The US Food and Drug Administration (FDA) has granted approval to medical device firm Nevro’s surgical leads, designed to be used with the Senza Spinal Cord Stimulation (SCS) System delivering HF10 Therapy.
The Senza system is claimed being the only SCS system, an evidence-based neuromodulation platform that delivers Nevro’s patented HF10 therapy, which is an SCS therapy issuing electrical pulses to the spinal cord to decrease pain.
The electrical pulses are delivered by small electrodes on leads, which are placed at the vicinity of the spinal cord and 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, and comparative pivotal study has proved that HF10 is the first such SCS therapy to exhibit better results when compared to the existing SCS for back and leg pain.
Paresthesia is a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS.
Thomas Jefferson University Neurosurgery professor and programme director Dr Ashwini Sharan said: "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."
Nevro’s innovations in SCS, including the Senza system and HF10 therapy, are utilised by more than 85 issued US and international patents.