FDA approves new leads for Nevro’s Senza spinal cord stimulator

Nevro Corp. (NYSE:NVRO) said it won pre-market approval from the FDA for new surgical leads designed to be used with its Senza spinal cord stimulation device.

The Senza device, which won an FDA nod in May 2015, is designed to deliver high-frequency electrical impulses of up to 10,000Hz  to the spinal cord to avoid the tingling sensation known as paresthesia that bothers some SCS patients. The FDA approval allows Redwood City, Calif.-based Nevro to label the device’s HF10 therapy \ as superior to conventional spinal cord stimulators.

“Placement of surgical SCS leads is an important clinical option for many surgeons and their patients,” chairman & CEO Michael DeMane, who’s slated to leave the corner office June 1, said in prepared remarks. “With the approval of Nevro surgical leads, we can now enable more surgeons to deliver on the promise of HF10 therapy. Consistent with the U.S. launch of HF10 therapy, the Nevro organization is prepared to initiate a responsible and staged rollout to U.S. surgeons and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company.”

“My fellow surgeons and I have eagerly awaited the approval of this lead for the Senza SCS system,” added Dr. Ashwini Sharan of Philadelphia’s Thomas Jefferson University. “In my practice, I have already witnessed the significant advantages of HF10 therapy, which provides superior pain relief for chronic back and leg pain patients. Now, with the ability to use surgical leads with the Senza SCS system, I look forward to providing Nevro’s therapy to a broader set of patients.”

Founded in 2006, Nevro has been led since 2011 by ex-Medtronic (NYSE:MDT) COO DeMane. The company has raised more than $153 million so far from backers including Johnson & Johnson (NYSE:JNJ), Covidien, Novo Nordisk and New Enterprise Assoc. A Series C round brought in $48 million in 2014.

Nevro shares surged in January of that year, when the FDA sent the company an approvable letter for the Senza device. Nevro went public in November 2014 in a $145 million flotation.

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