Nevro Receives CE Mark for Senza II™ Spinal Cord Stimulation System Delivering HF10™ Therapy
Superior, Non-Opioid Therapy Now Delivered in a Smaller and More Refined IPG
REDWOOD CITY, California, Nov. 30, 2017 /PRNewswire/ -- Nevro Corp. (NYSE:NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received CE Mark for its next-generation Senza II Spinal Cord Stimulation (SCS) System delivering HF10 therapy. The Senza II system offers the superior outcomes and clinical advantages of HF10 therapy through a smaller and more refined footprint while maintaining the performance and durability of the current Implantable Pulse Generator (IPG).
"My colleagues and I have eagerly awaited the approval of the Senza II SCS system," said Dr. Adnan Al-Kaisy, M.D., clinical lead and consultant in the Pain Management and Neuromodulation department at Guy's and St Thomas' Hospital in the UK. "The reduced size and optimised design of the Senza II IPG allow for greater patient comfort and placement options. This is further advancement of a device that seven years ago revolutionised treatment for chronic back and pain sufferers by providing profound and paresthesia-free pain relief."
"Senza II is a step forward that represents our company's commitment to continuously advancing our product portfolio," said Rami Elghandour, President and CEO of Nevro. "The smaller, refined footprint delivers the unparalleled performance of our current Senza system and is backed by the same best-in-class clinical evidence that you've come to expect from Nevro and HF10 therapy. We look forward to initiating a controlled rollout in Europe."
About the Senza II System and HF10 Therapy
The Senza II system (which is available only in European Economic Area countries) 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 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® and Senza II™ systems and HF10™ therapy, are covered by more than 140 issued U.S. and international patents.
About Nevro
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, non-pharmacologic neuromodulation platform for the treatment of chronic pain. The Senza system is the only SCS system that delivers Nevro's proprietary HF10 therapy. Senza, Senza II, HF10, Nevro and the Nevro logo are trademarks of Nevro.
Investor Relations Contact:
Nevro Investor Relations
Katherine Bock
+1 (650) 433-3247
ir@nevro.com
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