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.
Rami Elghandour, President and CEO of Nevro said, “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.” Elghandour adds, “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.”
Meanwhile a Neurosurgeon at the Center for the Relief of Pain in Kansas City, Dr. William S. Rosenberg reported, “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.” He concluded, “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.”
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.