10 therapy. Consistent with the U.S. launch of HF10 therapy, the Nevro organization is prepared to initiate a responsible and staged rollout to U.S. surgeons and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company.”
 
“My fellow surgeons and I have eagerly awaited the approval of this lead for the Senza SCS system,” said Dr. Ashwini D. Sharan, M.D., professor and program director of neurosurgery at Thomas Jefferson University. “In my practice, I have already witnessed the significant advantages of HF10 therapy, which provides superior pain relief for chronic back and leg pain patients. Now, with the ability to use surgical leads with the Senza SCS system, I look forward to providing Nevro’s therapy to a broader set of patients.”