The Redwood City, Calif.-based company said results from the study were published in the journal Neurosurgery. Nevro said the trial is the largest prospective randomized trial of SCS systems and the 1st to evaluate the comparative effectiveness of spinal cord stimulation therapies.
The primary endpoint for the trial was a responder rate signifying a greater-than 50% reduction in back pain from the baseline at 3 months, with a secondary endpoint set at 12 months. Leg pain reductions and 24 month results from back pain reduction were also polled for secondary endpoints.
Patients treated with the company’s HF10 SCS reported significant improvements in superior back pain and leg pain 76.5% and 72.9% respectively, much higher than the 49.3% rates reported with traditional SCS for both back and leg pain.
Superior and durable pain relief results also indicated superiority for the HF10, with Visual Analog Scale scores for back and leg pain of 2.4 cm with HF10 versus 4.5 cm and 3.9 cm with traditional SCS, according to the study.