Healthcare Industry News: neuromodulation
News Release - September 6, 2016
Publication of Two-Year SENZA-RCT Results in Neurosurgery Demonstrates Sustained Superiority of HF10(TM) Therapy over Traditional Spinal Cord Stimulation for Chronic PainREDWOOD CITY, Calif., Sept. 6, 2016 -- (Healthcare Sales & Marketing Network) -- Nevro Corp. (NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced the publication of long-term data for the treatment of chronic pain in Neurosurgery, the official Journal of the Congress of Neurological Surgeons. The SENZA-RCT is a groundbreaking pivotal study that was both the largest prospective randomized clinical trial ever conducted in SCS history and the first to evaluate comparative effectiveness of spinal cord stimulation (SCS) therapies.
The published two-year results demonstrate the sustained superiority of HF10 therapy versus traditional low-frequency SCS therapy across all primary and secondary endpoints. Significant findings from the SENZA-RCT study include:
- Superior back pain responder rate with HF10 therapy: 76.5% versus 49.3%; P<0.001
- Superior leg pain responder rate with HF10 therapy: 72.9% versus 49.3%; P=0.003
- Superior and durable pain relief with HF10 therapy: average VAS scores for back and leg pain of 2.4 cm with HF10 therapy versus 4.5 cm and 3.9 cm with traditional SCS; P<0.001 and P=0.027
- HF10 therapy delivered pain relief with no paresthesia or paresthesia-related discomfort
- Consistent safety results with limited study-related serious adverse events in each treatment group at two years (5.0% for HF10 therapy, 7.2% for traditional SCS; P=0.56)
"Nevro is committed to delivering innovative, evidence-based therapies that significantly improve outcomes for patients living with chronic pain," said Rami Elghandour, President and CEO of Nevro. "HF10 therapy is now backed by two comprehensive prospective studies, each with robust two-year outcomes, representing a meaningful advance in the field of neuromodulation. We are honored to have this data published in the prestigious Neurosurgery journal, which has a rich history of publishing seminal SCS clinical trials including the Kumar (PROCESS, 2008) and North (2005) studies. This Level I RCT supports long-term positive outcomes for SCS and is critical for driving clinical and economic decision making among physicians, payers, and patients."
The Senza® SCS system received FDA approval in May of 2015. The 12-month results of the SENZA-RCT, first presented by Dr. Leonardo Kapural at the North American neuromodulation Society meeting in December of 2014, provided the evidentiary basis for HF10 therapy's superiority labeling from FDA, a first in the SCS space. The two-year results of the SENZA-RCT were first presented by Dr. Todd Sitzman at the North American neuromodulation Society meeting in December of 2015.
The full two-year SENZA-RCT publication is available at http://journals.lww.com/neurosurgery/Abstract/publishahead/Comparison_of_10_kHz_High_Frequency_and.97253.aspx.
About the Senza System and HF10 Therapy
The Senza system is the only SCS system that delivers Nevro's proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered pulse generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS) and is also the first SCS therapy to demonstrate superiority to traditional SCS for back and leg pain in a comparative pivotal study. Nevro's innovations in SCS, including the Senza® system and HF10™ therapy, are covered by more than 100 issued U.S. and international patents.
Headquartered in Redwood City, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based neuromodulation platform for the treatment of chronic pain. The Senza system is the only SCS system that delivers Nevro's proprietary HF10 therapy. Senza, HF10, Nevro and the Nevro logo are trademarks of Nevro.
Source: Nevro Corp
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