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HFX Meaningful Evidence - USA
USA

Region

USA

Industry-leading Clinical
Evidence in SCS

The Most Robust Body of Clinical Evidence

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.

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.

View the Senza-RCT

Long-Term Responder Rates

Reproducible Real-World Outcomes

In a real-world study3, chronic back pain patients achieved a 74% responder rate, mirroring the excellent outcomes of the SENZA-RCT.

VIEW THE PUBLICATION

Responder Rate vs.
CMM Arm at 6 Months

(≥ 50% relief)

Demonstrated Pain Relief for PDN

The SENZA-PDN, a large multi-center RCT, shows meaningful long-term pain relief with 10 kHz Therapy4.

VIEW THE PUBLICATION

Durable Outcomes for Non-Surgical Back Pain Patients

The SENZA-NSRBP RCT, shows substantial pain relief outcomes with 10 kHz Therapy in comparison to CMM5.

VIEW THE PUBLICATION

  • 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)..