Devices & Diagnostics

Nevro gets FDA pre-market approval for spinal cord stimulation device

The Redwood City, California-based company previously got an FDA nod in May 2015 for the device, which delivers high-frequency electrical impulses of up to 10,000Hz to the spinal cord to avoid the tingling sensation known as paresthesia (HF10 therapy).

spine

Nevro Corp. has won pre-market approval from the Food and Drug Administration for its Senza spinal cord stimulation device.

The Redwood City, California-based company previously got an FDA nod in May 2015 for the device, which delivers high-frequency electrical impulses of up to 10,000 hertz to the spinal cord to avoid the tingling sensation known as paresthesia (HF10 therapy).

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It is designed to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin.

“My fellow surgeons and I have eagerly awaited the approval of this lead for the Senza SCS system,” Dr. Ashwini D. Sharan, program director of neurosurgery at Thomas Jefferson University in Philadelphia, said in a statement. “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.”

Nevro was founded in 2006 and has been led since 2011 by ex-Medtronic COO Michael DeMane. The company has raised more than $153 million so far from backers including Johnson & Johnson, Covidien, Novo Nordisk and New Enterprise Associates. In a Series C round in 2014, the company brought in $48 million.

Photo: Flickr user Michael Dorausch