Medical device firm Nevro has secured approval from the US Food and Drug Administration (FDA) for its new surgical leads for the Senza Spinal Cord Stimulation System delivering HF10 therapy.
The Senza system is claimed to be the only system that delivers the company’s HF10 therapy, an SCS therapy that offers electrical pulses to the spinal cord to relieve pain.
Small electrodes will deliver electrical pulses on leads, which are placed near the spinal cord. They are connected to a compact and battery-powered generator implanted under the skin.
HF10 therapy provides pain relief without paresthesia, a stimulation-induced sensation such as tingling or buzzing.
Nevro said the Senza system and HF10 therapy are covered by around 85 issued US and international patents.
Nevro chairman and CEO Michael DeMane said: "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 organization 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."