Full-Body MRI Conditional Labeling Now Available in United States for Nevro Senza® Spinal Cord Stimulation System
REDWOOD CITY, Calif., March 22, 2018 /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 full-body magnetic resonance imaging (MRI) conditional labeling is now available in the United States for the Senza Spinal Cord Stimulation (SCS) System delivering HF10 therapy.
This labeling expansion, which is now applicable in all our markets, 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. This approval is retroactive, meaning that the new labeling for expanded imaging applies to all patients currently implanted with the Senza SCS System and percutaneous leads. It is anticipated that a similar labeling expansion will follow for the Senza II SCS system.
"Expanding full-body MRI conditional labeling is a significant milestone in our continued launch of the Senza System in the United States. The efforts of our R&D and regulatory teams secured this labeling expansion for both current and future patients enabling us to better help individuals with chronic pain who may have additional imaging needs," said Rami Elghandour, President and CEO of Nevro. "We are dedicated to constantly improving the Senza System and the HF10 patient experience to positively impact many more lives with our best in class therapy."
"I incorporated HF10 therapy into my practice because of the compelling clinical evidence, and continue to use it because of the outcomes and benefits I'm seeing first hand with my patients," said Dr. William S. Rosenberg, a Neurosurgeon at the Center for the Relief of Pain in Kansas City. "Adding this expanded full-body conditional MRI compatibility allows me to deliver this effective therapy to an even greater number of patients in pain, while giving all of my patients more available imaging options."
About the Senza® System and HF10® Therapy
The Senza® and Senza II™ systems are the only SCS systems that deliver 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 Senza II System and HF10 Therapy, are covered by more than 150 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, non-pharmacologic neuromodulation platform for the treatment of chronic pain. The Senza® System and Senza II™ System are the only SCS systems that deliver Nevro's proprietary HF10® therapy. Senza, Senza II, HF10, Nevro and the Nevro logo are trademarks of Nevro Corp.
In addition to historical information, this press release contains forward-looking statements with respect to our business, reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including our expectation of receiving full-body MRI conditional labeling of the Senza II SCS System. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties. These factors are described in greater detail in our Annual Report on Form 10-K that we filed on February 22, 2018, as well as any reports that we may file with the SEC in the future, and may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
Investor Relations Contact:
Nevro Investor Relations
View original content with multimedia:http://www.prnewswire.com/news-releases/full-body-mri-conditional-labeling-now-available-in-united-states-for-nevro-senza-spinal-cord-stimulation-system-300618433.html
SOURCE Nevro Corp.
Company Codes: NYSE:NVRO