Nevro Receives CE Mark for Full-Body MRI Conditional Labeling with the Senza® Spinal Cord Stimulation System
Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility
REDWOOD CITY, California, Nov. 15, 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 full-body magnetic resonance imaging (MRI) conditional labeling on the Senza Spinal Cord Stimulation (SCS) System delivering HF10™ Therapy.
This approval (which is applicable only to European Economic Area countries) adds to the previous labeling allowing head and extremity MRI scans, broadening the pool of patients who are eligible to receive the Senza SCS System, including both model IPG1000 and IPG1500. This approval is retroactive, meaning that the new labeling for expanded imaging applies to all patients currently implanted with the Senza SCS System with percutaneous leads.
"Our R&D and regulatory teams worked hard to secure this approval for both current and future Senza patients," said Rami Elghandour, President and CEO of Nevro. "We believe in expanding patient access to HF10 Therapy and this approval enables us to help chronic pain patients who may have additional imaging needs. We are dedicated to continually improving on the Senza System to not only deliver superior patient outcomes, but also provide the best patient experience in the SCS space."
"HF10 Therapy is life-changing for my patients," said Dr. Mohammad Maarouf, MD, Associate Professor and Head of the Department of Stereotaxy and Functional Neurosurgery at Cologne Merheim Medical Center, University of Witten/Herdecke, Germany. "I am happy that all of my patients past and future now have access to superior outcomes with the reassurance that patients with percutaneous systems can safely have a full-body MRI should the need arise."
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 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 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, 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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