Durable Relief for Back and Leg Pain
The landmark SENZA-RCT² demonstrated long-term safety and improved efficacy for both back and leg pain with 10 kHz Therapy.
No other company has committed so fully to establishing clinical evidence for the safety and efficacy of a spinal cord stimulation (SCS) system with large-scale randomized clinical trials (RCTs) targeting indication expansion.
The landmark SENZA-RCT² demonstrated long-term safety and improved efficacy for both back and leg pain with 10 kHz Therapy.
Long-Term Responder Rates
In a real-world study3, chronic back pain patients achieved a 74% responder rate, mirroring the excellent outcomes of the SENZA-RCT.
Responder Rate vs.
CMM Arm at 6 Months
The SENZA-PDN, a large multi-center RCT, shows meaningful long-term pain relief with 10 kHz Therapy4.
The SENZA-NSRBP RCT, shows substantial pain relief outcomes with 10 kHz Therapy in comparison to CMM5.
1
Al-Kaisy A, Van Buyten J-P, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014;15:347-354.
2
Kapural L, et al. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-month Results from a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery. Published 09 2016
3
Stauss, T, et al. A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain. Annals of Clinical and Translational Neurology. Jan. 22, 2019. *Mean time from implant to last visit is nine months.
4
Petersen, E, et. al. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy A Randomized Clinical Trial. JAMA Neurology, April 2021.
5
Kapural, L. Jameson, J, Johnson, C et al. Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial. Journal of Neurosurgery: Spine (2022)..