Healthcare Industry News: Nevro Corp
News Release - July 10, 2012
First Patient Treated in Landmark U.S. Randomized Pivotal Trial of Nevro’s Chronic Pain TreatmentStudy to Evaluate Safety and Efficacy of Therapy Designed to Improve Pain Relief and Avoid Unpleasant Side Effects of Conventional Spinal Cord Stimulation
MENLO PARK, Calif.--(Healthcare Sales & Marketing Network)--Nevro Corp., a medical device company focused on improving pain relief among patients suffering from debilitating chronic pain, announced today that its Senza™ High-Frequency Spinal Cord Stimulation System has been implanted in the first patient to receive the device as part of the SENZA-RCT U.S. pivotal study.
The SENZA-RCT study is a prospective, randomized, controlled pivotal study intended to evaluate the safety and efficacy of Nevro’s Senza High-Frequency Spinal Cord Stimulation System in patients with chronic pain. The study will enroll approximately 300 patients at 15 leading pain centers across the U.S.
“We are pleased to be taking part in the landmark SENZA-RCT trial,” said Lora L. Brown, M.D., who conducted the first patient implant at Coastal Orthopedics Pain Management in Bradenton, Florida. “Previous studies of Nevro’s system suggest it is the first to provide substantial pain relief in patients with chronic back pain while avoiding the tingling, buzzing, and shocking side effects that occur with conventional spinal cord stimulation systems. If these findings are replicated in the current randomized study, the therapy could represent a major advance in the field of chronic pain management.”
About Spinal Cord Stimulation
Spinal cord stimulation is an established pain treatment that delivers electrical pulses to the spinal cord to mask the transmission of pain signals to the brain. The electrical pulses are delivered by small electrodes that are placed near the spinal cord and are connected to a compact battery powered generator implanted under the skin. While these electrical pulses can reduce pain, they typically trigger tingling and buzzing sensations, known as paresthesia, which most patients find unpleasant.
Nevro’s Senza System delivers similar electrical pulses, but at a higher frequency than existing devices. Data from European clinical studies suggest that Nevro’s proprietary, high-frequency waveform may be effective in treating low back pain and other challenging types of chronic pain that often do not respond to conventional spinal cord stimulation. Results also show that Nevro’s technology can deliver pain relief without paresthesia, allowing patients to experience, for the first time, true relief from chronic pain without unpleasant side effects.
Nevro’s Senza High-Frequency Spinal Cord Stimulation System is authorized for sale in Europe and Australia. In the United States, the system is limited by federal law to investigational use only and is not available for commercial use.
About Chronic Pain
Chronic pain is a widespread and often severely debilitating condition that is estimated to affect more than 100 million adults in the U.S. and to cost the nation up to $635 billion each year in medical treatment and lost productivity.1 Those suffering from chronic pain often report that pain interferes with their overall well-being and frequently leads to depression or anxiety. There is no known cure for chronic pain and treatment usually requires more than one therapy. In addition to spinal cord stimulation, current therapies to relieve chronic pain include surgery, pharmacology, acupuncture and behavior modification.
About Nevro Corp.
Privately held Nevro Corp., headquartered in Menlo Park, Calif., is focused on the development and commercialization of high-frequency spinal cord stimulation for chronic pain. The company’s proprietary high-frequency waveform technology appears unique in its potential to effectively treat challenging conditions such as low back pain while avoiding the typical side effects that can occur with currently available systems. Nevro’s investors include Johnson & Johnson Development Corporation, Bay City Capital, Three Arch Partners, Aberdare Ventures, MPM Capital and Accuitive Medical Ventures. For more information visit www.nevro.com.
Senza, Nevro and the Nevro logo are trademarks of Nevro Corp.
Caution – Investigational device, limited by Federal (or United States) law to investigational use.
1 Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington D.C.
Source: Nevro Corp
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