Nevro has announced that it has received US 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,” says Michael DeMane, chairman and chief executive officer 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 US launch of HF10 therapy, the Nevro organisation is prepared to initiate a responsible and staged rollout to US 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,” says Ashwini D Sharan, professor and program director of Neurosurgery at Thomas Jefferson University, USA. “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.”
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 paraesthesia (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.