The 10kHz stimulation system is said to be the only FDA approved spinal cord stimulation system with a specific indication to treat PDN
Nevro Omnia System. (Credit: Nevro Corp.)
Nevro has received the US Food and Drug Administration (FDA) approval for its Senza System for the treatment of chronic pain related to Painful Diabetic Neuropathy (PDN).
Nevro stated that its 10kHz stimulation system is the only FDA approved spinal cord stimulation system with a specific indication to treat PDN.
The company intends to immediately commence the commercial roll out of its Senza System in the US, under its recently launched HFX branding, as HFX for PDN.
Nevro president, chief executive officer and chairman D Keith Grossman said: “This FDA approval marks a capstone achievement that demonstrates the strength of our clinical data and provides a proven, new breakthrough SCS treatment option for PDN patients.
“We are thrilled that we can now begin commercial launch activities in the U.S. and believe this new indication will be an important driver of the long-term growth of our business for years to come.”
“We would like to thank lead Principal Investigator Dr. Erika Petersen and the entire team of clinical trial investigators and their patients for their study participation and ongoing partnership, without whom this approval would not have been possible.”
In the clinical trials, participants treated with 10 kHz Spinal Cord Stimulation (SCS) showed significantly substantial, sustained pain relief and improved health-related quality of life.
Nevro presented the six-month results, 12-month follow-up results and six-month crossover patient data from SENZA-PDN, a randomised controlled trial (RCT) of Senza System.
It intends to use the data to support physician referral decisions, along with market access initiatives to expand payer coverage for the stimulation procedure.
Nevro is expected to execute phased commercialisation of the product in the UK, Germany and Australia, with plans for further expansion in 2022.
The company anticipates a mid-single-digit million revenue contribution from PDN in 2021 and extended penetration and revenue contribution expected in 2022 and beyond.
SENZA-PDN study lead investigator Erika Petersen said: “The substantial pain relief and improved quality of life demonstrates that 10 kHz Therapy can safely and effectively treat this patient population.
“I’m grateful to my co-investigators and the patients who participated in this study, as the results and this approval will have far-reaching impact on the lives of PDN patients.”