Nevro (NYSE:NVRO) said yesterday that the FDA approved MRI-conditional labeling for its Senza spinal cord stimulation system designed to deliver HF10 therapy.
The Redwood City, Calif.-based company said that with the labeling expansion, its devices are now cleared as MRI-safe in all its markets. The approval is retroactive, the company added, applying to all patients implanted with the device and its leads.
“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. 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,” prez & CEO Rami Elghandour said in a prepared statement.
Nevro said it is hopeful that it will win a similar labeling expansion for its Senza II SCS system.
“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. 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,” Dr. William Rosenberg of Kansas City’s Center for the Relief of Pain said in a prepared statement.
Last month, Nevro posted fourth quarter earnings, reiterating its sales outlook for the rest of the year and saying it still expects to post a top line of $400 million to $410 million, but the company missed the consensus earnings forecast by a penny.
