Redwood City, CA — Nevro Corp. (NYSE:NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it 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.”
ABOUT THE SENZA SYSTEM AND HF10 THERAPY
The Senza system is the only SCS system that delivers Nevro’s proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS) and is also the first SCS therapy to demonstrate superiority to traditional SCS for back and leg pain in a comparative pivotal study. Nevro’s innovations in SCS, including the Senza® system and HF10™ therapy, are covered by more than 85 issued U.S. and international patents.
Headquartered in Redwood City, California , Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based neuromodulation platform for the treatment of chronic pain. The Senza system is the only SCS system that delivers Nevro’s proprietary HF10 therapy. Senza, HF10, Nevro and the Nevro logo are trademarks of Nevro .