FDA Approves Spinal Cord Stimulation System With Superiority Labeling
The FDA announced the approval the first implantable spinal cord stimulation (SCS) system to treat chronic back pain using high frequency (up to 10,000 Hz) stimulation without causing a common tingling side effect called paresthesia. Experts say Nevro’s Senza SCS system represents a significant advance in SCS technology, and it is the only system to be FDA approved with superiority labeling.
The Senza system, which has been approved for both the Australian and European markets for the past five years, delivers Nevro’s proprietary HF10 therapy through a device that is implanted in the thoracolumbar area of the spinal cord and is connected to a pulse generator implanted in the buttocks or abdomen. The device can be adjusted by the patient via remote control within a programed range chosen by the healthcare provider.
Though several implantable SCS systems are currently approved for the U.S. market, the FDA said in a press release that Nevro’s system was the first to offer treatment without paresthesia, a common side effect to SCS treatment that many patients find uncomfortable.
Leonardo Kapural, the lead investigator on the SENZA-RCET clinical study, said that by allowing clinicians to focus on pain relief without having to manage paresthesia, Nevro had achieved a breakthrough that was a “paradigm shift” in chronic back pain management.
Nevro reported in a press release that the clinical study showed a 50 percent reduction in pain after three months of therapy for 75 percent of trial participants.
“The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional SCS, representing a tangible advance in chronic pain management,” said Kapural.
Nevro also reported that the technology had been approved with superiority labeling and was the first SCS system that did not place restrictions on motor vehicle operation and that had approved labeling for 3T conditional MRI compatibility.
Michael DeMane, CEO of Nevro, said that the company was prepared to initiate a “responsible rollout” for Senza, and Bloomberg reported that the company was poised to collect a “meaningful share” of the current pain management market with this new product.
According to Bloomberg, Senza’s FDA approval is two months ahead of schedule, and after the U.S. joins the system’s approved markets, Nevro’s market value will jump to $1.2 billion.
The American Academy of Pain Medicine estimates that over 100 million Americans suffer from chronic pain, and this condition represents between $560 and $635 billion dollars per year in health care costs and lost wages.
Image credit: Nevro Corp.