Nevro got a CE mark for a new version of its spinal cord stimulation (SCS) therapy for chronic pain.
Nevro’s Senza II SCS system is smaller than its original Senza device but provides the same HF10 therapy, the company said. The device delivers electrical pulses to the spinal cord to relieve chronic pain in the back and legs.
The new device “is a step forward that represents our company’s commitment to continuously advancing our product portfolio,” Nevro CEO Rami Elghandour said in a statement. “We look forward to initiating a controlled rollout in Europe.”
A European signoff for Senza II marks a high point for Nevro. The Redwood, Calif.-based company, a former FierceMedTech 15 winner, got FDA approval for Senza in May 2015 based on promising data. Nevro touts Senza as superior to other pain management devices because it doesn’t lead to paresthesia, an uncomfortable side effect that produces a pins-and-needles sensation.
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Still, some payers have been skeptical that the technology can deliver on its promise. In April 2016, Blue Cross Blue Shield Tennessee and Highmark BCBS Pennsylvania released policies characterizing Senza as experimental.
Leerink analyst Danielle Antalffy remained optimistic about Nevro, though, saying there was a “high likelihood” that payers would reverse their decision. That proved to be an accurate prediction. Both payers now list high-frequency stimulation as "medically necessary" for the treatment of pain in certain circumstances.
Nevro is also on track to rack up a reimbursement success in Europe, with U.K. cost watchdog NICE giving the device a favorable review in recent draft guidance.
"The case for adopting Senza for delivering high frequency spinal cord stimulation to treat chronic neuropathic back and leg pain is supported by the evidence. It is associated with better pain control than low frequency spinal cord stimulation. It also improves quality of life, reduces functional disability and avoids the tingling sensation patients can experience with low frequency spinal cord stimulation," NICE wrote in its draft guidance (PDF).
Nevro’s Senza device has already shown promising results in studies. In September 2016, the company celebrated positive two-year results for Senza.
Data published in the journal Neurosurgery showed that Nevro’s device and corresponding HF10 therapy was better at reducing chronic pain than traditional therapies. Senza met its primary and secondary endpoints in the study.
The results show that Senza “is now backed by two comprehensive prospective studies, each with robust two-year outcomes, representing a meaningful advance in the field of neuromodulation,” Elghandour said at the time. The data support "long-term positive outcomes for SCS and is critical for driving clinical and economic decision making among physicians, payers, and patients,” Elghandour said.
Editor's note: An earlier version of this story incorrectly stated Nevro faced ongoing payer challenges. We regret the error.